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PubMed2001

Rufinamide: a double-blind, placebo-controlled proof of principle trial in patients with epilepsy.

OBJECTIVE: This was the first proof of principle clinical trial assessing the efficacy and safety of rufinamide as adjunctive therapy in epileptic patients. The pharmacokinetic (PK) profile of rufinamide was also determined. METHODS: Fifty patients with diagnoses of partial or primary generalized tonic-clonic seizures were enrolled in this 28-day double-blind, placebo-controlled, weekly rising dose (400-1600 mg/day) trial. PK profiles were obtained after administration of single-dose rufinamide prior to and after the Double-blind phase. RESULTS: In the evaluable patient population, seizure frequency decreased by 41% in the rufinamide group and increased by 52% in the placebo group (P=0.040). Thirty-nine percent (39%) of rufinamide-treated and 16% of placebo-treated patients experienced reduction in seizure frequency of at least 50% relative to baseline (P=0.096). SAFETY: Treatment-emergent adverse events (AEs) consisted mainly of neurologic signs and symptoms commonly associated with antiepileptic drugs (AEDs). PHARMACOKINETICS: At steady state, rufinamide reached a peak plasma concentration with a mean time (Tmax) of 3.4 h and a mean half-life (t1/2) of 7.3 h. No autoinduction of rufinamide metabolism occurred. Rufinamide did not influence the plasma concentration of carbamazepine, phenytoin or valproate when added to these single AED regimens. CONCLUSION: Rufinamide has been shown, in this proof of principle trial, to be safe and effective in reducing seizure frequency in epileptic patients with no relevant influence on the metabolism of other AEDs.

Adult↗
PubMed1991

The day-long antianginal effectiveness of nitroglycerin patches. A double-blind study using dose-titration.

This study was designed to determine the day-long antianginal effectiveness of nitroglycerin patches in the nitrate-exposed patient, as well as the doses required. Eight men with chronic stable angina, a positive treadmill test, and demonstrated responsiveness to long-term oral isosorbide dinitrate were studied after they had been taking effective doses of isosorbide dinitrate three times a day for at least two weeks. Treadmill exercise bouts were performed every 1 to 2 hours over 1 day, after the 8 am application of active nitroglycerin patches in a previously titrated dose, and on another day after application of placebo patches. Mean necessary effective patch dose was 125 sq cm (60 to 220 sq cm). Mean exercise duration to angina rose from 271 to 480 s (p less than 0.001) 1 hour after active patches, while resting systolic blood pressure fell from 122 mm Hg to 100 mm Hg (p less than 0.001). (After placebo patches: +19 s and -2 mm Hg, respectively.) Active patches were superior to placebo throughout the day, but in declining degree (by 94 s at 7 pm, p less than 0.05). Thus, nitroglycerin patches can provide a significant day-long antianginal effect in the patient with long-term exposure to nitrate. However, the need for large doses and individual titration may make this therapy impractical.

Administration, Cutaneous↗
PubMed2006

Tadalafil dosed once a day in men with erectile dysfunction: a randomized, double-blind, placebo-controlled study in the US.

The efficacy and safety of tadalafil, dosed once a day for the treatment of erectile dysfunction, was assessed in a randomized, double-blind, placebo-controlled, parallel-design study at 15 US centers. Following a 4-week treatment-free run-in period, patients (>or=18 years of age) were randomly assigned to 24 weeks treatment with tadalafil 2.5 mg, tadalafil 5 mg or placebo. Primary efficacy endpoints were change at 24 weeks in International Index of Erectile Function Erectile Function (EF) Domain score and mean per-patient percentage 'yes' responses to Sexual Encounter Profile diary questions 2 and 3. Tadalafil significantly improved erectile function compared with placebo for all three co-primary efficacy endpoints. Few patients discontinued because of adverse events (2.1%, placebo; 6.3%, tadalafil 2.5 mg; 4.1%, tadalafil 5 mg). Common treatment-emergent adverse events (>or=5%) were nasopharyngitis, influenza, viral gastroenteritis and back pain. Tadalafil 2.5 mg and 5 mg, dosed once a day for 24 weeks, was well tolerated and significantly improved erectile function.

Adult↗
PubMed1982

A therapeutic and discontinuation study of clobazam and diazepam in anxiety neurosis.

The efficacy and safety of clobazam and diazepam were compared in 40 patients with generalized anxiety disorder in a 28 day non-placebo-controlled trial followed by a 3-day single-blind placebo washout. The two drugs were equally anxiolytic, and the anxiety symptoms of most patients were brought under control within 1 week. Both drugs were found to be nontoxic. Diazepam had slightly greater sedative properties than clobazam, which was the patients' preferred drug after 28 days of treatment. During placebo washout, anxiety returned to pretreatment levels. Abrupt withdrawal did not result in rebound phenomena.

Adult↗
PubMed1990

Does alternate-day cloprednol therapy prevent bone loss? A longitudinal double-blind, controlled clinical study.

Osteoporosis is a serious side effect of systemic treatment with steroids. Cloprednol, a synthetic glucocorticoid with an anti-inflammatory potency twice that of prednisone, causes less calcium and nitrogen excretion than does prednisone in equipotent doses. Therefore a double-blind study was undertaken comparing the effects of alternate-day cloprednol and prednisone therapy on bone mineral density in 39 patients (cloprendol: 13 men and 8 women aged 48.5 +/- 2.8 years; prednisone: 9 men and 9 women aged 49.7 +/- 1.7 years) with lung diseases. Ten patients with asthma (9 men and 1 woman aged 37.8 +/- 3.7 years) inhaling daily beclomethasone served as control subjects. Trabecular and total bone density of the distal tibia and radius was determined quarterly during 1 year with a special-purpose computed tomographic system. Initial mean trabecular bone density of the patients receiving cloprednol and prednisone was 17% below normal. After a treatment period of 1 year, we found a loss of radial trabecular bone density (mean +/- SEM) of 1.33% +/- 0.49% in the cloprednol group and 2.38% +/- 0.69% in the prednisone group. In postmenopausal women, prednisone but not cloprednol therapy caused significant (p less than 0.01) trabecular bone loss (5.29% +/- 0.99% versus 0.70% +/- 0.65%). The control group lost 0.91% +/- 0.79%. Loss of cortical bone was insignificant in all three groups. In post-menopausal women, 1 year of alternate-day cloprednol therapy was associated with significantly less bone loss than was prednisone therapy in equipotent dosages.

Administration, Inhalation↗
PubMed1992

A double-blind comparison of paroxetine, imipramine, and placebo in major depression.

Results from a single-center, 6-week, double-blind, randomized prospective study of paroxetine, a selective serotonin reuptake inhibitor; imipramine; and placebo are reported. One hundred twenty outpatients with a moderate-to-severe DSM-III diagnosis of major depression were randomly assigned to one of the three treatments following a 4- to 10-day single-blind placebo washout period. Significant differences favoring paroxetine over placebo were present at endpoint on most major efficacy measures. Paroxetine was also well tolerated; 5 (15%) paroxetine and 5 (14%) placebo patients dropped out of the study due to adverse effects. Imipramine, however, was comparatively poorly tolerated. Forty-five percent of imipramine-treated patients (N = 17) dropped out of the study due to adverse effects. None of the efficacy measures showed a significant difference between imipramine and placebo. This finding was probably due to the high number of imipramine patients who discontinued before they could improve. These results support the efficacy of paroxetine in the treatment of major depression and underline its favorable side effect profile compared with tricyclic antidepressants.

Adult↗
PubMed2005

Once-daily azithromycin for 3 days compared with clarithromycin for 10 days for acute exacerbation of chronic bronchitis: a multicenter, double-blind, randomized study.

STUDY OBJECTIVES: To compare the efficacy and safety of oral azithromycin 500 mg once daily for 3 days with those of oral clarithromycin 500 mg twice daily for 10 days. DESIGN: Randomized, double-blind, double-dummy, multicenter study. SETTING: Seventy-six study centers in eight countries (Argentina, Brazil, Canada, Chile, Costa Rica, India, South Africa, and USA). PATIENTS: Three hundred and twenty-two adult outpatients with acute exacerbation of chronic bronchitis (AECB) as documented by increased cough or sputum production, worsening dyspnea, and purulent sputum production. INTERVENTIONS: Randomization 1 : 1 to azithromycin 500 mg once daily for 3 days or clarithromycin 500 mg twice daily for 10 days. RESULTS: The primary efficacy endpoint was clinical response at day 21-24, or test of cure (TOC) visit in the modified intent-to-treat (MITT) analysis (n = 318 patients). The TOC clinical cure rates in the MITT population were equivalent in the two treatment groups at 85% with azithromycin and 82% with clarithromycin (95% CI -5.9%, 12.0%). Clinical success rates on day 10-12 were also equivalent at 93% with azithromycin and 94% with clarithromycin (95% CI -7.9%, 4.4%). Clinical cure rates at TOC by pathogen were equivalent for the two treatment groups for Haemophilus influenzae (azithromycin, 85.7%; clarithromycin, 87.5%), Moraxella catarrhalis (91.7% and 80.0%, respectively) and Streptococcus pneumoniae (90.6% and 77.8%, respectively). Bacteriologic success rates were also equivalent between the azithromycin and clarithromycin treatment groups at TOC for S. pneumoniae (90.6% and 85.2%, respectively), H. influenzae (71.4% and 81.3%, respectively) and M. catarrhalis (100% and 86.7%, respectively). The overall incidence of treatment-related adverse events was similar in the azithromycin and clarithromycin groups (20.9% and 26.8%, respectively), with the most common being abdominal pain (6.3% and 6.1%, respectively), diarrhea (4.4% and 5.5%, respectively), and nausea (4.4% and 3.7%, respectively). CONCLUSIONS: Three-day treatment with azithromycin 500 mg once daily is equivalent to a 10-day treatment with clarithromycin 500 mg twice daily in adult patients with AECB.

Acute Disease↗
PubMedDate not supplied

A double-blind, randomized, placebo-controlled trial of n-3 versus n-6 fatty acid-based lipid infusion in atopic dermatitis.

BACKGROUND: In the involved epidermis of patients with atopic dermatitis, changes in the metabolism of eicosanoids with increased quantities of the arachidonic acid (AA)-derived lipoxygenase products have been observed. Free eicosapentaenoic acid (EPA), a fish oil-derived alternative (n-3) fatty acid, may compete with AA, resulting in an anti-inflammatory effect. METHODS: In a 10-day double-blind, randomized, placebo-controlled trial, 22 patients hospitalized for moderate-to-severe atopic dermatitis were randomly assigned to receive daily infusions of either a n-3 fatty acid-based lipid emulsion (fish oil, 10%; 200 mL/d) or a conventional n-6-lipid emulsion (soybean oil, 10%; 200 mL/d). Topical treatment was restricted to emollients. The severity of disease was evaluated daily with scoring of erythema, infiltration, and desquamation and by subjective patient scoring of clinical manifestations. In addition, plasma-free and total-bound fatty acids and the composition of membrane fatty acids in blood cells (thrombocytes, granulocytes, and erythrocytes), lipid mediators from isolated neutrophils and platelets, and lymphocyte-activation parameters were determined. RESULTS: Twenty patients completed the trial. Marked improvement from baseline was seen in both groups. On days 6, 7, 8, and 10, disease severity score-defined as the sum of all scores-was more pronounced (p < .05) in the n-3 group compared with the n-6 group. Free arachidonic acid in plasma did not change substantially in both groups, whereas plasma-free EPA, total-bound EPA, and the membrane EPA/AA ratio markedly increased in response to n-3-lipid infusion. In parallel, EPA-derived lipid mediators appeared, whereas lymphocyte functions were unaffected. In the post-treatment period (2/4 weeks), relapse was observed in some patients after n-3 psoralene-ultraviolet A (PUVA) infusion, whereas there was a marked long-term improvement in the n-6 group. CONCLUSIONS: IV n-3-fatty acid administration is effective in acutely improving the severity of atopic dermatitis, paralleled by changes in plasma and membrane fatty acid composition and lipid mediator synthesis. The long-term beneficial effects of IV n-6 fatty acids should be evaluated further.

Adolescent↗
PubMed1998

[Acute blindness due to trauma in a Welsh pony-colt].

A healthy, 10-day-old Welsh A pony colt was totally blind 1 day after arrival at a studfarm. Both eyes appeared normal on external inspection. The young animal had been very distressed during the 40-km journey to the studfarm. Intravenous corticosteroids were administered for 2 days, but did not result in any observable improvement. The animal was euthanized at the owner's request. Both eyes with the optic nerves were removed for histological examination. Both optic nerves showed Wallerian degeneration, a well-known response of peripheral nerves to trauma. The foal, which was not tethered during transportation, probably sustained a blunt trauma in the trailer. This case highlights the importance of taking adequate measures to prevent young animals from sustaining blunt trauma during transport.

Animals↗
PubMed1973

Method for assessing therapeutic potential of anti-inflammatory antirheumatic drugs in rheumatoid arthritis.

A 14-day, single-blind trial of prednisone, aspirin, and placebo was carried out in 128 patients suffering from rheumatoid arthritis, using subjective criteria only (severity of pain daily on a pain chart and assessment of the drug for effectiveness). The average treated pain rating, mean patient satisfaction rating, and mean number of days withdrawn from each drug all showed significant differences between prednisone, aspirin, and placebo. Of various pretreatment observations, only the initial pain score and articular index of joint tenderness were significantly related to the average treated pain rating.The trial method is simple and allows many patients to participate without being time consuming for patient or physician. The method seems to have potential in comparing the comparative effectiveness of anti-inflammatory analgesics used in the treatment of patients with rheumatoid arthritis.

Anti-Inflammatory Agents↗
PubMed2005

Efficacy and safety of oxymorphone extended release in chronic low back pain: results of a randomized, double-blind, placebo- and active-controlled phase III study.

UNLABELLED: This multicenter, randomized, double-blind, placebo- and active-controlled trial was conducted to compare the analgesic efficacy and safety of oxymorphone extended release (ER) with placebo and oxycodone controlled release (CR) in ambulatory patients with moderate to severe chronic low back pain requiring opioid therapy. Patients (N = 213) aged 18 to 75 years were randomized to receive oxymorphone ER (10 to 110 mg) or oxycodone CR (20 to 220 mg) every 12 hours during a 7- to 14-day dose-titration phase. Patients achieving effective analgesia at a stable opioid dose entered an 18-day double-blind treatment phase and either continued opioid therapy or received placebo. With stable dosing throughout the treatment phase, oxymorphone ER (79.4 mg/day) and oxycodone CR (155 mg/day) were superior to placebo for change from baseline in pain intensity as measured on a visual analog scale; the LS mean differences were -18.21 and 18.55 (95% CI, -25.83 to -10.58 and -26.12 to -10.98, respectively; P = .0001). Use of rescue medication was 20 mg per day. Adverse events for the active drugs were similar; the most frequent were constipation and sedation. Oxymorphone ER and oxycodone CR were generally safe and effective for controlling low back pain. Oxymorphone ER was equianalgesic to oxycodone CR at half the milligram daily dosage, with comparable safety. PERSPECTIVE: Definitive studies of long-acting opioids in patients with chronic low back pain are lacking. We report the results of a multicenter, randomized, placebo-controlled, double-blind study evaluating the analgesic efficacy and safety of oxymorphone ER and oxycodone CR in opioid-experienced patients with chronic low back pain.

Adolescent↗
PubMed1998

[Conversion from oral ACE inhibitor to intravenous quinaprilat administration in mild to moderate essential hypertension].

AIM: This study was designed to evaluate the efficacy of intravenous quinaprilat in maintaining blood pressure control and to assess the safety of directly switching from oral angiotensin-converting enzyme (ACE) inhibitors to intravenous quinaprilate. PATIENTS AND METHOD: Following an initial 1-day open-label phase, patients with essential mild to moderate hypertension controlled by ACE inhibitor monotherapy were randomly assigned to treatment with intravenous quinaprilate (n = 36) or oral quinapril (n = 19) for a 3-day double-blind period. Quinaprilate (2.5, 5, or 10 mg BID) and quinapril (10, 20, or 40 mg OD) dosages were based on the patient's previous ACE inhibitor doses. The intravenously used dosages were half the dosages of orally administered enalapril, lisinopril and quinapril. Patients returned to their previous ACE inhibitor therapy during a second 1-day open-label phase. RESULTS: Quinaprilate and quinapril maintained diastolic blood pressure control at levels comparable to those during the initial open-label ACE inhibitor treatment. The mean difference between quinaprilate and quinapril treatment groups in diastolic blood pressure showed no clinically relevant differences between treatment groups with regard to mean changes from baseline. Mean reductions in systolic blood pressure were similar to those of diastolic blood pressure. CONCLUSION: Quinaprilate, at half the dose of quinapril, administered BID maintains blood pressure control, is well tolerated, and allows for safe conversion from previously applied oral ACE inhibitors. This finding is important for the antihypertensive treatment of patients in intensive care units or peri/post-operatively who cannot swallow orally administered drugs.

Administration, Oral↗
PubMed1993

Thyroid functioning during treatment for depression.

Thirty-nine unipolar depressed patients were treated, after a washout period of seven days in a double blind study with either moclobemide, placebo or amitriptyline, for 42 days. The psychopathological assessment and HRSD were done on seven day intervals and thyroid analysis was done on 14 day intervals. At the end of therapy, the levels of T4 and fT4 decreased significantly in the responders if amitriptyline was used, and non-significantly if placebo or moclobemide were used. The T4 and fT4 values of the non-responders increased non-significantly. The weight change was minimal and non-significant.

Adult↗
PubMedDate not supplied

Efficacy of the eradication of Helicobacter pylori infection in patients with chronic urticaria. A placebo-controlled double blind study.

Helicobacter pylori has been involved in the pathogenesis of chronic idiopathic urticaria (CIU) in patients suffering both CIU and H. pylori infection. We selected 49 patients with 13C urea breath test positive, long-lasting CIU and H. pylori infection; 20 remained symptomatic, had positive urease test or H. pylori histologic identification in gastric biopsy material and accepted to participate in a pacebo-controlled treatment trial. They were randomized for a 7-day, double-blind, placebo-controlled H. pylori eradication treatment with amoxicillin, clarithromycin and omeprazol or placebo. H. pylori eradication was assessed by a second 13C urea breath test six weeks after the end of treatment. We observed a significant improvement of more than 70 % of CIU; baseline clinical score was seen in 4 of the 9 (44 %) patients who eradicated H. pylori after active treatment and in 1 of the 7 (12,3 %) of those who did not (p = 0.19). No clinical differences in CIU characteristics were found between patients with and without improvement. No serious adverse effects were observed in either treatment group. We conclude that the eradication of H. pylori may be useful for patients suffering long-lasting CIU and H. pylori infection, although theses results did not reach statistical significance probably owing to the strict conditions of the recruitment.

Adult↗
PubMed1991

The effect of aerosolized SK&F 104353-Z2 on the bronchoconstrictor effect of leukotriene D4 in asthmatics.

Leukotriene D4 (LTD4) is a potent bronchoconstrictor and vasoactive mediator that has been implicated in the pathogenesis of bronchial asthma. We have studied the effect of SK&F 104353-Z2, a specific LTD4 antagonist, on LTD4-induced bronchoconstriction in asthmatics. A total of 12 mild asthmatics (mean baseline FEV1 +/- SEM: 85.9% +/- 2.6) received on 2 separate days, double-blind and cross-over, 800 micrograms SK&F 104353-Z2 or placebo via aerosol. After 30 min, doubling concentrations of LTD4 (0.078 to 20.1 microM in the first 4 patients and up 80.4 microM in the other patients) were inhaled with intervals of 30 min. Specific airways conductance (sGaw) and forced expiratory volume in 1 s (FEV1) were measured. On the placebo-day LTD4 inhalation caused a concentration dependent bronchoconstriction. The effect of SK&F 104353-Z2 on baseline sGaw and FEV1 could be evaluated in 10 patients. After inhalation of SK&F 104353-Z2 a small, but significant increase, in sGaw (0.107 +/- 0.013 to 0.132 +/- 0.011 cm H2O-1s-1) and FEV1 (3.39 +/- 0.23 to 3.56 +/- 0.25 liter) was observed. The effect of SK&F 104353-Z2 on the dose-response curve for LTD4 was evaluated in the six patients who inhaled concentrations of LTD4 up to 80 microM. On the active treatment day, the dose-response curve for LTD4 was significantly shifted to the right.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Inhalation↗
PubMed1993

Giant craniopharyngioma with blindness reversed by surgery.

A 3-year-old boy presented with a 3-day history of total blindness. There were no features of raised intracranial pressure or endocrine disturbance. Magnetic resonance imaging of the brain showed a giant craniopharyngioma measuring 5 x 3 cm. It was located in the suprasellar region and produced a mass effect with compression of the III and both lateral ventricles. The tumour extended downwards into the pituitary fossa. Urgent surgical decompression and subtotal excision of the tumour resulted in complete visual recovery in the right eye. The left eye remained blind. The blindness might have been caused by direct pressure on the optic nerves and chiasma by the tumour. The lack of visual recovery in the left eye may be the consequence of additional ischaemic insult to the left optic nerve. It is concluded that surgical decompression should be carried out in a patient with a giant craniopharyngioma presenting with total blindness before the condition is considered hopeless.

Blindness↗
PubMed2001

Pivagabine effects on neuroendocrine responses to experimentally-induced psychological stress in humans.

Neuroendocrinology of chronic stress seems to be characterized by HPA axis hyperactivity and early childhood stressors have been hypothesized to predispose individuals to adult onset depression by means of dysregulation of the HPA axis. Pivagabine (PVG), a hydrophobic 4-aminobutyric acid derivative, has been used experimentally recently in the treatment of different disorders related to stress-maladaptation, because of its possible inhibitory action on corticotrophin releasing factor secretion and HPA axis function. In the present study, 20 healthy male subjects were each exposed twice to the same psychosocial stressor (stroop color-word interference task, public speaking and mental arithmetic in front of an audience) during a first session (day 1) and a second session (day 8). Plasma concentrations of norepinephrine (NE), epinephrine (EPI), adrenocorticotropic hormone (ACTH) and cortisol (CORT), heart rate (HR) and systolic blood pressure (SBP) were measured immediately before the beginning of the tests and at their end, 30 min later, on both experimental days. Utilizing a double blind schedule, the subjects received pivagabine (900 mg, twice a day)(PVG group: nine subjects) or placebo (PBO group: 11 subjects) during the 7 days between the two stress sessions. NE, EPI, ACTH, and CORT levels were significantly elevated after stress exposure on day 1 and day 8 in PBO group subjects. After PVG treatment, on day 8, ACTH, CORT, NE and EPI responses to stress were significantly blunted, together with HR and SBP, in PVG group subjects. These results add to the evidence concerning PVG capacity to inhibit the HPA axis in humans, in response to stressful stimuli, and suggest that the action of PVG may be mediated not only by GABAergic receptors, but also by the suppression of catecholamines response. PVG treatment could modulate HPA hyper-responsiveness to stress in subjects with negative affectivity and depressive traits.

Adrenocorticotropic Hormone↗
PubMed2005

The postoperative analgesic effects of intra-articular levobupivacaine in elective day-case arthroscopy of the knee: a prospective, randomized, double-blind clinical study.

PURPOSE: Pain and emesis are the two major complaints after day surgery. Local anesthesia has become an important part of optimizing perioperative pain treatment. The aim of the present study was to study two different concentrations of levobupivacaine's effect on postoperative pain following elective arthroscopy of the knee with lidocaine 10 mg/ml with adrenaline as active control. TYPE OF STUDY: Prospective, randomized double-blind study with lidocaine as active control but without placebo. METHODS: One hundred and twenty patients were studied comparing levobupivacaine 2.5 mg/ml, levobupivacaine 5 mg/ml, and lidocaine 10 mg/ml with adrenaline given intra-articularly at the end of day-case operative elective arthroscopy of the knee done in light general anesthesia. Primary study endpoint was the need for any analgesics during the first 24 postoperative hours. RESULTS: Levobupivacaine 5 mg/ml was associated with a reduced need for any analgesia during the entire 24-h study period (p = 0.013) as compared to both 2.5 mg/ml levobupivacaine and lidocaine with adrenaline. Levobupivacine 2.5 mg/ml was inferior to lidocaine with regard to pain relief with an increase in need for oral analgesia already during stay in the recovery unit (p < 0.001). CONCLUSIONS: Levobupivacaine 5 mg/ml was found to be an effective local anesthetic in day-case operative arthroscopy of the knee providing superior postoperative analgesia as compared to lidocaine with adrenaline or a lower concentration of levobupivacaine. LEVEL OF EVIDENCE: Level I: Prospective, randomized double-blind study without placebo.

Ambulatory Care↗