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At least 721 records · Page 40Linked to original sources
PubMed1989

Double-blind multicenter controlled clinical study comparing the efficacy of picumast dihydrochloride versus astemizole and placebo in patients with seasonal allergic rhinitis.

The efficacy of picumast dihydrochloride (3,4-dimethyl-7-[ 4-(4-chlorobenzyl)piperazine-1-yl]propoxycoumarine dihydrochloride) in a dosage of 2 mg o.d. vs. astemizole (10 mg o.d.) and placebo was investigated in a double-blind, controlled multicenter study. During the first 3 days of treatment, the patients were administered double their assigned dose as loading dose. A total of 119 patients were enrolled in the study, of whom 103 were evaluable for efficacy (picumast dihydrochloride n = 35, astemizole n = 35 and placebo n = 33). The primary objective was the number of patients for whom the investigator scored the effectiveness of study medication as adequate or better over a treatment period lasting at least 4 days. A statistically significantly improved efficacy over placebo was demonstrated by picumast dihydrochloride in terms of the primary objective as was a trend to improved efficacy over astemizole. Observation of the length of participation of the patients in the study up to the point of premature stopping due to inadequate efficacy, adverse events or non-compliance demonstrated that clearly more patients in both active drug groups remained in the study over the planned duration of 28 days compared with patients in the placebo group. In this respect, more patients on astemizole dropped out of the study prematurely compared with patients on picumast dihydrochloride. Serious adverse events did not occur.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1989

[Multicenter research on cefoperazone efficacy and tolerance in the therapy of urinary and respiratory infections].

In this multicenter study the authors evaluated the clinical and microbiological efficacy and the local and general safety of cefoperazone sodium in 1,546 patients (946 males and 600 females, mean age 61.3 years) with lower respiratory tract (1,044) and urinary tract (539) infections. Results were very encouraging with 95.3% of clinical cures or improvement, 91.6% of microbiological eradication, and a local and general safety which was always extremely high, i.e. 96.9% and 98.3% respectively.

Adolescent↗
PubMed1989

Clinical experience with ciprofloxacin: analysis of a multicenter study.

In a multicenter study of 128 patients treated with ciprofloxacin (mean daily dosage, 982 mg per day; mean duration of treatment, 8.9 days) for a variety of infections, 48 were microbiologically proven. Of these, bacteriologic cure and/or improvement resulted in 93% of cases. For all 128 infections clinical cure and/or improvement resulted in 93.8% of cases. Twenty-nine (23.8%) of all infections were classified as chronic. Overall, there were 3/128 (2.3%) adverse reactions (ADRs); one case each of diarrhea, malaise, and nausea/vomiting. None were related definitely to ciprofloxacin therapy. Therapy with ciprofloxacin was discontinued in two (1.6%) of 128 patients because of adverse gastrointestinal (GI) effects. One patient elected to continue ciprofloxacin therapy despite mild GI side effects.

Adolescent↗
PubMed1989

A multicenter therapeutic study of 1100 children with brucellosis.

A 6-year multicenter therapeutic study was performed on 1100 children with brucellosis in order to compare several antibiotic combinations and duration of treatment. The patients were randomized to receive oral therapy with oxytetracycline, doxycycline, rifampin and trimethoprim-sulfamethoxazole (TMP/SMX) either alone or in combination with each other or combined with streptomycin or gentamicin injections. The patients were also randomized into three groups based on the duration of oral therapy: 500 patients were treated for 3 weeks; 350 for 5 weeks; and 250 for 8 weeks. When intramuscular aminoglycosides were used, streptomycin was given for 2 weeks and gentamicin for 5 days. In oral monotherapy oxytetracycline, doxycycline and rifampin showed comparable results with low relapse rates (less than or equal to 9%) and no statistically significant differences were found among 3-, 5- or 8-week durations of therapy. TMP/SMX alone showed an unacceptably high relapse rate (30%) with all durations of therapy. In combined oral therapy rifampin plus oxytetracycline, rifampin plus TMP/SMX and oxytetracycline plus TMP/SMX showed comparable results with low relapse rates ranging from 4 to 8% in patients receiving therapy for 3 or 5 weeks, no relapses occurred in patients treated for 8 weeks. When oral monotherapy was combined with either streptomycin or gentamicin, very few relapses were seen, irrespective of the duration of treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗
PubMed1989

OM-8980 in rheumatoid arthritis: a 6-month double blind placebo controlled multicenter study.

A new immunomodulating drug, OM-8980, was compared to placebo in a 6-month double blind multicenter trial including 107 patients with active rheumatoid arthritis. Ritchie index, number of swollen joints and the pain scale improved significantly more with OM-8980 than with placebo. Grip strength, duration of morning stiffness and erythrocyte sedimentation rate improved more markedly with OM-8980 than with placebo, but the difference did not reach statistical significance. The use of analgesic and antiinflammatory drugs diminished significantly more with OM-8980 than with placebo. Clinical tolerance was good with 7 side effects reported in 3 of the 52 patients included in the OM-8980 group and 11 in 8 patients of the 55 in the placebo group (mostly gastrointestinal troubles and skin reactions). In the overall evaluation by both patients and physicians OM-8980 was significantly superior to placebo.

Arthritis, Rheumatoid↗
PubMed1989

Does the acetyl group of aspirin contribute to the antiinflammatory efficacy of salicylic acid in the treatment of rheumatoid arthritis? The Multicenter Salsalate/Aspirin Comparison Study Group.

In a multicenter, double blind, parallel group study, 233 patients with classical or definite rheumatoid arthritis (RA) were randomized to 12 weeks of either salsalate (salicylsalicylic acid, nonacetylated salicylate) or aspirin following disease flare. One hundred-fifty patients completed, 83 taking salsalate and 67 taking aspirin. Patients received initial doses of 3 g/day of salsalate or 3.6 g/day of aspirin. Doses were adjusted during the first 5 weeks for efficacy and tolerance. Both treatments were equally effective as measured by all the usual variables, but there was a higher incidence of severe gastrointestinal problems among patients taking aspirin. Thus, this study demonstrated that the acetyl group of aspirin does not enhance the antiinflammatory efficacy of salicylic acid in RA.

Acetylation↗
PubMed1989

Clinical experience with ciprofloxacin: analysis of a multicenter study.

The authors report a multicenter study of 19 patients treated with ciprofloxacin (mean daily dosage, 972 mg per day; mean duration of treatment, 8.5 days) for a variety of infections, ten microbiologically proven. Of these, bacteriologic cure equaled 70%, and improvement 30%. Overall, clinical cure equaled 73.7%, while improvement was 15.8%. No infections were classified as chronic. One adverse reaction was noted; a case of severe vomiting classified as related definitely to ciprofloxacin therapy. The patient discontinued therapy.

Adolescent↗
PubMed1989

Low incidence of thrombocytopenia with porcine mucosal heparin. A prospective multicenter study.

We treated 193 patients either intravenously (94) or subcutaneously (99) for at least 5 days with porcine intestinal mucosal heparin and followed them up prospectively with frequent platelet counts to determine the incidence of heparin-related thrombocytopenia and arterial thrombosis. None of the patients in the study developed severe thrombocytopenia (platelet count, less than 100 x 10(9)/L) or arterial thrombosis. Eight patients had a platelet count of 100 to 140 X 10(9)/L on one occasion, with a count of greater than 140 x 10(9)/L on the subsequent measurement. The mean (+/- SD) values of the initial and lowest platelet counts during therapy in all patients were 288 +/- 100 x 10(9)/L and 253 +/- 88 x 10(9)/L, respectively, with the lowest counts occurring on day 4.1 +/- 4.2. A least-squares line was computed for each patient to fit the day and counts; the slopes were significantly different from zero and negative in 7.8% of patients and positive in 14.5%. This multicenter study confirms the reports that the incidence of heparin-related severe thrombocytopenia and arterial thrombosis is distinctly low in patients treated with porcine-mucosal heparin.

Aged↗
PubMed1989

[Semeiology of intestinal infarction. Multicenter prospective study].

A multicenter study was conducted prospectively in 6,970 consecutive adult patients with acute abdominal pain lasting less than 7 days. Seventy-one (1 p. 100) had an intestinal infarction. Sensitivity and positive predictive value, for a 1 p. 100 prevalence, were computed for each one of 43 clinical, biological and radiologic signs. According to these indexes, signs were classified as "not worthwhile", "passable", "adequate", "good", or "excellent". No sign was found to be "excellent"; this may account for the difficulty of intestinal infarction diagnosis in the emergency setting. Moreover, signs generally described as "worthwhile" for the diagnosis (accurate description of initial pain, failure to pass feces, abdominal tenderness, guarding, murmur) were found to be "not worthwhile". "Good" signs included recent arrhythmia, low blood pressure, stasis fluid in gastric aspirate, and diffuse opacity on X-ray films.

Abdomen, Acute↗
PubMed1989

Sultamicillin versus amoxicillin in the treatment of tonsillitis and pharyngitis: a European multicenter study.

In this multicenter open, comparative study, 135 patients were treated with sultamicillin (67 subjects; 500 mg every 12 h) or amoxicillin (68 subjects; 500 mg every 8 h) for 10 d. Of the pathogens isolated pre-treatment, 24 of 29 (including 4 of 6 resistant strains) in the sultamicillin group were eradicated at the end of treatment, as were 17 of 22 in the amoxicillin group. At follow-up, the figures were 17 of 25 and 16 of 19, respectively. Clinical success was achieved in 55 of 55 sultamicillin and 40 of 43 amoxicillin patients at the end of treatment, and in 40 of 42 and 29 of 31, respectively, at follow-up. Overall success was recorded in 20 of 25 and 15 of 23 sultamicillin, and 14 of 19 and 13 of 17 amoxicillin patients at the two assessments. Side effects were reported for 21 sultamicillin patients, 1 of whom withdrew because of diarrhea, and 15 amoxicillin patients, 4 of whom withdrew because of rash. One sultamicillin and 4 amoxicillin patients developed minor abnormalities in laboratory safety parameters.

Adolescent↗
PubMed1989

A multicenter, randomized, double-blind study comparing once-daily bedtime administration of famotidine and ranitidine in the short-term treatment of active duodenal ulcer.

The efficacy and safety of famotidine and ranitidine in the treatment of active duodenal ulcer were compared in a multicenter, randomized double-blind study. The study was carried out at 5 centers and involved a total of 143 patients with endoscopically documented active duodenal ulcer. The patients received either famotidine (1 40 mg tablet at night) or ranitidine 2 150 mg tablets at night). Endoscopic examinations were performed at 4 and 6 weeks of active treatment. Day and nocturnal pain were also monitored, and the laboratory and clinical profiles evaluated. One hundred and thirty-three patients fulfilled the evaluation criteria (66 patients in the famotidine group and 67 in the ranitidine group). Healing rates at weeks 4 or 6 of treatment showed no significant differences between the famotidine group and the ranitidine group. The healing rates were 78% at week 4 and 96% at week 6 in the famotidine group, and 76% at week 4 and 95% at week 6 in the ranitidine group. Similar results were observed in both treatment groups with regard to pain resolution, decrease in antacid intake and safety profile.

Adult↗
PubMedDate not supplied

[Treatment of duodenal ulcer with famotidine. (Multicenter study)].

A multicenter open study aimed at evaluating the effect of famotidine in the treatment of duodenal ulcer was performed in several institutions located in 15 different cities of Mexico. One-hundred-and-fourteen patients with duodenal ulcer demonstrated by endoscopy were given 40 mg. of famotidine daily, administered as a single dose at night. After 4 and 6 weeks of treatment, healing of the ulcer was observed in 81.6% and 95.6% of patients, respectively. Side-effects were very unusual. In only one patient, who experienced vertigo during the treatment, administration of the drug had to be stopped.

Adolescent↗
PubMed1989

[A multicenter study of defibrotide in the prevention of deep venous thrombosis. Final results].

In an open multicenter comparative study aimed at the evaluation of the efficacy of defibrotide and calcium heparin in the prophylaxis of postoperative deep vein thrombosis (DVT) and pulmonary embolism (PE) an evaluation has been made on 4810 patients. 2810 patients received defibrotide (800 mg/die: 400 mg b.i.d. or 200 mg q.i.d. by IV route); 2000 patients received calcium heparin (500 IU b.i.d. or t.i.d. by SC route) till the 7th post-operative day. The diagnosis of DVT or pulmonary embolism (PE) was made according to clinical routine criteria. The incidence of DVT has been 33/2810 (1.17%) in the defibrotide group and 47/2000 (2.35%) in the heparin group (chi 2 p = 0.002), while the cases of suspected or ascertained PE have been respectively 15/2810 (0.53%) and 23/2000 (1.15%) (p = 0.025). The post-operative course was totally normal in both groups; no significant adverse reactions were noticed. The obtained results suggest the effectiveness of defibrotide as an alternative to heparin in the prevention of post-operative DVT.

Adult↗
PubMed1989

Preliminary results from a multicenter trial of clomipramine in obsessive-compulsive disorder.

Two multicenter, double-blind, placebo-controlled clinical trials were conducted to evaluate the effectiveness of 10 weeks of treatment with up to 300 mg daily of clomipramine in nondepressed patients with OCD. There were 575 patients enrolled in these clinical trials, and preliminary analyses of data from 384 of these patients demonstrate a virtual absence of placebo response, a very low rate of premature discontinuation, and for patients receiving clomipramine, a statistically and clinically significant improvement in OCD symptoms (40%-45% mean improvement with clomipramine vs. 4%-5% mean improvement with placebo). In general, clomipramine was well tolerated in doses of up to 300 mg daily.

Clinical Trials as Topic↗
PubMed1989

[Randomized multicenter trial of sequential methotrexate and 5-fluorouracil versus 5-fluorouracil alone in advanced gastric cancer].

In a recent phase II trial we have shown a favorable response rate for sequential methotrexate-5-fluorouracil (MF) in advanced gastric and colorectal cancer. We determined the therapeutic effect of sequential MF in patients with advanced gastric cancer by comparing it to 5-fluorouracil alone (F) in a randomized multicenter trial. Since February 1987 to July 1988, 133 patients with advanced gastric cancer have been prospectively randomized to receive either MF (methotrexate 100 mg/m2 i.v. push, 5-fluorouracil 600 mg/m2 i.v. drip over 15 minutes one hour after methotrexate and leucovorin 15 mg p.o. q 6 hrs x 2 beginning 24 hrs after methotrexate) of F (the same 5-fluorouracil as described for MF). Each treatment was repeated weekly x 5, then q 2 weeks. The two treatment arms were balanced for 17 clinical characteristics. The response rate was 17.9% (10 of 56 patients) in the MF arm and 1.9% (one of 53 patients) in the F arm (p less than 0.01). Median duration of response was 6.8 weeks (MF) and 6 weeks (F), respectively. Median survival time was 7.9 months (MF) and 7.3 months (F) on interim findings. Leukocytopenia and GI toxicity were significantly more common in patients receiving MF, but the degree was similar for both arms. Other side effects were minimal and no different. This schedule of MF is more effective than F in inducing remission for patients with advanced gastric cancer.

Adult↗
PubMed1989

[Cumulative pharmacokinetics and clinical effects of nalbuphine in patients in the postoperative phase. An open multicenter study].

Pharmacokinetic data and analgetic potency of nalbuphine hydrochloride (Nubain) under conditions of postoperative respiratory treatment and repeated dosage was investigated in a multicenter study. Patients received 20 mg nalbuphine intravenously at intervals of 3 h. Blood samples for analysis of nalbuphine plasma concentration were taken after the first injection, immediately before further medication and after the last one. Data were fitted to 2-compartment model using non-linear fit procedures. The half-life time in plasma was slightly shorter than in other studies, while the peak plasma concentrations were comparable with other results in the literature. There was no cumulation of the substance found in this study. Clinically the antagonistic effect of nalbuphine was mainly observed after neuroleptic anaesthesia. In these cases additional injections of further analgetic and sedative drugs were necessary. The clinical effect was mostly considered to be good or satisfactory. Less satisfactory effects were due to the 3 h time distance between repeated dosage. Shorter intervals could be discussed and used because of the absence of cumulation of nalbuphine in this study.

Adolescent↗
PubMed1989

[Efficacy of injectable ofloxacin in treating septicemia. Multicenter study].

To evaluate the efficacy and safety of parenteral ofloxacin in the treatment of septicemia, a multicenter study was carried out in 88 patients, 53 men and 35 women, hospitalized either in intensive care units (41 patients) or in medical wards (47 patients). Ofloxacin was administered at a dose of 200 mg every 12 hours for a mean duration of ten days. Ofloxacin was administered as single agent to 62 patients. A clinical cure was obtained in 81 patients. Death occurred in 3 cases, relapse in 2, superinfection in one, and persistence of the infecting organism in another case (with acquired resistance to ofloxacin). 89 of the 94 isolated organisms (75% Gram negative-bacilli and 20% staphylococci) were eradicated. The adverse effects were rare, mild or moderate in severity, and always reversible. We conclude that I.V. ofloxacin is efficacious and safe in the treatment of septicemia due to Gram-negative bacilli or staphylococci.

Adolescent↗
PubMed1989

Clinical experience with ciprofloxacin: analysis of a multicenter study.

In a multicenter study of 36 patients treated with ciprofloxacin (mean daily dosage, 986 mg per day; mean duration of treatment, 10.8 days) for a variety of infections, 32 were microbiologically proven. Of these, bacteriologic cure and/or improvement resulted in 100% of cases. For all 36 infections clinical cure and/or improvement resulted in 97.1% of cases. A total of 13 infections were classified as chronic. Overall there were six adverse reactions reported in 4/36 (11.1%) patients. Five were considered related definitely to ciprofloxacin therapy, one was not. Therapy with ciprofloxacin was discontinued in two patients (5.5%). Two patients elected to continue ciprofloxacin therapy despite mild side effects.

Adolescent↗