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Biomedical subjects

R E Pyke

Publications and source records attributed to R E Pyke.

16 recordsLinked to original sources
PubMed1996

Analgesic efficacy of the kappa-receptor agonist, enadoline, in dental surgery pain.

To study the analgesic efficacy of enadoline, a selective agonist of the kappa-opioid receptor, a double-blind, randomized comparison was made of enadoline versus placebo and a combination of acetaminophen-codeine in patients with pain after surgical extraction of impacted molar teeth. An initial study involving a comparison of enadoline, a combination, and placebo failed to show any analgesic effect of enadoline. Therefore, a second study with the same design but using higher doses of enadoline was conducted. Despite continued safety and tolerability even at the higher doses, enadoline could not be shown to be superior to placebo. The acetaminophen-codeine combination was significantly more effective than enadoline or placebo. Enadoline did not show analgesic efficacy in this study. Possible reasons for this lack of efficacy are discussed.

Acetaminophen↗
PubMed1996

Analgesic efficacy of enadoline versus placebo or morphine in postsurgical pain.

Enadoline, a selective agonist of the kappa-opioid receptor, was studied for its analgesic efficacy in patients with pain after obstetric or gynecologic surgery. An initial study involving a comparison of enadoline (2, 5, 15 micrograms), an acetaminophen-codeine (ACET/COD) combination, and placebo showed all treatments to be ineffective analgesics. Therefore, a second study with the same design but using higher doses of enadoline (15 and 25 micrograms) and replacing ACET/COD with morphine 10 mg i.m. was conducted. Enadoline 25 micrograms produced similar pain relief to that of morphine, although of shorter duration, and better than enadoline 15 micrograms or placebo. However, enadoline was associated with dose-limiting neuropsychiatric adverse events, which led to early termination of the study.

Abdomen↗
PubMed1995

A double-blind, placebo-controlled study of a CCK-B receptor antagonist, CI-988, in patients with generalized anxiety disorder.

This multicenter, double-blind, placebo-controlled, parallel-group, randomized study assessed the efficacy, safety, and tolerability of a novel CCK-B antagonist CI-988 in the treatment of generalized anxiety disorder (GAD). Patients received placebo or CI-988 (300 mg/day, thrice daily) for 4 weeks. Patients with a primary diagnosis of GAD according to DSM-III-R criteria were randomized. The study design included a 1- to 2-week single-blind placebo baseline phase, followed by a 4-week double-blind treatment phase. Efficacy was measured weekly by Hamilton Rating Scale for Anxiety (HAM-A), Clinical Global Impressions of Severity and Change, UCLA-Multi Dimensional Anxiety Scale, and Hamilton Rating Scale for Depression. Patients were also evaluated to determine whether they met criteria for irritable bowel syndrome (IBS) at screening and were evaluated with a gastrointestinal visual analog scale at each visit. Eighty-eight patients were randomized to CI-988 (N = 45) and placebo (N = 43) at three centers. CI-988 did not demonstrate an anxiolytic effect superior to placebo in this clinical trial. There was no significant difference in mean change in HAM-A total between placebo (-7.73) and CI-988 (-8.64). However, a significant treatment-by-center interaction and a highly variable placebo response rate among the three centers limit the interpretation of the results. CI-988 did not have an effect on symptoms of IBS other than diarrhea, which worsened in patients with IBS. Other than a higher incidence of some gastrointestinal symptoms (diarrhea, dyspepsia, flatulence, and nausea), CI-988 was well tolerated. Results suggest that testing higher oral doses of CI-988 may be warranted.

Adult↗
PubMed1989

Double-blind comparison of alprazolam and adinazolam for panic and phobic disorders.

Subjects primarily suffering from DSM-III panic disorders (agoraphobia with panic attacks, 13 subjects; panic disorder, one subject) were tested with two drug treatments after a baseline was established using single-blind placebo capsules three times daily for 1 week. Double-blind, 4-week crossover treatments were given with alprazolam, 0.5-6.0 mg/day, and adinazolam mesylate, 10-120 mg/day. Mean final doses in mg/day were 3.1 for alprazolam and 95.5 for adinazolam mesylate. Both were broadly effective in comparison with the baseline condition. Measures included self-rated symptoms and global impressions, physician-rated global impressions, and two forms of challenges, agoraphobic and noradrenergic. The two active drugs were highly similar in overall efficacy across the sample, but alprazolam was favored globally in six subjects, and adinazolam was favored globally in another six subjects. Only two subjects obtained maximal improvement ratings without side effects with both drugs. No diagnostic or demographic factor correlated with the differential in responses to the two active treatments. No clinically significant laboratory abnormalities occurred with either drug.

Adult↗
PubMed1988

Adinazolam mesylate and placebo in depressed outpatients: a 6-week, double-blind comparison.

In 72 outpatients with DSM-III major depressive episode, adinazolam was superior to placebo in all measurements. Significantly more adinazolam-treated subjects (N = 36) than placebo subjects (N = 36) completed the study (67% vs. 19%), were rated "much" or "very much" improved (78% vs. 19%), and had a "moderate" or "marked" therapeutic effect of the drug (67% vs. 19%). The total Hamilton Rating Scale for Depression score decreased by 50% or more in 61% of the adinazolam group and in 17% of the placebo group; 72% of the adinazolam group reported that they felt "moderately," "much," or "very much" improved compared with 17% of the placebo group. The adinazolam group reported significantly more drowsiness and lightheadedness, dizziness, or faintness; the severity of these side effects decreased with time. No significant anticholinergic effects were observed.

Adult↗
PubMed1988

Alprazolam in the treatment of panic attack patients with and without major depression.

Sixteen patients with panic attacks were treated with alprazolam at an anxiety clinic between March 1982 and April 1983. For all patients charts were reviewed for baseline data and treatment results at 1 and 6 months. Quantitated self-rating scales and the Clinical Global Impressions scale were used to assess progress. Alprazolam appeared effective for panic, agoraphobia, and depressive symptoms in 7 of 11 patients with either panic disorder or agoraphobia with panic attacks (DSM-III-defined diagnoses); side effects occurred in 4 of the 11 patients, were limited to oversedation, and resulted in no discontinuations of drug. However, alprazolam was ineffective in controlling panic, agoraphobia, and depression in 5 patients with panic attacks and secondary major depressive episode; for this group of patients, side effects were apparently paradoxical and required drug discontinuation in 3 of these 5 patients.

Adult↗
PubMed1986

Norepinephrine challenges in panic patients.

Six subjects with agoraphobia with panic attacks were pretreated with placebo and restricted use of lorazepam for 4 or 5 days. Then l-norepinephrine was infused intravenously with stepwise increases to 4 to 16 micrograms/min. All subjects developed DSM-III symptoms of a panic attack. Subjective results including idiosyncratic symptoms closely resembled the spontaneous panic attacks of these subjects. Cardiac rhythm and rate changes contradicted subjective reports of racing heart and palpitations. Tachypneic and hypertensive reactivities were benign. Both anxiety symptoms and cardiovascular changes reversed rapidly and spontaneously upon discontinuation of the infusion. To validate the possibility that norepinephrine infusion may specifically and reliably simulate spontaneous panic attacks, the authors recommend further work, particularly blinded controlled studies.

Adult↗