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Biomedical subjects

C M Gruber

Publications and source records attributed to C M Gruber.

At least 19 recordsLinked to original sources
PubMed1987

Enteric coating of fenoprofen calcium reduces gastrointestinal microbleeding.

The effects of plain and enteric-coated fenoprofen calcium (Nalfon, Dista, Indianapolis, Ind.) on gastrointestinal microbleeding were studied in 32 normal male volunteers in a randomized, open-label, parallel trial at two inpatient research facilities. A 1-week placebo (baseline) period preceded 2 weeks of fenoprofen therapy (enteric coated or plain, 600 mg q.i.d.). Fecal blood loss was measured by 51Cr-tagged erythrocyte assay and averaged over days 4 to 7 (baseline) and 11 to 14 and 18 to 21 (active therapy). At one center gastrointestinal irritation was evaluated endoscopically before and after active therapy. Endoscopy showed both formulations to cause mucosal damage not evident by subject-reported symptoms. Four of the 16 subjects developed asymptomatic duodenal ulcers. Mean daily fecal blood loss was significantly lower (P = 0.03) with enteric-coated (mean +/- SD, 1.104 +/- 0.961 ml/day) than with plain fenoprofen calcium (mean +/- SD, 1.686 +/- 0.858 ml/day), suggesting that tolerance of fenoprofen can be improved with administration in an enteric-coated form.

Adult↗
PubMed1985

Dose response to fenoprofen calcium using placebo and codeine as controls.

This paper evaluates the dose-response relationship of several doses of fenoprofen calcium, between 12.5 and 300 mg, and their relationship to 60 mg of codeine sulfate and placebo. Three separate parallel studies are included in this evaluation, including a total of 867 patients. The types of pain were cesarean section, episiotomy wound, uterine cramping, and general surgery. This paper shows that a significant increasing relationship exists between efficacy and dose of fenoprofen, suggesting that relatively larger doses of fenoprofen will achieve greater amounts of efficacy.

Cesarean Section↗
PubMed1983

Comparison of fenoprofen calcium, ibuprofen and placebo in primary dysmenorrhea.

This prospective, double-blind, parallel, two clinic study compared fenoprofen calcium, 200 mg; ibuprofen, 400 mg; and placebo in the treatment of pain due to primary dysmenorrhea. By various criteria, the treatment groups, prior to treatment, were not significantly different (P greater than 0.05) in paired comparisons. However, after oral administration of the study medications, the pain scores were significantly greater (P less than 0.05) for the placebo group than for either other group. The posttreatment pain scores for the fenoprofen and ibuprofen treated groups were not significantly different (P greater than 0.05).

Clinical Trials as Topic↗
PubMed1983

Pharmacokinetics and relative potency assays with analgesic medications.

Simulated pharmacokinetic data are used to depict how single-dose relative potency assays fail when medications with half-lives of 3, 6, 12, and 24 hours are compared. When doses are given every six hours, the steady-state maximum concentrations (as a percent of the first dose Cmax) are respectively 133, 199, 377, and 598. Conversely, the sums of the maximum and minimum concentrations following the first dose, as percent of the steady-state Cmax plus Cmin are respectively 75, 50, 30, and 17. Single-dose comparisons among usual (maintenance) doses of analgesics with different half-lives (accumulation characteristics) do not provide satisfactory estimates of relative therapeutic efficacy.

Absorption↗
PubMed1979

A multicenter study for analgesia involving fenoprofen, propoxyphene [alone or in combination] with placebo and aspirin controls in postpartum pain.

One investigator at each of 4 institutions followed the requirements of a core protocol designed to evaluate propoxyphene napsylate (50, 100 and 150 mg), fenoprofen calcium (200, 400 and 600 mg) and their combination (50/200, 100/400 and 150/600 mg) in patients reporting postpartum pain. Placebo and aspirin (650 mg) were included as control medications. Analyses were based on subgrouping which isolated individually the interactions between medications and the following factors: dose-observation criteria, the investigator-observer-institution differences, the intensity of pain at the time the medication was given, and postepisiotomy-wound compared to uterine-cramp pain. Each of these factors influenced the absolute scores for analgesia significantly, but had no significant influence on the relative rankings of the medications. The analgesia scores for individual patients in each subgroup were transformed to ridits and then pooled. A linear increase in effectiveness occurred in response to increasing doses of propoxyphene, fenoprofen, and their combination in this dose range. The dose responses were essentially parallel. The combination was more effective than either drug alone.

Analgesia↗
PubMed1977

Codeine and propoxyphene in postepisiotomy pain. A two-dose evaluation.

In a double-blind control study, oral doses of placebo, propoxyphene napsylate (50 or 100 mg), or codeine sulfate (30 or 60 mg) were administered to 46 postepisiotomy patients, grouped by severity of pain reported at first-dose drug administration. Eight hourly observations by a trained observer provided estimates of analgesia. The analgesia scores for placebo treatments were significantly lower than for the lesser doses of either drug (P less than .05) as well as for the greater doses (P less than .01). At both dose levels, the analgesia scores for both drugs were almost identical. Analgesia with the higher doses was greater than with the lower, but not to a statistically significant extent. The difference in patient responses increased following the second dose. No serious adverse reactions occurred; the elicited and volunteered reports of minor side effects were similar for all five treatments.

Clinical Trials as Topic↗
PubMed1977

Dose response to fenoprofen in an antipyretic study of fenoprofen and propoxyphene.

Single oral doses of 0, 50, 100, and 200 mg (acid equivalents) of fenoprofen calcium provide essentially linear increases in antipyretic activity over a six-hour period in patients with fever due to acute upper respiratory tract infection. During this same time interval, 200 and 400 mg doses apparently had equal efficacy. Single oral doses of 200 and 400 mg propoxyphene napsylate had no significant effect on the fever of patients with acute respiratory tract infections. No significant interaction between propoxyphene and fenoprofen, related to the antipyretic effect of fenoprofen, was demonstrated.

Administration, Oral↗
PubMed1977

A multicenter analgesic study using single doses of placebo, propoxyphene and acetaminophen.

Six studies were conducted using identical protocols. The design involved single oral doses of placebo, propoxyphene, acetaminophen and a combination of the two drugs. Postpartum patients with either postepisiotomy or uterine cramp pain participated. Both efficacy and adverse reports were evaluated. The differences among medications were consistently less than one standard deviation from the mean for the studies indicating a lack of sensitivity to drug effects. In order of increasing effectiveness based on the pooled data, the medications were placebo, propoxyphene, acetaminophen, and the combination.

Acetaminophen↗
PubMed1976

Clinical pharmacology of fenoprofen: a review.

This review summarizes available data concerning fenoprofen. The pharmacodynamics, in vivo interactions, gastrointestinal microbleeding, screening for anti-inflammatory action, and tests for antipyretic and analgesic efficacy are discussed.

Animals↗
PubMed1976

Analgesia, plasma levels, and dosage of propoxyphene.

It can be shown that both the mean plasma levels observed and the mean analgesic scores (effectiveness) are related to the dose of an orally effective analgesic agent, although wide individual variations exist. Based on the pharmacokinetic characteristics of propoxyphene, it can be predicted and confirmed that equilibrium (or steady state) plasma levels will be achieved after about six doses when administered on a q. 6h. schedule. Similar predictions indicate that an initial loading dose of 2 to 2 1/2 times the maintenance dose will produce more promptly plasma levels within or close to the equilibrium levels.

Analgesia↗
PubMed1975

Determination of propoxyphene and norpropoxyphene by chemical ionization mass fragmentography.

The kinetics of propoxyphene and its primary metabolite, norpropoxyphene, have been simultaneously re-evaluated in man by using gas-liquid chromatography/mass spectrometry, deuterium-labeled mass internal standards, and multiple ion monitoring. Plasma concentrations in 4 volunteers determined for as long as 240 hr after single oral doses of 2 propoxyphene salts indicate the overall half-life of propoxyphene to be 11.8 hr and of norpropoxyphene to be 36.6 hr.

Adult↗
PubMed1975

Problems and solutions to single-dose testing of analgesics: comparison of propoxyphene, codeine, and fenoprofen.

Discrepancies exist between reports arising from single-dose and multiple-dose studies intended to compare the efficacy of oral analgesics. D Differences in the pharmacokinetic characteristics of these drugs account for much of the discord. Codeine and fenoprofen rapidly achieve their ultimate plasma equilibrium levels (on a q. 6h. schedule), whereas, propoxyphene requires a longer period, doubtless due to its longer half-life and proportionately smaller maintenance dose. If the drugs are not to be compared during the steady state, then administration of appropriate loading doses permits satisfactory single dose comparisons at steady-state concentrations.

Analgesics↗