Arzneimittel Forsch
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Arzneimittel Forsch · Jan 1985
Randomized Controlled Trial Clinical Trial Controlled Clinical Trial[Flupirtine in patients with cancer pain].
In a double-blind clinical trial the analgesic efficacy and safety of ethyl-N-(2-amino-6-[4-fluorophenyl-methylamino] pyridin-3-yl)carbamate (flupirtine, designated trademark: Katadolon) as 100-mg capsules were compared to pentazocine capsules 50 mg in 52 patients with severe to very severe cancer pain. The duration of treatment was up to one week, the daily dose up to 6 capsules. The analgesic effect was assessed by a 4-point verbal rating scale. ⋯ Final evaluation demonstrated that flupirtine was significantly more effective than pentazocine in reducing pain. The incidence of side-effects was similar in both treatment groups, flupirtine, however, caused less intensive and less clinically relevant adverse reactions. In conclusion the results indicate that flupirtine is a potent and well tolerated analgesic in the treatment of cancer pain.
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Arzneimittel Forsch · Jan 1985
Randomized Controlled Trial Comparative Study Clinical TrialClinically controlled comparative study of suprofen, pentazocine, and placebo. Experience with intramuscular single doses.
Analgesic effect and tolerability of alpha-methyl-4-(2-thienylcarbonyl)-phenylacetic acid (suprofen, Suprol) 200 mg were compared with pentazocine 30 mg and placebo in 88 patients in moderate to severe postoperative pain. The trial was designed as a randomized single-blind study; the test drugs were in single doses (1 ml ampuls) administered by deep intragluteal injection in the upper outer quadrant. The test population was homogeneous as to anamnestic data; the initial intensity of pain was comparable in all three groups. ⋯ Systemic tolerability was considered good to very good in 97% of the subjects in all three treatment groups, whereas local tolerability was considered poor in 2 patients (6.9%) in the group on suprofen. There were no significant differences between the medications. Two subjects each on suprofen and pentazocine and 1 patient on placebo experienced side effects.
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Arzneimittel Forsch · Jan 1985
Clinical Trial Controlled Clinical TrialLong-term effect of etilefrine pivalate on blood pressure in man.
An open and a placebo-controlled double-blind trial were carried out to measure the effect of a long-term treatment (2-6 months) with etilefrine pivalate (K 30 052, Ep) on blood pressure of 60 patients suffering from orthostatic dysregulation. Oral administration of the agent took place once daily, each dose containing 20 mg. While the acute response to a single dose was comparatively weak, long-term administration had a marked and long-lasting effect both on systolic blood pressure (+40.3 mmHg) and blood pressure amplitude (+37.5 mmHg) (p less than 0.01). ⋯ The increase in blood pressure amplitude points to an augmentation of stroke volume, whereas heart rate was virtually unaltered. Peripheral resistance appears not to be increased since diastolic pressure was unchanged. The elevation in blood pressure amplitude was fully reversible within 9 weeks of wash-out, thus hinting at functional rather than structural (sclerotic) changes in the cardiovascular system.
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Arzneimittel Forsch · Jan 1985
Comparative Study[General pharmacologic studies on the analgesic flupirtine].
In the present study the general pharmacological properties of ethyl-N-[2-amino-6-(4-fluor-phenylmethylamino)pyridin-3-yl]carbama te (flupirtine, D 9998), a structural new analgesic, are described. In several tests with mice flupirtine shows a centrally depressant component of action. However, regarding undesirable side effects as ataxia, inhibition of motor activity etc. this action is, with respect to the analgesic effective doses less pronounced than those of comparable analgesics, for instance phenacetin. ⋯ Like several other analgesics flupirtine shows in rats a reversible antidiuretic action including sodium and chloride retention which is of relatively short duration and is not observed in long-term studies in rats and dogs. In contrast to many stronger antiinflammatory compounds, flupirtine does not possess ulcerogenic activity in rats up to high doses. A minimal inhibition of intestinal motility (mouse) is observed only in doses higher than the analgesic effective doses.
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Arzneimittel Forsch · Jan 1985
Randomized Controlled Trial Comparative Study Clinical TrialClinical experience and results of treatment with suprofen in pediatrics. 2nd communication: Use of suprofen suppositories as an antipyretic in children with fever due to acute infections/A single-blind controlled study of suprofen versus paracetamol.
The present randomized single-blind trial was performed to study antipyretic effect and tolerability of alpha-methyl-4-(2-thienylcarbonyl)-phenyl acetic acid (suprofen, Suprol) suppositories versus paracetamol (acetaminophen) suppositories in pediatric patients with fever of various etiology. The study included a population of 120 patients ranging in age from 2 to 12 years; the subjects' mean rectal temperature was 39.3 degrees C in the beginning of the therapy. The dosage of the suppositories depended upon body weight; medication was applied up to 3 times a day. ⋯ After the treatment pulse and respiratory rate dropped in both age groups on either treatment. The means were within the normal range at all rating times. The only adverse reaction was vomiting; this phenomenon occurred in 4 cases, i.e., in 2 cases each on either drug.