International journal of clinical pharmacology research
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Int J Clin Pharmacol Res · Jan 2001
Randomized Controlled Trial Multicenter Study Clinical TrialShort-term treatment of primary fibromyalgia with the 5-HT3-receptor antagonist tropisetron. Results of a randomized, double-blind, placebo-controlled multicenter trial in 418 patients.
We investigated the efficacy and tolerability of short-term treatment with tropisetron, a selective, competitive 5-HT3-receptor antagonist in fibromyalgia. The trial was designed as a prospective, multicenter, double-blind, parallel-group, dose-finding study. We randomly assigned 418 patients suffering from primary fibromyalgia to receive either placebo, 5 mg, 10 mg or 15 mg tropisetron once daily for 10 days. ⋯ The safety and tolerability of tropisetron was good; gastrointestinal tract symptoms were the most frequently reported adverse events. Short-term treatment of fibromyalgia patients with 5 mg tropisetron for 10 days proved to be efficacious and well tolerated. In this study a bell-shaped dose-response curve was seen.
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Int J Clin Pharmacol Res · Jan 1999
Randomized Controlled Trial Comparative Study Clinical TrialAnalgesic effects of diclofenac suppository and injection after preoperative administration.
Diclofenac sodium (100 mg) has been introduced in the Caribbean as a suppository formulation. In a randomized single-blind (observer-blind) clinical trial, the postoperative analgesic efficacy of diclofenac administered either as a conventional intramuscular injection (75 mg) or as the available suppository formulation (100 mg) was studied in 44 adult male patients undergoing herniorrhaphy in same day surgery. Diclofenac was administered preoperatively at induction of anesthesia to patients (grades ASA I and II) after they had given informed consent. ⋯ The times for requests for additional analgesia and the number of patients requesting further analgesia did not differ. Patients who received the suppository were discharged earlier than those who received the injection (40 min vs. 65 min p = 0.02). This preliminary study of the two marketed formulations of diclofenac demonstrated that both preparations provided equivalent analgesia but patients who received the suppository preparation were discharged earlier.
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Int J Clin Pharmacol Res · Jan 1998
Randomized Controlled Trial Clinical TrialThe postoperative analgesic efficacy and safety of piroxicam (FDDF) and naproxen sodium.
The aim of the present study was to compare the analgesic efficacy of piroxicam-FDDF (fast dissolving dosage form) with naproxen sodium, following bilateral removal of impacted third molars. A double-blind, randomized, crossover, analgesic trial was carried out on 40 patients undergoing surgical removal of one lower third molar at each visit. The analgesic efficacy of a single dose regimen of piroxicam-FDDF (40 mg, Feldene Flash, Pfizer, Turkey) was compared with naproxen sodium (550 mg, Anaprotab, Sanli, Turkey). ⋯ After 90 min to 8 h, no statistical significance was revealed among the two test groups (p > 0.05). The peak pain relief, maximal analgesic effect, SPID, TOTPAR values, adjusted mean number of observations with pain at least half-relieved, and the final overall evaluation records were all superior for piroxicam-FDDF (p < 0.05). The results of this study clearly show that the analgesic efficacy of piroxicam-FDDF is superior to naproxen sodium in the treatment of pain following oral surgery for the removal of impacted third molars.
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Int J Clin Pharmacol Res · Jan 1998
Randomized Controlled Trial Comparative Study Clinical TrialDiuretic effects of furosemide infusion versus bolus injection in congestive heart failure.
In a randomized, single-blind, crossover clinical trial, the diuretic efficacy of the same total dose of furosemide (2 x 40 mg) administered in either conventional intravenous bolus injection or continuous infusion was studied in 20 patients (nine males and 11 females), aged 37-75 years, with congestive heart failure. Furosemide infusion, administered first, produced a significantly greater diuresis than the bolus when compared with baseline (86%: 29.6%; p = 0.029). This was followed by a similar increase in 24-h urinary sodium, potassium and chloride excretion, with no significant difference from the bolus effect. ⋯ Nevertheless, when continuous furosemide infusion was administered first, it produced a greater increase in urinary volume, 24-h urinary sodium, potassium and chloride than when bolus injection was applied the next day. Conversely, when furosemide bolus was administered first, followed by the infusions the next day, the effects were almost equal, regardless of the mode of administration. It is concluded that in the treatment of refractory edema in patients with congestive heart failure, continuous intravenous infusion of furosemide is superior to the conventional intermittent bolus injection, especially if it is administered at the very beginning of the hospital treatment, and presumably is even better with higher dosage and longer infusion time span.
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Int J Clin Pharmacol Res · Jan 1998
Randomized Controlled Trial Clinical TrialTramadol in the fibromyalgia syndrome: a controlled clinical trial versus placebo.
This study assessed the analgesic action of tramadol compared with placebo in patients suffering from fibromyalgia syndrome. Twelve patients (11 females, one male) were treated according to a double-blind crossover experimental design. Each patient, after signing informed consent, was randomly allocated to either tramadol (100 mg ampul in 100 ml given intravenously in 15 min doses) or placebo for a single dose treatment. ⋯ During the first treatment cycle effective control of spontaneous pain was achieved with tramadol, which determined a reduction of 20.6% while with the placebo spontaneous pain increased by 19.8%. With pressure dolorimetry there were no clinically important differences observed after either active treatment or placebo. The contrasting results found in the present study could be a stimulus for the organization of new projects, which may lead to the identification of an optimal therapeutic approach for fibromyalgic patients, also using tramadol for long periods.