A Randomized, Double-Blind, Parallel-Arm, Placebo and Active Controlled Dose-Ranging Study of the Efficacy and Safety of Multiple Doses of Tapentadol IR for Postoperative Pain Following Bunionectomy Surgery

Pain Clinical Trial

Official title:
A Randomized, Double-Blind, Parallel-Arm, Placebo and Active Controlled Dose-Ranging Study of the Efficacy and Safety of Multiple Doses of CG5503 (Tapentadol) IR for Postoperative Pain Following Bunionectomy Surgery

Status Completed

Clinical Trial Summary

This study was to evaluate the efficacy and safety of dosing regimens of tapentadol HCl immediate release capsules for the treatment of postoperative pain over a period of 12 hours on the first day following a bunionectomy in men and women.

Clinical Trial Description

Tapentadol hydrochloride is a centrally active analgesic (antinociceptive) compound. This was a multicenter, randomized, double-blind, parallel-group, placebo- and active-controlled dose study in men and nonpregnant, nonlactating women. The patients were at least 18 and no more than 75 years of age and experienced moderate to severe pain within 9 hours after removal of postoperative analgesia. The surgery was a standardized first metatarsal bunionectomy. Treatment of postsurgical pain after the 9 hr period was with either placebo, tapentadol, or oxycodone using various dosing regimens. The primary objective of this study was to evaluate the efficacy and safety of these treatments on total pain relief and total change in pain intensity over 12 hours and reporting of adverse events, laboratory values, vital signs, and ECGs. Secondary objectives included evaluation of several other pain measures, and drug pharmacokinetics and pharmacodynamics. Six patient treatment groups received study medication orally at 0, 4, and 8 hours with one of the following dosing regimens: 1) placebo, placebo, and placebo, 2) 93 mg, 93 mg, and 93 mg tapentadol IR, 3) 140 mg, 140 mg, and 140 mg tapentadol IR, 4) 140 mg, 70 mg, and 70 mg tapentadol IR, 5) 186 mg, 93 mg, and 93 mg tapentadol IR, and 6) 10 mg, 10 mg, and 10 mg oxycodone IR. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00806247
Study type	Interventional
Source	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact
Status	Completed
Phase	Phase 2
Start date	January 2005
Completion date	August 2005

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.