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

Phase 2

Completed

• Conditions: Pain; Postoperative Pain

• Registration Number: NCT00806247
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief 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.

Detailed 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 Timeline

• Study Start: 2005-01
• Study Completion: 2005-08
• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2008-12-08
• Study First Posted: 2008-12-10
• Status Verified: 2010-04
• Last Update Submitted: 2011-05-17
• Last Update Posted: 2011-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• Moderate to severe pain intensity within 9 hours of the discontinuation of the popliteal block, and permitted supplemental systemic analgesics, if taken, during the postoperative surgical period
• Moderate to severe categorical pain intensity and a pain intensity VAS = 40 mm

Exclusion Criteria

• Randomization less than 10 hours after initiation of the standardized first metatarsal bunionectomy
• History of seizure (including febrile seizure), or loss of consciousness due to head trauma
• Use of antiparkinsonian drugs, neuroleptics, anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), SSRIs, and SNRIs at any time within 30 days of surgery and throughout the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary objective was that at least 1 of the treatment regimens with tapentadol IR was superior to placebo as measured by the sum of total pain relief and sum of pain intensity difference over 12 hours (SPRID12) on the first day after a bunionectomy.

Secondary Outcome Measures

Name	Time	Method
Secondary objectives included evaluation of several additional pain measures, tolerability to treatments, and drug pharmacokinetics and pharmacodynamics.