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

NCT00806247 | Completed Phase 2

• 1 other identifier: CR004189
• Study Type: interventional
• Target: 480
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain; Postoperative Pain

Keywords

Tapentadol; Bunionectomy; Analgesia; Acute pain; Postsurgical pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Interventions

tapentadol HCl DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Grünenthal GmbH: collaborator

Related Links

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

MeSH Terms

Conditions

Pain; Pain, Postoperative; Agnosia; Acute Pain

Interventions

Tapentadol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 10, 2008
• Study Start: January 1, 2005
• Study Completion: August 1, 2005
• Last Updated: May 18, 2011

Record last verified: 2010-04