A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo Followed by a Voluntary Open Label Extension for Safety.

NCT00364247 | Completed Phase 3

• 1 other identifier: CR011215
• Study Type: interventional
• Target: 602
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 3 different dose levels of CG5503 compared with oxycodone and with placebo in patients who have had a bunionectomy, and to assess the safety of the drug for 9 days after patients are discharged from the hospital.

Conditions

Arthralgia; Bunion; Hallux Valgus; Pain Assessment; Tapentadol

Keywords

Acute pain; bunionectomy

Outcome Measures

Primary Outcomes (1)

• The primary effectiveness outcome for this study is SPID48 (i.e., the sum of pain intensity difference at 48 hours relative to the first dose).

Secondary Outcomes (1)

• Secondary effectiveness outcomes include, among others, the effect of CG5503 IR on the time to the need for the first rescue pain medication during the double-blind treatment period, and the SPID at 12, 24, and 72 hours relative to first dose.

Interventions

CG5503 IR;tapentadol DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must undergo primary unilateral first metatarsal bunionectomy
• pain intensity must be moderate to severe following stoppage of a continuous popliteal sciatic block (a nerve block with local anesthetic that numbs the foot)
• female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active.

You may not qualify if:

• Patients will be excluded from the study if they have a history of seizure disorder or epilepsy
• history of malignancy within the past 2 years before starting the study
• history of alcohol or drug abuse
• evidence of active infections that may spread to other areas of the body
• clinical laboratory values reflecting moderate or severe renal insufficiency
• currently treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake inhibitor (SNRI).

Sponsors & Collaborators

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

Related Publications (1)

• Daniels SE, Upmalis D, Okamoto A, Lange C, Haeussler J. A randomized, double-blind, phase III study comparing multiple doses of tapentadol IR, oxycodone IR, and placebo for postoperative (bunionectomy) pain. Curr Med Res Opin. 2009 Mar;25(3):765-76. doi: 10.1185/03007990902728183.

  PMID: 19203298 DERIVED

Related Links

• A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo Followed by a Voluntary Open Label Extension for Safety.

MeSH Terms

Conditions

Arthralgia; Bunion; Hallux Valgus; Acute Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Foot Deformities, Acquired; Foot Deformities

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 11, 2006
• First Posted: August 15, 2006
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: June 9, 2011

Record last verified: 2011-06