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A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy

NCT00609466 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 291

Last updated 2011-11-16

Study results available
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Summary

The main objective of this trial is to demonstrate the efficacy and safety of multiple-dose application of oral application of CG5503 IR 75mg compared to placebo and to assess safety and tolerability of CG5503 IR 75mg in subjects following bunionectomy.

This trial was performed based on a previously performed double-blind, placebo-controlled, multiple-dose trial in the same indication investigating 3 dose strengths CG5503 IR (50, 75 and 100 mg) published under PMID: 18851776.

Conditions

  • Bunionectomy
  • Pain
  • Postoperative Pain
  • Acute Pain

Interventions

DRUG

CG5503 IR

75mg IR 4 - 6 hourly Total: 72 hours

DRUG

Morphine

Morphine 30 mg IR 4 - 6 hourly Total: 72 hours

DRUG

Placebo

Placebo; 4 - 6 hourly; Total: 72 hours

Sponsors & Collaborators

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

    collaborator INDUSTRY

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Stephen E Daniels, DO · Premier Research Group (formerly SCIREX Corporation)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00609466 on ClinicalTrials.gov