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A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety

NCT00364533 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 367

Last updated 2014-04-21

Study results available
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Summary

The purpose of this study is to test in patients who have had hip replacement surgery the effectiveness (level of pain control) and the safety of 3 different dose levels of CG5503 compared with placebo and with 10-mg oxycodone during the 72-hour double-blind period and to assess the safety of the drug for 9 days after patients completed the double blind period.

Conditions

  • Arthroplasty

Interventions

DRUG

Tapentadol IR (CG5503)

Fixed Dose 50, 75, \& 100 mg BID for 3 days

DRUG

Placebo

Fixed Dose Matching placebo for 3 days

DRUG

Oxycodone HCL IR

Fixed Dose 10 mg BID for 3 days

DRUG

Tapentadol IR (CG5503)

Flexible Dose q4-6 hr Tapentadol IR 50 \& 100 mg BID for 9 days

Sponsors & Collaborators

  • Grünenthal GmbH

    collaborator INDUSTRY

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

    lead INDUSTRY

Principal Investigators

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

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
2006-10-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States
  • Belgium
  • Canada
  • Finland
  • New Zealand
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT00364533 on ClinicalTrials.gov