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Tapentadol (CG5503)

NCT00421928 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1030

Last updated 2012-04-18

Study results available
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Summary

The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain due to osteoarthritis of the knee, in comparison with placebo and Oxycodone Controlled Release (CR).

Conditions

  • Osteoarthritis, Knee
  • Pain

Interventions

DRUG

oxycodone

10, 20, 30, 40, 50mg twice a day (BID) during 15 weeks

DRUG

placebo

matching placebo twice a day (BID) during 15 weeks

DRUG

tapentadol (CG5503)

50, 100, 150, 200, 250mg twice a day (BID) during 15 weeks

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
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-07-31
Completion
2008-12-31

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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 NCT00421928 on ClinicalTrials.gov