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A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain

NCT00449176 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 981

Last updated 2012-04-30

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 administrated tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain of the lower back, in comparison with placebo and Oxycodone Controlled Release (CR).

Conditions

  • Low Back Pain

Interventions

DRUG

tapentadol (CG5503) ER

50, 100, 150, 200, 250 mg twice daily for 15 weeks

DRUG

oxycodone CR

10, 20, 30, 40, 50 mg twice daily for 15 weeks

DRUG

placebo

matching placebo twice daily for 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
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-05-31
Completion
2008-05-31

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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 NCT00449176 on ClinicalTrials.gov