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NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain

NCT00986180 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 667

Last updated 2012-12-19

Study results available
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Summary

Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the treatment of acute low back pain.

Conditions

Interventions

DRUG

NUCYNTA

50, 75, or 100 mg every 4 to 6 hours for up to 10 days as needed for pain

DRUG

Oxycodone IR

5, 10, or 15 mg every 4 to 6 hours for up to 10 days as needed for pain

Sponsors & Collaborators

  • Grünenthal GmbH

    collaborator INDUSTRY

  • Ortho-McNeil Janssen Scientific Affairs, LLC

    lead INDUSTRY

Principal Investigators

  • Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial · Ortho-McNeil Janssen Scientific Affairs, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00986180 on ClinicalTrials.gov