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Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis

NCT00771758 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2014-05-09

Study results available
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Summary

The purpose of this study is to determine the effectiveness and safety of tapentadol immediate release (IR) as compared with placebo and oxycodone IR in patients with acute pain caused by vertebral compression fractures (VCF) associated with assumed osteoporosis for whom treatment with oral opioid analgesics is appropriate.

Conditions

Interventions

DRUG

oxycodone IR

maximum daily dose 450 mg

DRUG

placebo

5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days

DRUG

tapentadol IR

50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days

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
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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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 NCT00771758 on ClinicalTrials.gov