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A Study to Compare the Frequency of Constipation Symptoms With Tapentadol Immediate Release (IR) Treatment Versus Oxycodone IR Treatment in Patients With End-stage Joint Disease

NCT00784277 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 597

Last updated 2012-02-13

Study results available
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Summary

The purpose of this study is to compare bowel function/constipation that occurs during tapentadol treatment with that occuring during oxycodone treatment, as measured by the frequency of spontaneous bowel movements per week. The frequency of spontaneous bowel movements will be determined from a Bowel Function Patient Diary completed by the enrolled sujbects.

Conditions

Interventions

DRUG

oxycodone CR

flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)

DRUG

oxycodone IR

10mg for 14 days

DRUG

Tapentadol ER (CG5503)

flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)

DRUG

Tapentadol IR (CG5503)

50mg for 14 days

DRUG

Tapentadol IR (CG5503)

75mg for 14 days

DRUG

placebo

1 capsule for 14 days

DRUG

placebo

Tablets and capsules 2 x a day for 28 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
2008-10-31
Primary Completion
2009-07-31
Completion
2009-07-31

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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 NCT00784277 on ClinicalTrials.gov