At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Arm, Multicenter Study in Subjects With End-Stage Joint Disease to Compare the Frequency of Constipation Symptoms in SubjectsTreated With Tapentadol IR and Oxycodone IR Using a Bowel Function Patient Diary
In Brief
A Phase 3 clinical trial evaluating oxycodone CR, oxycodone IR, and 3 other interventions for Joint Diseases and 2 related conditions. Completed, enrolled 597 participants.
Detailed 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.
Study Details
Timeline
Interventions
flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
10mg for 14 days
flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
50mg for 14 days
75mg for 14 days
1 capsule for 14 days
Tablets and capsules 2 x a day for 28 days