At a glance
ClinicalIndex Comparison RecordN/ACompleted· 64 enrolled
Drug / intervention
Lubiprostone +1 moredrug
Likely dose
Lubiprostone 24 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Lubiprostone (Amitiza®) Compared to Standard Care in the Treatment of Postoperative Opioid-induced Constipation in Inpatient Rehabilitation Patients Following Orthopedic Procedures
In Brief
A clinical study evaluating Lubiprostone and Senna for Constipation. Completed, enrolled 64 participants across 1 site.
Detailed Summary
Patients requiring opioids for post-operative pain control following elective orthopedic procedures which has resulted in constipation symptoms, and who are in inpatient rehabilitation will be randomized to two different treatment arms: lubiprostone or senna. Baseline scores regarding constipation and a quality of life bowel questionnaire will be compared the day following 6 days of treatment intervention.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation
CountriesUnited States
CollaboratorsTakeda Pharmaceuticals North America, Inc.
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
First PostedApr 2008
Primary CompletionOct 2011
TodayJul 2026
First PostedApr 21, 2008
Enrollment StartApr 1, 2008
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 18.2 years ago
Interventions
Lubiprostonedrug
24 µg po BID given with meals for 6 days
Sennadrug
2 tabs daily for 6 days