NCT00662363

Lubiprostone (Amitiza®) Vs. Standard Care in Opioid-induced Constipation After Surgery in Inpatient Rehabilitation

Lubiprostone (Amitiza®) Compared to Standard Care in the Treatment of Postoperative Opioid-induced Constipation in Inpatient Rehabilitation Patients Following Orthopedic Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to assess the efficacy of Lubiprostone (Amitiza) compared to standard care for the treatment of constipation in orthopedic patients receiving opioids for pain control during inpatient rehabilitation. Lubiprostone (Amitiza®) is a locally acting chloride channel activator that increases intestinal fluid, and thus increases intestinal motility. It has been approved for chronic constipation, but not in the setting of opioid-induced constipation. Senna is a stimulant laxative that increases propulsive peristaltic activity of the colon through local effects on the mucosa. Subjects will be compared using from the Patient Assessment of Constipation (PAC) which has previously been found to be a valid and reliable way to measure constipation symptoms and clinical course. (Frank, Kleinman et al. 1999) as well as with other measures of bowel-related symptoms and functional outcomes.

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	Lubiprostone	24 µg po BID given with meals for 6 days
DRUG	Senna	2 tabs daily for 6 days

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2008-04-21
• Last updated: 2013-03-06
• Results posted: 2013-02-21

Locations

1 site across 1 country: United States