Status:
COMPLETED
Lubiprostone (Amitiza®) Vs. Standard Care in Opioid-induced Constipation After Surgery in Inpatient Rehabilitation
Lead Sponsor:
Shirley Ryan AbilityLab
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
Constipation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 randomi...
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 duri...
Eligibility Criteria
Inclusion
- Adult, 18 years old or greater.
- The patient is able to provide informed consent.
- Anticipated duration of hospitalization of at least 7 days.
- Woman of childbearing potential must have a negative serum pregnancy test at enrollment. Exclusions for testing include two years or greater postmenopausal, hysterectomy or tubal ligation.
- Use of opioid for post-op analgesia following orthopedic surgical procedures as defined as IV, IM, transdermal or PO opioid received within the prior 24 hours of hospitalization for pain control, and expectation that an opioid will be continued for pain control.
- Medication may be administered on a PRN (as needed) basis or scheduled basis
- One or greater doses has been received within the 24 hours prior to enrollment as determined by medication administration recorded from the acute care facility or RIC MAR.
- At least one associated symptom of constipation at the time of admission, such as, but not limited to:
- Lumpy or Hard stools
- Feeling of incomplete evacuation of bowels
- Abdominal cramping or pain
- Straining with movement of bowels or painful bowel movement effort
- Need for manual assistance to have a bowel movement
Exclusion
- Known allergy or sensitivity to the study medications
- Females who are pregnant
- Diarrhea on the day of admission
- Diagnosis of Clostridium difficile infection during the current hospitalization
- Pre-existing medical condition or surgical procedure, which is known to commonly lead to bowel dysfunction such as, but not limited to:
- Crohn's disease
- Ulcerative colitis
- Multiple sclerosis
- Cerebral palsy
- Spinal Cord Injury
- Colectomy
- Malabsorption Syndrome
- Irritable Bowel Syndrome
- Abdominopelvic neoplasm (gastric, colon cancer)
- Severe liver disease
- Colonic or ileo-colonic resections
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00662363
Start Date
April 1 2008
End Date
October 1 2011
Last Update
March 6 2013
Active Locations (1)
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1
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60302