Constipation Clinical Trial
Official title:
Lubiprostone (Amitiza®) Compared to Standard Care in the Treatment of Postoperative Opioid-induced Constipation in Inpatient Rehabilitation Patients Following Orthopedic Procedures
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Adult, 18 years old or greater. 2. The patient is able to provide informed consent. 3. Anticipated duration of hospitalization of at least 7 days. 4. 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. 5. 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. 6. 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 Criteria: 1. Known allergy or sensitivity to the study medications 2. Females who are pregnant 3. Diarrhea on the day of admission 4. Diagnosis of Clostridium difficile infection during the current hospitalization 5. 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Rehabilitation Institute of Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Rehabilitation Institute of Chicago | Takeda Pharmaceuticals North America, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Patient Assessment of Constipation (PAC) - Symptoms (Sym) | Patient Assessment of Constipation (PAC) - Change in this measure was assessed. The PAC has previously been found to be a valid and reliable way to measure constipation symptoms and clinical course. The PAC has two components. The symptom (SYM) component is composed of 12 items with score range 0-4 with lower scores indicating improvement. Scores within the two domains were separately averaged. The PAC-SYM questionnaire has shown good concurrent and clinical validity for opioid-induced constipation in a number of pain populations and has demonstrative responsiveness to treatment. There are three symptom domains within the PAC-SYM: Abdominal symptoms (4 items), rectal symptoms (3 items) and stool symptoms (5 items). | Baseline and Day 7, after treatment completed (6 days of treatment) | No |
Primary | Change in Patient Assessment of Constipation - Quality of Life | The second component of the PAC is the quality of life (QOL) component.The quality of life (QOL) component consists of five items that are rated on a 0-4 scale with higher scores indicating better QOL. Scores within the domains are averaged. | Baseline and day 7 | No |
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