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Sponsored by: |
Rehabilitation Institute of Chicago |
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Information provided by: | Rehabilitation Institute of Chicago |
ClinicalTrials.gov Identifier: | NCT00662363 |
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.
Condition | Intervention |
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Constipation |
Drug: Lubiprostone Drug: Senna |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Lubiprostone (Amitiza®) Compared to Standard Care in the Treatment of Postoperative Opioid-Induced Constipation in Inpatient Rehabilitation Patients Following Orthopedic Procedures |
Estimated Enrollment: | 70 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Lubiprostone (Amitiza) 24 µg po BID given with meals for 6 days
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Drug: Lubiprostone
24 µg po BID given with meals for 6 days
Drug: Senna
2 tabs daily for 6 days
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B: Active Comparator
Senna 2 tabs daily for 6 days
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Drug: Senna
2 tabs daily for 6 days
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
At least one associated symptom of constipation at the time of admission, such as, but not limited to:
Exclusion Criteria:
Pre-existing medical condition or surgical procedure, which is known to commonly lead to bowel dysfunction such as, but not limited to:
Contact: Christina Marciniak, MD | 312-238-4740 | cmarciniak@ric.org |
Contact: Jillian Bateman, OTR | jdworak@ric.org |
United States, Illinois | |
Rehabilitation Institute of Chicago | Recruiting |
Chicago, Illinois, United States, 60302 | |
Contact: Christina M Marciniak, MD 312-238-4740 cmarciniak@ric.org |
Principal Investigator: | Christina M Marciniak, MD | Rehabilitation Institute of Chicago |
Responsible Party: | Rehabilitation Institute of Chicago ( Christina Marciniak, MD ) |
Study ID Numbers: | STU00001168 |
Study First Received: | April 16, 2008 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00662363 History of Changes |
Health Authority: | United States: Food and Drug Administration |
constipation opioid rehabilitation post-operative orthopedic |
Signs and Symptoms Signs and Symptoms, Digestive Senna Sennoside A&B Constipation |
Central Nervous System Depressants Peripheral Nervous System Agents Analgesics Senna Extract Analgesics, Opioid |
Signs and Symptoms Signs and Symptoms, Digestive Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Constipation |
Central Nervous System Depressants Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |