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Lubiprostone (Amitiza®) Vs. Standard Care in Opioid-Induced Constipation After Surgery in Inpatient Rehabilitation
This study is currently recruiting participants.
Verified by Rehabilitation Institute of Chicago, April 2009
First Received: April 16, 2008   Last Updated: April 15, 2009   History of Changes
Sponsored by: Rehabilitation Institute of Chicago
Information provided by: Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT00662363
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Rehabilitation Institute of Chicago:

Primary Outcome Measures:
  • Patient assessment of constipation [ Time Frame: Baseline and following 6 days of treatment ] [ Designated as safety issue: No ]

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
A: Experimental
Lubiprostone (Amitiza) 24 µg po BID given with meals for 6 days
Drug: Lubiprostone
24 µg po BID given with meals for 6 days
Drug: Senna
2 tabs daily for 6 days
B: Active Comparator
Senna 2 tabs daily for 6 days
Drug: Senna
2 tabs daily for 6 days

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662363

Contacts
Contact: Christina Marciniak, MD 312-238-4740 cmarciniak@ric.org
Contact: Jillian Bateman, OTR jdworak@ric.org

Locations
United States, Illinois
Rehabilitation Institute of Chicago Recruiting
Chicago, Illinois, United States, 60302
Contact: Christina M Marciniak, MD     312-238-4740     cmarciniak@ric.org    
Sponsors and Collaborators
Rehabilitation Institute of Chicago
Investigators
Principal Investigator: Christina M Marciniak, MD Rehabilitation Institute of Chicago
  More Information

No publications provided

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

Keywords provided by Rehabilitation Institute of Chicago:
constipation
opioid
rehabilitation
post-operative
orthopedic

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 10, 2009