Clinical trial NCT00662363: Lubiprostone (Amitiza®) Vs. Standard Care in Opioid-induced Constipation After Surgery in Inpatient Rehabilitation
Official title: Lubiprostone (Amitiza®) Compared to Standard Care in the Treatment of Postoperative Opioid-induced Constipation in Inpatient Rehabilitation Patients Following Orthopedic Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: constipation
opioid
rehabilitation
post-operative
orthopedic
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Takeda Pharmaceuticals North America, Inc.
First posted: 2008-04-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Change in Patient Assessment of Constipation (PAC) - Symptoms (Sym)
timeFrame: Baseline and Day 7, after treatment completed (6 days of treatment)
measure: Change in Patient Assessment of Constipation - Quality of Life
timeFrame: Baseline and day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Christina M Marciniak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marciniak CM, Toledo S, Lee J, Jesselson M, Bateman J, Grover B, Tierny J. Lubiprostone vs Senna in postoperative orthopedic surgery patients with opioid-induced constipation: a double-blind, active-comparator trial. World J Gastroenterol. 2014 Nov 21;20(43):16323-33. doi: 10.3748/wjg.v20.i43.16323.