Lubiprostone (Amitiza®) Vs. Standard Care in Opioid-induced Constipation After Surgery in Inpatient Rehabilitation

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Christina Marciniak, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT00662363
First received: April 16, 2008
Last updated: February 27, 2013
Last verified: February 2013

April 16, 2008
February 27, 2013
April 2008
October 2011   (final data collection date for primary outcome measure)
  • Change in Patient Assessment of Constipation (PAC) - Symptoms (Sym) [ Time Frame: Baseline and Day 7, after treatment completed (6 days of treatment) ] [ Designated as safety issue: No ]
    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).
  • Change in Patient Assessment of Constipation - Quality of Life [ Time Frame: Baseline and day 7 ] [ Designated as safety issue: No ]
    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.
Patient assessment of constipation [ Time Frame: Baseline and following 6 days of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00662363 on ClinicalTrials.gov Archive Site
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Lubiprostone (Amitiza®) Vs. Standard Care in Opioid-induced Constipation After Surgery in Inpatient Rehabilitation
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Constipation
  • Drug: Lubiprostone
    24 µg po BID given with meals for 6 days
    Other Name: Amitiza
  • Drug: Senna
    2 tabs daily for 6 days
    Other Name: Sennasides 8.6 mg each tab
  • Experimental: Lubiprostone and placebo Senna
    Lubiprostone (Amitiza) 24 µg po BID given with meals for 6 days with two tabs placebo Senna at noon
    Intervention: Drug: Lubiprostone
  • Active Comparator: Senna active plus Lubiprostone Placebo
    Senna 2 tabs daily for 6 days at noon and placebo Lubiprostone 1 Cap BID
    Intervention: Drug: Senna
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00662363
STU00001168
No
Christina Marciniak, Rehabilitation Institute of Chicago
Rehabilitation Institute of Chicago
Takeda Pharmaceuticals North America, Inc.
Principal Investigator: Christina M Marciniak, MD Rehabilitation Institute of Chicago
Rehabilitation Institute of Chicago
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP