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
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:
  • 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.


Enrollment: 64
Study Start Date: April 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lubiprostone and placebo Senna
Lubiprostone (Amitiza) 24 µg po BID given with meals for 6 days with two tabs placebo Senna at noon
Drug: Lubiprostone
24 µg po BID given with meals for 6 days
Other Name: Amitiza
Active Comparator: Senna active plus Lubiprostone Placebo
Senna 2 tabs daily for 6 days at noon and placebo Lubiprostone 1 Cap BID
Drug: Senna
2 tabs daily for 6 days
Other Name: Sennasides 8.6 mg each tab

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60302
Sponsors and Collaborators
Rehabilitation Institute of Chicago
Takeda Pharmaceuticals North America, Inc.
Investigators
Principal Investigator: Christina M Marciniak, MD Rehabilitation Institute of Chicago
  More Information

No publications provided

Responsible Party: Christina Marciniak, Attending Physician, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT00662363     History of Changes
Other Study ID Numbers: STU00001168
Study First Received: April 16, 2008
Results First Received: October 23, 2012
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014