Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications

This study has been completed.
Sponsor:
Collaborators:
Takeda
Sucampo Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Jack DiPalma, University of South Alabama
ClinicalTrials.gov Identifier:
NCT01096290
First received: March 22, 2010
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

Constipation from medications is a serious and common condition. Lubiprostone has properties that make it a candidate drug. One hundred volunteers with constipation who are taking medications known to cause constipation will be randomized to take lubiprostone or placebo for 28 days. Therapeutic outcome will be evaluated by investigator and study subject assessment.


Condition Intervention Phase
Constipation
Drug: lubiprostone
Drug: Matched placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications

Resource links provided by NLM:


Further study details as provided by University of South Alabama:

Primary Outcome Measures:
  • Relief of constipation defined by modified ROME criteria [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Subjects will report symptoms by questionnaire


Secondary Outcome Measures:
  • Frequency [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Subjects will report stool frequency by questionnaire


Enrollment: 23
Study Start Date: April 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lubiprostone 24mcg BID for 30 days
Active medication
Drug: lubiprostone
24mcg BID, capsule, oral 30days
Other Name: Amitiza
Placebo Comparator: Placebo
Placebo, matched, blinded
Drug: Matched placebo
Twice daily for 30days, oral
Other Name: Placebo, sugar pill

Detailed Description:

Lubiprostone is a novel chloride channel activator that increases intestinal fluid secretion and motility. It is FDA approved and indicated for treatment of chronic idiopathic constipation and recently, constipation-predominant irritable bowel syndrome.

The Physicians Desk Reference lists over 90 Brand medications with reported incidence associated with constipation over 3%. Little data are available about treatment responses. A recent publication by our group reported treatment success for medication constipation using polyethylene glycol. Since ongoing studies are addressing the role of lubiprostone in opioid constipation, this work will be enrolling medication constipation study subjects not using opioids.

In this study, patients who meet diagnostic criteria for constipation will be randomized to receive 28 days of treatment with lubiprostone 24mcg twice a day. Data will be collected to evaluate therapeutic outcome.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult male or female outpatient age 19 or older.
  • Patients meet International Congress of Gastroenterology (ROME III) clinical criteria for constipation*:

    1. Must include two or more of the following:

      1. Straining in > 1/4 defecations;
      2. Lumpy or hard stools > 1/4 defecations;
      3. Sensation of incomplete evacuation in 1/4 defecations;
      4. Sensation of anorectal obstruction/blockage in > 1/4 defecations;
      5. <3 defecations/week.
    2. Loose stools are rarely present without the use of laxatives.
    3. There are insufficient criteria for irritable bowel syndrome. *Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
  • Use of one or more of listed medications known to cause constipation.
  • If female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so during the duration of study. Mandatory compliance is required. Serum pregnancy tests will be performed at screening and during needed follow-up. Negative results will be received before inclusion and administration of first study dose. If pregnancy occurs during the trial, the investigator is notified immediately resulting in prompt discontinuation.
  • Study subjects must not have received lubiprostone for more than 72 hours.
  • Written informed consent.

Exclusion Criteria:

  • Known or suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.
  • Severe diarrhea.
  • Prior small bowel or colonic resection or colostomy.
  • Weight < 80 lbs.
  • If the patient has constipation that according to the investigator's clinical judgment is not the result of constipating medications but is suffering from a secondary cause including but limited to factors that are dietary, neurologic, congenital, diabetic or hypothyroid.
  • Positive stool hemoccult (Can be included if colonoscopic evaluation is subsequently negative).
  • Significant cardiac, renal or hepatic insufficiency.
  • Pregnant or expecting to become pregnant within 120 days of study enrollment.
  • Lactating or breast feeding.
  • Subjects using opioid medications.
  • Subjects who in the opinion of the investigator would be unable to comply adequately with the study plan.
  • Use of investigational drugs in the last 30 days.
  • Patients with known allergy to lubiprostone.
  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: NCT01096290

Locations
United States, Alabama
USA Pavilion at Infirmary West
Mobile, Alabama, United States, 36693
Sponsors and Collaborators
University of South Alabama
Takeda
Sucampo Pharmaceuticals, Inc.
Investigators
Principal Investigator: Jack A DiPalma, M.D. University of South Alabama College of Medicine
  More Information

No publications provided

Responsible Party: Jack DiPalma, Professor of Medicine, University of South Alabama
ClinicalTrials.gov Identifier: NCT01096290     History of Changes
Other Study ID Numbers: 09-250
Study First Received: March 22, 2010
Last Updated: June 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of South Alabama:
constipation
lubiprostone
healthy volunteers

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014