We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01096290
Recruitment Status : Terminated (Number of needed participants could not be obtained)
First Posted : March 31, 2010
Results First Posted : September 9, 2020
Last Update Posted : November 20, 2020
Sucampo Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of South Alabama

Brief Summary:
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 or disease Intervention/treatment Phase
Constipation Drug: lubiprostone Drug: Matched placebo Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications
Study Start Date : April 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Relief of Constipation Defined by Modified ROME Criteria [ Time Frame: 30 days ]
    Subjects will report symptoms by questionnaire

Secondary Outcome Measures :
  1. Frequency [ Time Frame: 30 days ]
    Subjects will report stool frequency by questionnaire

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096290

Layout table for location information
United States, Alabama
USA Pavilion at Infirmary West
Mobile, Alabama, United States, 36693
Sponsors and Collaborators
University of South Alabama
Sucampo Pharmaceuticals, Inc.
Layout table for investigator information
Principal Investigator: Jack A DiPalma, M.D. University of South Alabama College of Medicine
Layout table for additonal information
Responsible Party: University of South Alabama
ClinicalTrials.gov Identifier: NCT01096290    
Other Study ID Numbers: 09-250
First Posted: March 31, 2010    Key Record Dates
Results First Posted: September 9, 2020
Last Update Posted: November 20, 2020
Last Verified: November 2020
Keywords provided by University of South Alabama:
healthy volunteers
Additional relevant MeSH terms:
Layout table for MeSH terms
Signs and Symptoms, Digestive
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action