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

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.

Study Overview

• Status: Terminated
• Conditions: Constipation
• Intervention / Treatment: Drug: lubiprostone; Drug: Matched placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36693
      • USA Pavilion at Infirmary West

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lubiprostone 24mcg BID for 30 days; Active medication	Drug: lubiprostone; 24mcg BID, capsule, oral 30days; Other Names: Amitiza
Placebo Comparator: Placebo; Placebo, matched, blinded	Drug: Matched placebo; Twice daily for 30days, oral; Other Names: Placebo, sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relief of Constipation Defined by Modified ROME Criteria	Subjects will report symptoms by questionnaire	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency	Subjects will report stool frequency by questionnaire	30 days

Collaborators and Investigators

• Sponsor: University of South Alabama
• Collaborators: Takeda; Sucampo Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Jack A DiPalma, M.D., University of South Alabama College of Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: March 22, 2010
• First Submitted That Met QC Criteria: March 29, 2010
• First Posted (Estimate): March 31, 2010

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: healthy volunteers; constipation; lubiprostone
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Chloride Channel Agonists; Lubiprostone
• Other Study ID Numbers: 09-250