Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications
Condition: Constipation
MeSH terms: Constipation
Intervention: lubiprostone; Matched placebo
Intervention description: 24mcg BID, capsule, oral 30days; Twice daily for 30days, oral
Intervention MeSH terms: Lubiprostone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: constipation; lubiprostone; healthy volunteers

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.
    

Eligibility 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.