Lubiprostone, Colonic Motility and Sensation
Condition: Healthy
Intervention: lubiprostone; Placebo; Bowel preparation
Intervention description: Lubiprostone 24 micrograms, one dose daily for three days in 30 subjects; Placebo medication given for three days; Polyethylene glycol-based bowel preparation
Intervention MeSH terms: Lubiprostone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: lubiprostone; colon; motility; sensation

Summary:

      This study is being done to evaluate the effects of lubiprostone, a drug approved and used
      for constipation, on pattern of contractions of the colon and the colon's sensitivity to
      distension.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy subjects

          -  Body mass index (BMI): 18 to 32.

          -  Negative pregnancy test for women of childbearing potential.

          -  Absence of gastrointestinal symptoms (abridged Bowel Disease Questionnaire).

          -  Signed informed consent.

        Exclusion criteria:

          -  Subjects with body mass index (BMI) of less than 18 or more than 32.

          -  Structural or metabolic diseases/conditions that affect the gastrointestinal
             (GI)system, or functional gastrointestinal disorders. For screening, the Bowel Disease
             Questionnaire will be used to exclude subjects with irritable bowel syndrome.

          -  Use of drugs or agents within the past 2 weeks that alter GI transit including
             laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin,
             narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer
             antidepressants.

        NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for
        cardioprotection, and birth control pills or depot injections are permissible.

          -  Use of drugs or agents within the 2 weeks prior to screening that may add drowsiness
             and central nervous system (CNS) depression such as barbiturates, benzodiazepines,
             ethanol, lithium, opioids, buspirone, antihistamines, muscle relaxants, other CNS
             depressants.

          -  Female subjects who are pregnant or breast feeding.

          -  Females must be either surgically sterilized, postmenopausal (>12 months since last
             menses) or, if of childbearing potential, using reliable methods of contraception as
             determined by the physician (single-barrier methods alone and rhythm methods are not
             acceptable).

          -  Clinical evidence (including physical exam and ECG) of significant cardiovascular,
             respiratory, renal, hepatic, gastrointestinal, hematological, neurological,
             psychiatric, or other disease that interfere with the objectives of the study. Any
             candidate participants with such disorder mentioned will be referred to their general
             physician.

          -  The Hospital Anxiety and Depression Scale (HADS) will be used to exclude subjects with
             significant affective disorders, as well as to determine anxiety and depression scores
             at the start of the study. Any candidate participants with such disorder mentioned
             will be referred to their general physician.

          -  Symptoms of a significant clinical illness in the two weeks prior to screening.

          -  Participation in another clinical study within the 30 days prior to screening.

          -  Subjects who are considered by the investigator to be alcoholics not in remission or
             known substance abusers.