Effect of Ileal Bile Acid Transporter Inhibitor in Functional Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Intervention: A3309; placebo
Intervention description: A3390, a bile acid transport inhibitor was provided in either 15 mg or 20 mg oral tablets; placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: functional constipation; bile acid

Summary:

      This is a single-center, randomized, parallel group, double-blind, placebo-controlled, dose
      response, pharmacodynamic and pharmacokinetic study evaluating the effects of A3309 on
      gastric, intestinal and colonic transit in patients with functional constipation.
    

Eligibility criteria:

        INCLUSION CRITERIA

          1. Females aged 18 to 65 years old inclusive

          2. A diagnosis of functional constipation as defined by two or more of the following:

               1. fewer than three spontaneous complete bowel movements per week

               2. hard or lumpy stools more than 25 % of the time

               3. straining during a bowel movement more than 25 % of the time

          3. A normal rectal exam result on file within the past 2 years or performed at screen to
             exclude the possibility of an evacuation disorder. Examination must exclude findings
             suggestive of an evacuation disorder such as high sphincter tone at rest, failure of
             perineal descent and spasm, tenderness or paradoxical contraction of the puborectalis
             muscles.

          4. Females of child-bearing potential (those who have not experienced a bilateral tubal
             ligation, hysterectomy or menopause) must use an acceptable method of contraception
             during the study. Acceptable methods are surgical sterilization, hormonal methods such
             as oral contraceptives, Norplant and Depo-Provera, double barrier method such as a
             condom and spermicide, and an IUD.

             Abstinent females may participate if they agree to use the double barrier method
             should they become sexually active during the study.

          5. Able to provide written informed consent prior to any study procedures being performed

        EXCLUSION CRITERIA

          1. Female patients who are pregnant or breast feeding

          2. Structural or metabolic diseases/conditions that affect the gastrointestinal system or
             functional gastrointestinal disorders other than constipation. The long version BDQ
             will be used to confirm patients have constipation.

          3. Unable to withdraw all medications 48 hours prior to Visit 1; any medication that
             alters GI transit including but not limited to laxatives, magnesium or
             aluminum-containing antacids. prokinetics, erythromycin, narcotics, anticholinergics,
             tricyclic antidepressants and SNRIs; analgesic drugs including opiates, NSAIDs, and
             COX-2 inhibitors (Note: Tylenol is permitted), GABAergic agents and benzodiazepines.

             Note: All other concomitant medications will be reviewed on a case by case basis by
             the study physicians.

          4. Clinical evidence (including but not limited to a clinically significant abnormal
             physical exam, ECG or laboratory test result in the past medical record) or current
             clinically significant abnormal physical exam or laboratory test result that could
             indicate significant cardiovascular, respiratory, renal, hepatic, gastrointestinal,
             hematological, neurological, psychiatric or other diseases that interfere with the
             objectives of the study. If a laboratory test result is abnormal and clinically
             significant, it may be repeated once at the discretion of the PI. If the laboratory
             test result remains abnormal and clinically significant, the patient will be
             discontinued from the study and referred to a primary care physician for further
             evaluation.

          5. Patients who are considered by the PI to be alcoholics not in remission or known
             substance abusers.

          6. Patients who have participated in another clinical study in the past 30 days.