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Effect of Ileal Bile Acid Transporter Inhibitor in Functional Constipation

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ClinicalTrials.gov Identifier: NCT01038687
Recruitment Status : Completed
First Posted : December 24, 2009
Last Update Posted : August 7, 2012
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Functional Constipation Drug: A3309 Drug: placebo Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of A3309, an Ileal Bile Acid Transport Inhibitor, on Gastrointestinal and Colonic Motor Functions in Female Patients With Functional Constipation
Study Start Date : January 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: A3309 15 mg
Patients randomized to this arm received one oral tablet daily of 15 mg A3309 for a period of 14 consecutive days.
Drug: A3309
A3390, a bile acid transport inhibitor was provided in either 15 mg or 20 mg oral tablets
Other Name: Elobixibat

Experimental: A3309 20 mg
Patients randomized to this arm received one oral tablet daily of 20 mg A3309 for a period of 14 consecutive days.
Drug: A3309
A3390, a bile acid transport inhibitor was provided in either 15 mg or 20 mg oral tablets
Other Name: Elobixibat

Placebo Comparator: Placebo
Patients randomized to this arm received one oral tablet daily of a matching placebo for a period of 14 consecutive days.
Drug: placebo
placebo




Primary Outcome Measures :
  1. Colonic geometric center at 24 h as measured by scintigraphy. [ Time Frame: 24 h ]

Secondary Outcome Measures :
  1. Colonic filling at 6 h measured by scintigraphy. [ Time Frame: 6 h ]
  2. Small bowel transit time, T10% measured by scintigraphy [ Time Frame: day 1 ]
  3. T1/2 of ascending colon emptying measured by scintigraphy. [ Time Frame: first 48 h ]
  4. Colonic geometric center at 48 h measured by scintigraphy. [ Time Frame: 48h ]
  5. Gastric emptying , T1/2 measured by scintigraphy [ Time Frame: day 1 ]
  6. Stool frequency and consistency based on the Bowel Pattern Diary. [ Time Frame: 42 days ]
  7. Pharmacokinetic (PK) characteristics for each dose of A3309. [ Time Frame: 8h ]
  8. Safety and tolerability of A3309 administered as an oral tablet. [ Time Frame: 42 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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): NCT01038687


Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Michael Camilleri, MD Mayo Clinic

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Camilleri, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01038687     History of Changes
Other Study ID Numbers: 09-006618
UL1RR024150 ( U.S. NIH Grant/Contract )
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: August 7, 2012
Last Verified: July 2012

Keywords provided by Mayo Clinic:
functional constipation
bile acid

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Bile Acids and Salts
Gastrointestinal Agents