Elobixibat Colonic Motor Function Study

A Single Center, Placebo-controlled Trial to Evaluate the Effects of Elobixibat in Colonic Motor Functions in Patients With Chronic Idiopathic Constipation

This is a randomized trial of 36 otherwise healthy patients with chronic idiopathic constipation. The purpose of the study is to compare the effects of daily single-dose oral elobixibat and placebo for 7 days on colonic motor effects.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Idiopathic Constipation
• Intervention / Treatment: Drug: placebo; Drug: elobixibat

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female 18-65 years of age
• Body Mass Index of 18-40 kg/m2
• Diagnosis of constipation for 12 or more weeks with symptom onset at least 6 months prior to the diagnosis and insufficient criteria to fulfill a diagnosis of irritable bowel syndrome (IBS), as defined by the Rome III criteria for Functional Constipation
• Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to the trial period

Exclusion Criteria:

• Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal (GI) disorders.
• 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, selective serotonin reuptake inhibitor and newer antidepressants
• Use of drugs or agents within the past 2 weeks that may add drowsiness and central nervous system (CNS) depression such as barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, antihistamines, muscle relaxants, and other CNS depressants
• The patient has a history of bariatric surgery for treatment of obesity; surgery to remove a segment of the GI tract; or surgery of the abdomen, pelvic or retroperitoneal area during the 6 months prior to Screening; or appendectomy or cholecystectomy 3 months prior to screening; or other major surgery 1 month prior to Screening
• Clinical evidence (including physical exam) of clinically significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the trial. 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 patients with significant affective disorders

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; placebo	Drug: placebo
Experimental: Elobixibat 10 mg; elobixibat	Drug: elobixibat
Experimental: Elobixibat 15 mg; elobixibat	Drug: elobixibat
Experimental: Elobixibat 20 mg; elobixibat	Drug: elobixibat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of postprandial High Amplitude Propagated Contractions (HAPCs)	At Day 7
Postprandial Colonic Tone	At Day 7
Change in postprandial tone relative to fasting	At Day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Fasting colonic tone	At Day 7
Colonic sensation threshold for first sensation	At Day 7
Colonic sensation threshold for gas	At Day 7
Colonic sensation threshold for pain	At Day 7
Total 48h fecal bile acid excretion	At Day 4-6

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: March 13, 2015
• First Submitted That Met QC Criteria: March 13, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Estimate): June 3, 2015
• Last Update Submitted That Met QC Criteria: June 2, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 000185