Elobixibat Colonic Motor Function Study

Phase 2

Withdrawn

• Conditions: Chronic Idiopathic Constipation
• Interventions: Drug: placebo; Drug: elobixibat

• Registration Number: NCT02392546
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-13
• Study First Submitted QC: 2015-03-13
• Study First Posted: 2015-03-19
• Study Start: 2015-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-03
• Primary Completion: 2016-04
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	placebo
Elobixibat 15 mg	elobixibat	elobixibat
Elobixibat 10 mg	elobixibat	elobixibat
Elobixibat 20 mg	elobixibat	elobixibat

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States