Elobixibat Colonic Motor Function Study

Chronic Idiopathic Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02392546
• Other study ID #: 000185
• Status: Withdrawn
• Phase: Phase 2
• First received: March 13, 2015
• Last updated: June 2, 2015
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: June 2015
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Idiopathic Constipation
• Constipation

Intervention

Drug:
• elobixibat

• placebo

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of postprandial High Amplitude Propagated Contractions (HAPCs)		At Day 7	No
Primary	Postprandial Colonic Tone		At Day 7	No
Primary	Change in postprandial tone relative to fasting		At Day 7	No
Secondary	Fasting colonic tone		At Day 7	No
Secondary	Colonic sensation threshold for first sensation		At Day 7	No
Secondary	Colonic sensation threshold for gas		At Day 7	No
Secondary	Colonic sensation threshold for pain		At Day 7	No
Secondary	Total 48h fecal bile acid excretion		At Day 4-6	No