NCT02392546

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

1 year

First QC Date

March 13, 2015

Last Update Submit

June 2, 2015

Conditions

Chronic Idiopathic Constipation

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • 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

Study Arms (4)

Elobixibat 10 mg

EXPERIMENTAL

elobixibat

Drug: elobixibat

Elobixibat 15 mg

EXPERIMENTAL

elobixibat

Drug: elobixibat

Elobixibat 20 mg

EXPERIMENTAL

elobixibat

Drug: elobixibat

Placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

elobixibatDRUG
Elobixibat 10 mgElobixibat 15 mgElobixibat 20 mg
placeboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, United States

Location

MeSH Terms

Interventions

elobixibat

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2015

First Posted

March 19, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations

US(1)