Back to resultsElobixibat Colonic Motor Function Study
Primary Purpose
Chronic Idiopathic Constipation
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
elobixibat
placebo
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Idiopathic Constipation
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Elobixibat 10 mg
Elobixibat 15 mg
Elobixibat 20 mg
Placebo
Arm Description
elobixibat
elobixibat
elobixibat
placebo
Outcomes
Primary Outcome Measures
Number of postprandial High Amplitude Propagated Contractions (HAPCs)
Postprandial Colonic Tone
Change in postprandial tone relative to fasting
Secondary Outcome Measures
Fasting colonic tone
Colonic sensation threshold for first sensation
Colonic sensation threshold for gas
Colonic sensation threshold for pain
Total 48h fecal bile acid excretion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02392546
Brief Title
Elobixibat Colonic Motor Function Study
Official Title
A Single Center, Placebo-controlled Trial to Evaluate the Effects of Elobixibat in Colonic Motor Functions in Patients With Chronic Idiopathic Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Business reasons
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Constipation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elobixibat 10 mg
Arm Type
Experimental
Arm Description
elobixibat
Arm Title
Elobixibat 15 mg
Arm Type
Experimental
Arm Description
elobixibat
Arm Title
Elobixibat 20 mg
Arm Type
Experimental
Arm Description
elobixibat
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
elobixibat
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Number of postprandial High Amplitude Propagated Contractions (HAPCs)
Time Frame
At Day 7
Title
Postprandial Colonic Tone
Time Frame
At Day 7
Title
Change in postprandial tone relative to fasting
Time Frame
At Day 7
Secondary Outcome Measure Information:
Title
Fasting colonic tone
Time Frame
At Day 7
Title
Colonic sensation threshold for first sensation
Time Frame
At Day 7
Title
Colonic sensation threshold for gas
Time Frame
At Day 7
Title
Colonic sensation threshold for pain
Time Frame
At Day 7
Title
Total 48h fecal bile acid excretion
Time Frame
At Day 4-6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
Country
United States
12. IPD Sharing Statement
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Elobixibat Colonic Motor Function Study
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