Chronic Idiopathic Constipation
Conditions
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.
Interventions
DRUGelobixibat
DRUGplacebo
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| Colonic sensation threshold for pain | At Day 7 |
| Fasting colonic tone | At Day 7 |
| Total 48h fecal bile acid excretion | At Day 4-6 |
| Colonic sensation threshold for first sensation | At Day 7 |
| Colonic sensation threshold for gas | At Day 7 |
Countries
United States
Outcome results
None listed