Elobixibat Colonic Motor Function Study
Status: | Completed |
---|---|
Conditions: | Constipation |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 7/11/2015 |
Start Date: | April 2015 |
End Date: | April 2016 |
Contact: | Clinical Development Support |
Email: | DK0-Disclosure@ferring.com |
A Single Center, Placebo-controlled Trial to Evaluate the Effects of Elobixibat in Colonic Motor Functions in Patients With Chronic Idiopathic Constipation
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.
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.
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
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