Elobixibat Colonic Motor Function Study

Ferring

Status and phase: Withdrawn; Phase 2

Conditions: Chronic Idiopathic Constipation

Treatments: Drug: placebo; Drug: elobixibat

Study type: Interventional

Funder types: Industry

Identifiers

NCT02392546

000185

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups, including a placebo group

Elobixibat 10 mg

Experimental group

Description:

elobixibat

Treatment:

Drug: elobixibat

Elobixibat 15 mg

Experimental group

Description:

elobixibat

Treatment:

Drug: elobixibat

Elobixibat 20 mg

Experimental group

Description:

elobixibat

Treatment:

Drug: elobixibat

Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo