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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02392546
Other study ID # 000185
Secondary ID
Status Withdrawn
Phase Phase 2
First received March 13, 2015
Last updated June 2, 2015
Start date April 2015
Est. completion date April 2016

Study information

Verified date June 2015
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
elobixibat

placebo


Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of postprandial High Amplitude Propagated Contractions (HAPCs) At Day 7 No
Primary Postprandial Colonic Tone At Day 7 No
Primary Change in postprandial tone relative to fasting At Day 7 No
Secondary Fasting colonic tone At Day 7 No
Secondary Colonic sensation threshold for first sensation At Day 7 No
Secondary Colonic sensation threshold for gas At Day 7 No
Secondary Colonic sensation threshold for pain At Day 7 No
Secondary Total 48h fecal bile acid excretion At Day 4-6 No
See also
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Completed NCT02819297 - BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults Phase 3