A controlled drug trial for 12 weeks plus another 4 weeks to test if Elobixibat 5 and 10 mg helps and is safe for patients with chronic constipatio

Phase 1

• Conditions: Chronic idiopathic constipation; MedDRA version: 17.0Level: LLTClassification code 10072118Term: Chronic idiopathic constipationSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-005588-28-CZ
• Lead Sponsor: Ferring International Pharmascience Center US, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-10
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

1.The patient reports having understood and has signed the Informed Consent Form (ICF) and is willing to comply with all trial visits and assessments
2.The patient is a male or female =18 years of age
3.The patient has a body mass index (BMI) =18.5 but <35.0
4.The patient is ambulatory and community dwelling
5.The patient meets modified Rome III criteria: reports <3 spontaneous BM (SBM; defined as a BM occurring in the absence of any laxative intake in the form of a tablet, a suppository or an enema during the preceding 24 hours) per week and reports one or more of the following symptoms for the last 3 months with symptom onset at least 6 months before the Screening Visit or before starting chronic therapy with any laxative e.g. tegaserod, lubiprostone, linaclotide, polyethylene glycol 3350, prucalopride:
a.Straining during at least 25% of defecations
b.Lumpy or hard stools during at least 25% of defecations
c.Sensation of incomplete evacuation during at least 25% of defecations
6.The patient reports an average of <3 complete SBMs (CSBMs; defined as an SBM associated with a sense of complete evacuation) and =6 SBMs per week by the PDA during the most recent 14 full days before the randomisation visit
7.An initial colonoscopy is required if this is recommended according to national guidelines. If no national guidelines are available, a colonoscopy is performed if recommended according to modified American College of Gastroenterology Guidelines for Colorectal Cancer Screening
8.The patient is compliant with PDA by having adequately responded to the PDA questions on =10 of the most recent 14 full days before the randomisation visit, recording BMs, stool consistency, and gastrointestinal (GI) symptoms (pain, straining, and discomfort)
9.The patient agrees to refrain from making any new, major life-style changes that may affect CIC symptoms (i.e., starting a new diet, changing an exercise plan) from the time of signing the ICF through to the last trial visit.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240

Exclusion Criteria

1.The patient reports loose (mushy) or watery stools (Bristol Stool Form Scale [BSFS] score of 6 or 7) in the absence of any laxative intake in the form of a tablet, a suppository or an enema, or prohibited medicine for >25% of BMs during the 12 weeks prior to the Screening Visit
2.The patient reports a BSFS of 6 or 7 on any day during the Pretreatment Period, unless this occurred within 24 hours of having taken rescue medication.
3.The patient has irritable bowel syndrome (IBS) with pain/discomfort as predominant symptoms as defined by the Rome III criteria: reports abdominal discomfort or pain that has two or more of the following three features the last 3 months with symptom onset at least 6 months before the Screening Visit:
a.Improvement with defecation
b.Onset associated with a change in frequency of stool
c.Onset associated with a change in form (appearance) of stool
4.The patient has a structural abnormality of the GI tract or a disease or condition that can affect GI motility.
5. The patient has a history of any gastro-intestinal disease not considered to be CIC.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified