EUCTR2012-005587-94-CZ
Active, not recruiting
Phase 1
A Double-blind, Randomised, Placebo-controlled, Phase 3 Trial in Patients with Chronic Idiopathic Constipation to Demonstrate the Efficacy and Safety of Elobixibat 5 mg and 10 mg for 26 Weeks - Echo 1
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic idiopathic constipation
- Sponsor
- Ferring International Pharmascience Center US, Inc.
- Enrollment
- 840
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 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
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.
Outcomes
Primary Outcomes
Not specified
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