Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT01692132
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of chronic constipation by history and physical examination, including rectal exam
* History of chronic constipation not satisfied with laxatives
* Patient reports, on average, 2 or fewer spontaneous bowel movements (SBMs) per week and 1 or more of the following for the last three months: very hard (little balls) and/or hard stools in more than 25% of bowel movements (BMs); sensation of incomplete evacuation in more than 25% of BMs; straining at defecation in more than 25% of BMs; sensation of ano-rectal obstruction or blockade in more than 25% of BMs; a need for digital manipulation to facilitate evacuation in more than 25% of BMs
* Females of childbearing potential agree to use highly effective contraceptive methods
Exclusion Criteria:
* Renal impairment requiring dialysis
* Secondary chronic constipation and organic gastrointestinal (GI) disorders
* Intestinal perforation / obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory condition of the intestinal tract such as Crohn's disease, ulcerative colitis, toxic megacolon / rectum
* Hypersensitive to Prucalopride or to any of its components
* Patients receiving concomitant drugs known to cause QTc prolongation
* Pregnant or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01692132
Study Brief:
Protocol Section:
NCT01692132