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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT01869751
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 and ≤ 85 years
* Chronic slow-transit constipation as defined be 4 criteria:
1. having two or fewer spontaneous complete bowel movements week for a minimum of 6 months
2. having one or more of the following symptoms for at least one-quarter of the time: lumpy/hard stools, a sensation of incomplete evacuation, or straining during defecation.
3. slow transit time as determined by Rx colon transit study ("pellet")
4. without evidence of secondary constipation or primary defecation disorder
* Need of therapy with prucalopride (i.e., inefficacy of dietary changes and laxatives)
* Follow-up visit possible after 4 weeks of treatment
* Written informed consent
Exclusion Criteria:
* History or new diagnosis of organic intestinal disease (e.g., inflammatory bowel disease, malignancy)
* Secondary constipation (drug-induced, endocrine, metabolic or neurological disorders, surgery, known or suspected organic disorders of the large intestine, or megacolon) or primary defecation disorder
* Use of laxatives two days before start of treatment and during treatment period. If there is no spontaneous bowel movement during 3 consecutive days, rescue treatment with bisacodyl and/or enema is allowed if necessary
* Presence of significant co-morbidity (uncontrolled heart, liver and lung disease)
* Pregnancy
* Chronic kidney disease, i.e., estimated glomerular filtration rate (MDRD) \< 60 ml/min/m² or need of dialysis therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01869751
Study Brief:
Protocol Section:
NCT01869751