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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT03335969
Eligibility Criteria:
Inclusion Criteria:
1. Patient has chronic constipation according to Rome III criteria
2. Patient has not experienced relief of symptoms following treatment with available therapies (osmotic and stimulant laxatives) for at least one month at recommended doses.
Exclusion Criteria:
1. Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation)
2. Patient has secondary constipation (colonic obstruction, medications, metabolic cause)
3. Patient has any other condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study.
4. Patient has any of the contraindications listed below:
1. Cardiac: Congestive heart failure (NYHA class III or IV or EF \<50%)
2. GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal surgery
3. GU: Renal insufficiency (CC \< 60 ml/min/173m2), cirrhosis with ascites
4. Abdominal surgery within the last 6 months
5. Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03335969
Study Brief:
Protocol Section:
NCT03335969