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 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
NCT ID:
NCT02726295
Eligibility Criteria:
Inclusion Criteria:
* Adult male or female outpatients aged from 20 to 75 years old.
* Patients meet International Congress of Gastroenterology (ROME III) clinical criteria for constipation\*:
A. Must include two or more of the following:
1. Straining in \> 1/4 defecations;
2. Lumpy or hard stools \> 1/4 defecations;
3. Sensation of incomplete evacuation in 1/4 defecations;
4. Sensation of anorectal obstruction/blockage in \> 1/4 defecations;
5. \<3 defecations/week.
B.Loose stools are rarely present without the use of laxatives. C.There are insufficient criteria for irritable bowel syndrome. \*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
Exclusion Criteria:
* Pregnant or lactating woman
* Known organic gastrointestinal disease
* Subjects who diagnosed advanced adenoma within 3 years
* Prior gastrointestinal surgery (except appendectomy, herniotomy)
* Subjects who diagnosed irritable bowel syndrome
* Use of one or more of listed medications within 2 weeks (Laxative, Metoclopramide, Domperidone, Itopride, Levosulpride, Cisapride, Mosapride, Tegaserod, Prucalopride, Renzapride, Erythromycin, buspirone, Sumatriptan, Alosetron, Cilansetron, ondansetron, Citalopram, Paroxetine, Baclofen, Sildenafil, Nitroglycerin)
* Subjects who diagnosed lactulose malabsorption
* Subjects who diagnosed liver cirrhosis, severe congestive heart failure, severe renal insufficiency, uncontrolled hypertension, endocrine disorder, metabolic disorder, prior malignancy, immune deficiency
* Suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT02726295
Study Brief:
Protocol Section:
NCT02726295