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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT02030756
Eligibility Criteria:
Inclusion Criteria:
1. Patients aged 18 years and older.
2. Patients with chronic idiopathic constipation according to Rome III criteria and who have not experienced relief of their symptoms from available therapies (osmotic and stimulant laxatives which was used for at least one month at recommended dose).
3. Patients with more than 1 bowel movement/2 weeks and \< 3 bowel movement/week.
4. Colonoscopy performed in the past 10 years prior to study participation, unless the patients are \<50 years old and without alarming signs and symptoms
5. Patient signed ICF
6. For women with childbearing potential, adequate contraception
Exclusion Criteria:
1. History of complicated/obstructive diverticular disease
2. History of intestinal or colonic obstruction.
3. History of significant GI disorder.
4. Use of following medication: Medication that may affect the bowel mobility, Prokinetics, Anti-Depressants, medications for treatment of Parkinson disease, Opiates, Calcium-channel Blockers, Aluminium/Magnesium Hydroxids
5. Clinical evidence of significant respiratory, CVS, renal, hepatic, biliary, endocrine, psychiatric, neurologic, or presence of abdominal pacemakers.
6. Presence of pacemaker.
7. History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.
8. Diagnosis of mega-rectum or colon, a history of intestinal obstruction, congenital anorectal malformation, clinically significant rectocele, or any evidence of intestinal structural abnormality, including GI resection that affects bowel transit, or any evidence of intestinal carcinoma or inflammatory bowel disease of alarm symptoms such as weight loss, rectal bleeding, or anaemia.
9. History of Zenker's diverticulum, dysphagia or a known esophageal stricture 10. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
11\. Participation in another clinical study in the last 4 months prior to screening.
12\. Any other condition which in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the clinical study.
13\. Women who are pregnant or lactating.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02030756
Study Brief:
Protocol Section:
NCT02030756