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:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT01707667
Eligibility Criteria:
Inclusion Criteria:
* Chronic constipation
* Male or female ages 18-75 years
* Non-pregnant, non-lactating female
Exclusion Criteria:
* Drug-induced constipation
* Subjects suffering from secondary causes of chronic constipation, such as:
* Endocrine disorders, e.g. hypopituitarism, hypothyroidism, hypercalcemia, pseudohypoparathyroidism, pheochromocytoma or glucagon-producing tumors, unless these are controlled by appropriate medical therapy.
* Metabolic disorders, e.g. porphyria, uremia, hypokalemia or amyloid neuropathy, unless these are controlled by appropriate medical therapy
* Neurological disorders, e.g. Parkinson's disease, cerebral tumors, cerebrovascular accidents, multiple sclerosis, meningocele, aganglionosis, hypoganglionosis, hyperganglionosis, autonomic neuropathy or neuropathy due to chemotherapy, spinal cord injury, Chaga's disease, or major depression
* Surgery.
* Subjects with insulin-dependent diabetes mellitus
* Rectal evacuation disorder/outlet obstruction
* Subjects with intestinal perforation or obstruction
* Severe renal impairment
* Subjects with a history of alcohol or drug abuse
* Subjects with lactose intolerance
* Subjects with clinically significant cardiac, vascular, liver, pulmonary, endocrine, neurological or psychiatric disorders
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01707667
Study Brief:
Protocol Section:
NCT01707667