Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity
Completed · Phase 4
Conditions studied: Chronic Constipation
In brief
To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor activity in subjects that are chronically constipated.
Key facts
- Study ID
- NCT01707667
- Run by
- Shire
- People needed
- 13
- Starts
- 2013-02-27
- Expected to finish
- 2013-11-27
- Last updated by the study team
- 2021-07-02
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Chronic constipation
- Male or female ages 18-75 years
- Non-pregnant, non-lactating female
You may not qualify if…
- 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
Where it is running
- Oklahoma Foundation for Digestive Research — Oklahoma City, Oklahoma, United States
- UNIVERSITY OF LEUVEN, UNVERSITY HOSPITAL, Gasthuisberg — Leuven, Belgium
- Barts Health NHS Trust — Whitechapel, London, United Kingdom
Full record on ClinicalTrials.gov
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