Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:11/30/2013
Start Date:January 2013
End Date:December 2013
Contact:Shire Call Center
Phone:+1 866-842-5335

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An Open-label, Randomized, Crossover, Reader-blinded Study to Investigate the Effect of Prucalopride and Polyethylene Glycol 3350 on Colon Motility With Intramural Manometry in Subjects With Chronic Constipation


To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor
activity in subjects that are chronically constipated.


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
We found this trial at
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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