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

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