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

• Status: Completed
• Trial end date: 2013-11-27
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Polyethylene glycol 3350; Prucalopride

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