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

Shire

Status and phase: Completed; Phase 4

Conditions: Chronic Constipation

Treatments: Drug: PEG 3350; Drug: prucalopride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01707667

2012-002495-13 (EudraCT Number)

SPD555-403

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

13 participants in 2 patient groups

Prucalopride

Experimental group

Treatment:

Drug: prucalopride

PEG 3350

Active Comparator group

Treatment:

Drug: PEG 3350