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

NCT ID: NCT01707667

Last Updated: 2021-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-27
• Study Completion Date: 2013-11-27

Brief Summary

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

Conditions

Chronic Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prucalopride

Group Type: EXPERIMENTAL

prucalopride

Intervention Type: DRUG

One 2 mg tablet orally administered on Day 1

PEG 3350

Group Type: ACTIVE_COMPARATOR

PEG 3350

Intervention Type: DRUG

13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1(once in the morning and once prior to lunch).

Interventions

prucalopride

One 2 mg tablet orally administered on Day 1

Intervention Type: DRUG

PEG 3350

13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1(once in the morning and once prior to lunch).

Intervention Type: DRUG

Other Intervention Names

Resolor (Marketed name in Europe); Movicol

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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

Countries

United States; Belgium; United Kingdom

References

Miner PB Jr, Camilleri M, Burton D, Achenbach H, Wan H, Dragone J, Mellgard B. Prucalopride induces high-amplitude propagating contractions in the colon of patients with chronic constipation: a randomized study. Neurogastroenterol Motil. 2016 Sep;28(9):1341-8. doi: 10.1111/nmo.12832. Epub 2016 Jun 7.

Reference Type: DERIVED

PMID: 27270968 (View on PubMed)

Other Identifiers

2012-002495-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SPD555-403

Identifier Type: -

Identifier Source: org_study_id