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Efficacy and Safety Study of Prucalopride for the Treatment of Chronic Constipation

This study has been completed.
Information provided by:
Movetis Identifier:
First received: June 6, 2007
Last updated: April 10, 2013
Last verified: April 2013

The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation.


Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the treatment of patients with chronic constipation and is well tolerated in those patients.

Condition Intervention Phase
Drug: Prucalopride
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride (R108512) Tablets in Subjects With Chronic Constipation.

Resource links provided by NLM:

Further study details as provided by Movetis:

Primary Outcome Measures:
  • Proportion of subjects with an average of 3 or more SCBM per week [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary efficacy variables: 1) Symptom variables 2) QOL variables [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 620
Study Start Date: April 1998
Study Completion Date: May 1999
Primary Completion Date: May 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Prucalopride 2 mg
Drug: Prucalopride
2 mg o.d.
Other Name: Resolor
Placebo Comparator: 3
Other: Placebo
Placebo o.d.
Other Name: N.A.
Active Comparator: 2
Prucalopride 4 mg
Drug: Prucalopride
4 mg o.d.
Other Name: Resolor

Detailed Description:

This is a multicentre, Phase III trial with a parallel-group design, consisting of a 2 week drug-free run-in period, followed by a 12-week, double-blind, placebo-controlled treatment period.

During the run-in period, the subject's bowel habit will be documented and the existence of constipation confirmed. At the start of this period, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial. Subjects will be allowed to take a laxative (Dulcolax) as a rescue medication throughout the trial, but only if they have not had a bowel movement for three or more consecutive days. No Dulcolax or enemas should be taken within 48 hours prior to the start of double-blind treatment and 48 hours following the start of double-blind treatment. Subjects will enter the double-blind period if constipation is shown to be present during the run-in period.

If the definition of constipation is not met during the 2-week run-in, the subject will be considered ineligible for the double-blind period and will be discontinued from the study.

During the double-blind, randomised, placebo-controlled period, subjects will be treated for 12 weeks with either 2 mg or 4 mg R108512 or placebo, given once daily before breakfast.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 1. Male and non-pregnant, non breast-feeding female outpatients at least 18 years of age (no upper age limit).
  • 2. History of constipation; the subject reports, on average, two or fewer spontaneous bowel movements per week that result in a feeling of complete evacuation and or one or more of the following for at least 6 months before the selection visit:

    1. very hard (little balls) and/or hard stools at least a quarter of the stools
    2. sensation of incomplete evacuation following at least a quarter of the stools
    3. straining at defecation at least a quarter of the time. The above criteria are only applicable for spontaneous bowel movements, i.e., not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.

Subjects who never have spontaneous bowel movements are considered to be constipated and are eligible for the trial.

Exclusion Criteria:

  • 1. Subjects in whom constipation is thought to be drug-induced, or subjects using any disallowed medication.
  • 2. Subjects suffering from endocrine disorders, metabolic disorders or neurologic disorders.
  • 3. Subjects with a megacolon/megarectum or a diagnosis of pseudo-obstruction.
  • 4. Constipation as a result of surgery.
  • 5. Known or suspected organic disorders of the large bowel, i.e. obstruction, carcinoma, or inflammatory bowel disease.
  • 6. Subjects with severe and clinically uncontrolled cardiovascular, liver, or lung disease, neurologic or psychiatric disorders (including active alcohol or drug abuse), cancer or AIDS, and other gastrointestinal or endocrine disorders.
  • 7. Subjects with impaired renal function.
  • 8. Subjects with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
  • 9. Females of child-bearing potential without adequate contraceptive protection during the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00483886

Sponsors and Collaborators
Principal Investigator: Michael Camilleri, M.D. Mayo Graduate School of Medicine
  More Information

No publications provided by Movetis

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Renate Specht Gryp, Movetis Identifier: NCT00483886     History of Changes
Other Study ID Numbers: PRU-USA-11
Study First Received: June 6, 2007
Last Updated: April 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Movetis:

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive processed this record on March 01, 2015