Efficacy and Safety Study of Prucalopride to Treat Chronic Constipation

This study has been completed.
Sponsor:
Information provided by:
Movetis
ClinicalTrials.gov Identifier:
NCT00488137
First received: June 15, 2007
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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

Hypothesis:

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
Constipation
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: 716
Study Start Date: March 1998
Study Completion Date: July 1999
Primary Completion Date: July 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
Placebo
Other: Placebo
o.d.
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 At the start of this period, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial.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 should be taken or enemas used within 48 hours prior to the start of the double-blind treatment (48 hours prior to visit 2) and 48 hours following the start of double-blind treatment (48 hours following visit 2). 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.

  Eligibility

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

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 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 ClinicalTrials.gov identifier: NCT00488137

Sponsors and Collaborators
Movetis
Investigators
Principal Investigator: Ghislain Devroede, M.D. Centre Universitaire de Sante
  More Information

No publications provided by Movetis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Renate Specht Gryp, Movetis
ClinicalTrials.gov Identifier: NCT00488137     History of Changes
Other Study ID Numbers: PRU-INT-6
Study First Received: June 15, 2007
Last Updated: September 25, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Movetis:
constipation
prucalopride
QOL
SCBM
PAC-SYM

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014