Efficacy and Safety Study of Prucalopride to Treat Chronic Constipation

September 25, 2013 updated by: Movetis

A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride (R108512) Tablets in Subjects With Chronic Constipation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 At the start of this period, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial.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.

Study Type

Interventional

Enrollment (Actual)

716

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3
Placebo
Other: Placebo
o.d.
Active Comparator: 1
Prucalopride 2 mg
Drug: Prucalopride
2 mg o.d.
Other Names:
  • Resolor
Drug: Prucalopride
4 mg o.d.
Other Names:
  • Resolor
Active Comparator: 2
Prucalopride 4 mg
Drug: Prucalopride
2 mg o.d.
Other Names:
  • Resolor
Drug: Prucalopride
4 mg o.d.
Other Names:
  • Resolor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with an average of 3 or more SCBM per week
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary efficacy variables: 1) Symptom variables 2) QOL variables
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Movetis

Investigators

  • Principal Investigator: Ghislain Devroede, M.D., Centre Universitaire de Sante

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1998

Primary Completion (Actual)

July 1, 1999

Study Completion (Actual)

July 1, 1999

Study Registration Dates

First Submitted

June 15, 2007

First Submitted That Met QC Criteria

June 18, 2007

First Posted (Estimate)

June 19, 2007

Study Record Updates

Last Update Posted (Estimate)

September 26, 2013

Last Update Submitted That Met QC Criteria

September 25, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRU-INT-6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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