Prucalopride in Patients With Chronic Idiopathic Constipation

May 28, 2008 updated by: Movetis

Study to Evaluate the Effect of a 1 mg o.d. Dose of Prucalopride in Patients With Chronic Idiopathic Constipation

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

Hypothesis:

Prucalopride given at a dose of 1 mg o.d. for 4 weeks to female patients with chronic constipation shows a favourable effect on most of the efficacy parameters assessed in this trial. This dosage can be considered safe and generally well-tolerated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, placebo-controlled, parallel-group, phase II trial set up to investigate the efficacy, safety and physiological effects of prucalopride 1 mg administered o.d. for 4 weeks to female patients with chronic idiopathic constipation. The primary objective of this trial was to assess the effect of prucalopride 1 mg on whole gut transit (measured as changes from baseline in total number of markers).

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 2

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

Female

Description

Inclusion Criteria:

  • female subjects of 18 years or over;
  • history of chronic constipation during at least 6 months before selection, characterized by either two or fewer spontaneous (ie, without using laxatives) bowel movements in a week or straining at defaecation at least a quarter of the time;
  • written informed consent;
  • within 20% of her body weight as specified in the Metropolitan Life Insurance Company's 1983 Height and Weight Table2;
  • healthy on the basis of a pre-trial physical examination, medical history, anamnesis,electrocardiogram and the results of biochemistry, haematology and urinalysis, carried out within 3 weeks of randomization. If the results of the laboratory tests were not within the reference ranges, the subject could only be included on condition that the investigator did not judge the deviations to be clinically relevant.

Exclusion Criteria:

  • use of disallowed concomitant medication;
  • subjects who had undergone surgery for their constipation;
  • subjects with faecal impaction;
  • subjects suffering from different types or causes of constipation other than idiopathic constipation, ie, presence of secondary causes, eg, endocrine disorders, metabolic disorders, neurologic disorders;
  • subjects with a megacolon/megarectum;
  • subjects with external rectal prolapse;
  • history of previous abdominal surgery (other than hysterectomy, surgery for Meckel's diverticle, appendectomy, cholecystectomy, inguinal hernia repair, splenectomy, nephrectomy or fundoplication) thought to be the primary cause of constipation;
  • known or suspected organic disorders of the large bowel, ie, obstruction, carcinoma or inflammatory bowel disease. If complaints of constipation were of recent onset, ie, had been present for less than one year, and the subject was 40 years or older, results of a Ba-enema or of colonoscopic examination were required;
  • subjects with solitary rectal ulcer (this had to be excluded by rigid sigmoidoscopic examination at the first visit);
  • subjects with active proctological conditions thought to be responsible for the constipation;
  • subjects with known illnesses or conditions such as: severe cardiovascular or lung disease, neurologic or psychiatric disorders (including substance abuse/dependence, but with the exception of nicotine), alcoholism, cancer or AIDS and other gastrointestinal or endocrine disorders;
  • subjects receiving, or who had received, care for an eating disorder;
  • subjects with impaired renal function;
  • subjects with a serum amylase, a serum glutamic-oxaloacetic transaminase (SGOT), or a serum glutamic-pyruvic transaminase (SGPT) concentration of > 2 times the normal limit;
  • pregnancy or wish to become pregnant in the course of the trial. Lack of an acceptable birth control method;
  • breast-feeding;
  • subjects who had received an investigational drug in the 30 days preceding the trial;
  • subjects who were unable or unwilling to return for required follow-up visits;
  • subjects whose reliability and physical state would prevent proper evaluation of a drug trial;
  • history or suspicion of alcohol or drug abuse.

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: 2
Drug: placebo
o.d.
Active Comparator: 1
Drug: prucalopride
1 mg o.d.
Other Names:
  • Resolor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Whole gut transit
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Ano-rectal physiology
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

Movetis

Investigators

  • Principal Investigator: Michael Kamm, MD, Northwick Park Hospital

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

April 1, 1997

Primary Completion (Actual)

March 1, 1999

Study Completion (Actual)

March 1, 1999

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

May 29, 2008

Last Update Submitted That Met QC Criteria

May 28, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GBR-4

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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