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

May 28, 2008 updated by: Movetis

A Double-Blind Placebo-Controlled Dose-Finding Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Chronic Idiopathic Constipation

The purpose of this study is to determine which dose of prucalopride is safe and effective in patients with chronic constipation.

Hypothesis:

Prucalopride 1 and 2 mg bid are safe and effective for the treatment of chronic constipation whereas 0,5 mg is a suboptimal dose.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a phase II trial with a parallel-group design, consisting of a drug-free run-in phase (phase 1), followed by a placebo controlled double-blind phase (phase 2). Patients will receive either R093877 0.5 mg b.i.d., 1 mg b.i.d. or 2 mg b.i.d. or placebo for a period of 12 weeks.

Phase 1 is a run-in period of 4 weeks duration, during which the bowel habit is documented and the existence of constipation confirmed. At the start of this period all existing laxative medication is withdrawn and patients will be instructed not to change their dietary habits, in particular their fiber intake during the trial. Patients will enter the double-blind phase if constipation has been shown to be present during the run-in period.

If the definition of constipation was not met during the 4 weeks of the run-in period, the patient will be considered ineligible for the double-blind period.

Phase 2 is a double-blind, randomized, placebo-controlled phase, in which patients will be treated for 12 weeks with either 0.5 mg, 1 mg or 2 mg of R093877 or placebo given twice daily (one capsule is taken before breakfast and one is to be taken before the evening meal).

Patients admitted to the double blind treatment period will be randomly allocated to one of the 4 treatment arms.

Study Type

Interventional

Enrollment (Actual)

253

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 18-70 years;

  2. History of constipation, i.e., the subject reported the occurrence of two or more of the following criteria for at least 6 months before the selection visit:

    • two or fewer spontaneous* bowel movements a week,
    • lumpy (scyballae) and/or hard stools at least ¼ of the stools,
    • sensation of incomplete evacuation after at least ¼ of the stools,
    • straining at defaecation at least ¼ of the time. *The above criteria were only applicable for spontaneous bowel movements i.e., not preceded within a 24-hour period by the intake of a laxative agent. Subjects who never had a spontaneous bowel movement were considered constipated and eligible to enter the double-blind phase of the trial.
  3. Constipation being severe and causing disability; the subject's occupational, social and recreational activities were governed by his/her constipation and efforts to attain relief;
  4. Normal inhibition pattern of the external anal sphincter during straining i.e., relaxation of the m.puborectalis and a distal displacement of the rectal canal (digital examination and/or electromyographic and/or manometric evidence was acceptable);
  5. Poor results with routine laxative treatment and diet counselling;
  6. Constipation of a functional, i.e., idiopathic nature;
  7. Written or oral witnessed informed consent;
  8. Availability for follow-up during the trial period.

Exclusion Criteria:

  1. Constipation thought to be drug-induced;
  2. Presence of secondary causes of constipation, i.e., subjects suffering from types or causes of constipation other than idiopathic constipation, for instance: endocrine disorders, metabolic disorders, or neurologic disorders;
  3. Congenital megacolon/megarectum;
  4. 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;
  5. Known or suspected organic disorders of the large bowel, i.e., obstruction, carcinoma or inflammatory bowel disease;
  6. Active proctological conditions thought to be responsible for the constipation;

  7. Presence of the following ECG abnormalities:

    • 2nd or 3rd degree of AV-block,
    • prolonged QT-times (> 460 ms),
    • bradycardia;
  8. Use of concomitant medication that might cause QT-prolongation;
  9. Use of diuretics not associated with potassium sparing effects;
  10. Known illnesses or conditions such as severe cardiovascular or lung disease, neurologic or psychiatric disorders (including substance abused dependence but with the exception of nicotine), alcoholism, cancer or AIDS and other gastrointestinal or endocrine disorders;
  11. Impaired renal function;
  12. Presence of a serum amylase, a serum glutamic-oxaloacetic transaminase (SGOT) or a serum glutamic-pyruvic transaminase (SGPT) concentration of > 2 times the normal limit;
  13. Presence of clinically significant abnormalities of blood chemistry, other than those mentioned under 9-10, haematology or urinalysis at selection;
  14. Pregnancy or wish to become pregnant during the trial. ;
  15. Breast-feeding;
  16. Investigational drug received in the 30 days preceding the trial;
  17. Inability or unwillingness to return for required follow-up visits;
  18. Reliability and physical state preventing proper evaluation of a drug 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: 4
Drug: Placebo
bid
Active Comparator: 1
Prucalopride 0.5 mg
Drug: Prucalopride
0.5 mg bid
Other Names:
  • Resolor
Drug: Prucalopride
1 mg bid
Other Names:
  • Resolor
Drug: Prucalopride
2 mg bid
Other Names:
  • Resolor
Active Comparator: 2
Prucalopride 1 mg
Drug: Prucalopride
0.5 mg bid
Other Names:
  • Resolor
Drug: Prucalopride
1 mg bid
Other Names:
  • Resolor
Drug: Prucalopride
2 mg bid
Other Names:
  • Resolor
Active Comparator: 3
Prucalopride 2 mg
Drug: Prucalopride
0.5 mg bid
Other Names:
  • Resolor
Drug: Prucalopride
1 mg bid
Other Names:
  • Resolor
Drug: Prucalopride
2 mg bid
Other Names:
  • Resolor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the efficacy and to compare the effects of 0.5 mg, 1 mg or 2 mg of R093877 versus placebo
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the effects of R093877 on symptoms associated with chronic constipation
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: P. Van Eeghem, MD, Onze Lieve Vrouw 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

November 1, 1995

Primary Completion (Actual)

April 1, 1997

Study Completion (Actual)

April 1, 1997

Study Registration Dates

First Submitted

February 6, 2008

First Submitted That Met QC Criteria

March 7, 2008

First Posted (Estimate)

March 10, 2008

Study Record Updates

Last Update Posted (Estimate)

May 29, 2008

Last Update Submitted That Met QC Criteria

May 28, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRU-INT-2

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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