Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Chronic Idiopathic Constipation

May 28, 2008 updated by: Movetis

A Double-Blind, Placebo-Controlled, Dose-Finding Trial to Evaluate the Efficacy and Safety of Prucalopride (R093877) in Subjects With Chronic Idiopathic Constipation

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

Hypothesis:

At all doses administered prucalopride given once daily for 4 weeks is safe and well tolerated in patients with chronic idiopathic constipation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a double-blind, placebo-controlled, randomized, parallel group, multicentre, Phase II, dose comparison trial, in which 313 subjects, with a history of chronic idiopathic constipation were enrolled. The trial was conducted in three phases:

  1. a 4-week drug-free run-in phase,
  2. a 4-week double-blind (DB) phase during which subjects were treated with R093877 (0.5 mg, 1 mg, 2 mg, or 4 mg capsule) or matching placebo once daily, prior to breakfast,
  3. a 4-week drug-free run-out phase (RO).

To qualify for the run-in phase (Visit 1, Week 1) subjects had to have experienced, for at least 3 months, 2 or less spontaneous, bowel movements (SBM)/week with the occurrence of lumpy (scyballae) and/or hard stools, a sensation of incomplete evacuation for at least a quarter of their stools, or straining during defecation at least a quarter of the time.

Study Type

Interventional

Enrollment (Actual)

313

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:

  • Male and non-pregnant female outsubjects between 18 and 70 years of age.

  • Documented history of constipation. The subject reports 2 or less SCBM/week with the occurrence of one or more of the following for at least 3 months before selection visit:

    • lumpy (scyballae) and/or hard stools at least a quarter of the stools;
    • sensation of incomplete evacuation following at least a quarter of the stools; or
    • straining at defecation at least a quarter of the time.

These criteria were only applicable for spontaneous, complete bowel movements, i.e., not preceded within a period of 24 hours by the intake of a laxative agent.

  • 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).
  • The subject's constipation was functional, i.e., idiopathic.
  • Written informed consent, signed by the subject and/or legal guardian and by the investigator.
  • Subject were available for follow-up during the trial period, as determined in the protocol.

Exclusion Criteria:

  • Subjects in whom constipation was thought to have been drug-induced.

  • Subject who suffered from types/causes of constipation other than idiopathic constipation, i.e.,presence of secondary causes of constipation including:

    • Endocrine disorders
    • Metabolic disorders
    • Neurologic disorders including:
  • Irritable bowel syndrome.
  • Subjects with congenital megacolon/megarectum or a diagnosis or pseudo-obstruction.
  • History of previous abdominal surgery (excluding hysterectomy, surgery for Meckel's diverticle,appendectomy, cholecystectomy, inguinal hernia repair, splenectomy, nephrectomy, fundoplication)thought to have been the primary cause of constipation.
  • Known or suspected organic disorders of the large bowel (i.e., obstruction, carcinoma, or inflammatory bowel disease). -Subjects with active proctological conditions thought to have been responsible for the constipation.

  • Subjects with ECG abnormalities including:

    • 2nd or 3rd degree AV block;
    • prolonged QTc intervals (> 460 msec); or
    • bradycardia (< or equal to 60 bpm).
  • Subjects who were receiving concomitant medication which could cause QT prolongation
  • Subjects on potassium-wasting diuretics.

  • Subjects with known illnesses or conditions such as:

    • severe cardiovascular or lung disease,
    • neurologic or psychiatric disorders (including active alcohol or drug abuse),
    • cancer,
    • AIDS, or
    • other gastrointestinal or endocrine disorders.
  • Subjects with impaired renal function
  • Subjects with a serum amylase, AST (SGOT), or ALT (SGPT) concentration >2 times the normal limit.
  • Subjects with clinically significant abnormalities of hematology, urinalysis or blood chemistry.
  • Females of childbearing potential without adequate contraceptive protection during the trial. Oral
  • Females who were pregnant or lactating.
  • Subjects who received an investigational drug in the 30 days preceding the run-in phase of this trial.
  • Subjects who were unable or unwilling to return for required follow-up visits.
  • Subjects whose reliability or physical state hindered adequate participation in a clinical trial.
  • Subjects who had polyps discovered during the screening colonoscopy that were untreated (i.e., by polypectomy). Subjects who had polyps during the screening colonoscopy that were treated by polypectomy were allowed to enter the trial after the 4-week healing period. Any subject with polyp(s)documented to contain an invasive carcinoma (Duke's B or greater) was excluded from this 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
Active Comparator: 1
0,5 mg prucalopride
Drug: prucalopride
0,5 mg once daily
Other Names:
  • Resolor
Drug: prucalopride
1 mg once daily
Other Names:
  • Resolor
Active Comparator: 2
1 mg prucalopride
Drug: prucalopride
0,5 mg once daily
Other Names:
  • Resolor
Drug: prucalopride
1 mg once daily
Other Names:
  • Resolor
Active Comparator: 3
2 mg prucalopride
Drug: 2 mg prucalopride
2 mg once daily
Other Names:
  • Resolor
Placebo Comparator: 5
Placebo arm
Other: Placebo
placebo once daily
Active Comparator: 4
4 mg prucalopride
Drug: 4 mg prucalopride
4 mg once daily
Other Names:
  • Resolor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the optimal dose of R093877 for the treatment of chronic idiopathic constipation by comparing the efficacy and safety of 0.5 mg, 1 mg, 2 mg, and 4 mg of R093877 versus placebo given orally once daily for 4 weeks.
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the effects of R093877 on symptoms associated with idiopathic constipation
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: Trent Nichols, MD, Hanover General 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

September 1, 1996

Primary Completion (Actual)

June 1, 1997

Study Completion (Actual)

June 1, 1997

Study Registration Dates

First Submitted

January 8, 2008

First Submitted That Met QC Criteria

January 16, 2008

First Posted (Estimate)

January 17, 2008

Study Record Updates

Last Update Posted (Estimate)

May 29, 2008

Last Update Submitted That Met QC Criteria

May 28, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRU-USA-3

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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