Prucalopride in Patients With Chronic Idiopathic Constipation

This study has been completed.
Sponsor:
Information provided by:
Movetis
ClinicalTrials.gov Identifier:
NCT00575614
First received: December 17, 2007
Last updated: May 28, 2008
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Constipation
Drug: prucalopride
Drug: placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Movetis:

Primary Outcome Measures:
  • Whole gut transit [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ano-rectal physiology [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: April 1997
Study Completion Date: March 1999
Primary Completion Date: March 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: prucalopride
1 mg o.d.
Other Name: Resolor
Placebo Comparator: 2 Drug: placebo
o.d.

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).

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575614

Sponsors and Collaborators
Movetis
Investigators
Principal Investigator: Michael Kamm, MD Northwick Park Hospital
  More Information

Publications:
Responsible Party: Renate Specht Gryp, Movetis
ClinicalTrials.gov Identifier: NCT00575614     History of Changes
Other Study ID Numbers: GBR-4
Study First Received: December 17, 2007
Last Updated: May 28, 2008
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Movetis:
Constipation
Prucalopride
Ano-rectal physiology
Oro-caecal transit time
QOL

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

ClinicalTrials.gov processed this record on April 23, 2014