Prucalopride in Patients With Chronic Idiopathic Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00575614
Recruitment Status : Completed
First Posted : December 18, 2007
Last Update Posted : May 29, 2008
Information provided by:

Brief Summary:

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


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 or disease Intervention/treatment Phase
Constipation Drug: prucalopride Drug: placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 1997
Actual Primary Completion Date : March 1999
Actual Study Completion Date : March 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Active Comparator: 1 Drug: prucalopride
1 mg o.d.
Other Name: Resolor

Placebo Comparator: 2 Drug: placebo

Primary Outcome Measures :
  1. Whole gut transit [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Ano-rectal physiology [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00575614

Sponsors and Collaborators
Principal Investigator: Michael Kamm, MD Northwick Park Hospital

Publications of Results:
Responsible Party: Renate Specht Gryp, Movetis Identifier: NCT00575614     History of Changes
Other Study ID Numbers: GBR-4
First Posted: December 18, 2007    Key Record Dates
Last Update Posted: May 29, 2008
Last Verified: December 2007

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

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