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Efficacy and Safety Study of Prucalopride to Treat Chronic Constipation

Primary Purpose

Constipation

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Prucalopride

Placebo

Prucalopride

About this trial

This is an interventional treatment trial for Constipation focused on measuring constipation, prucalopride, QOL, SCBM, PAC-SYM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and non-pregnant, non breast-feeding female outpatients at least 18 years of age (no upper age limit).
History of constipation; the subject reports, on average, two or fewer spontaneous bowel movements per week that result in a feeling of complete evacuation and one or more of the following for at least 6 months before the selection visit:
1. very hard (little balls) and/or hard stools at least a quarter of the stools
2. sensation of incomplete evacuation following at least a quarter of the stools
3. straining at defecation at least a quarter of the time. The above criteria are only applicable for spontaneous bowel movements, i.e., not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.

Subjects who never have spontaneous bowel movements are considered to be constipated and are eligible for the trial.

Exclusion Criteria:

Subjects in whom constipation is thought to be drug-induced, or subjects using any disallowed medication.
Subjects suffering from endocrine disorders, metabolic disorders or neurologic disorders.
Subjects with a megacolon/megarectum or a diagnosis of pseudo-obstruction.
Constipation as a result of surgery.
Known or suspected organic disorders of the large bowel, i.e. obstruction, carcinoma, or inflammatory bowel disease.
Subjects with severe and clinically uncontrolled cardiovascular, liver, or lung disease, neurologic or psychiatric disorders (including active alcohol or drug abuse), cancer or AIDS, and other gastrointestinal or endocrine disorders.
Subjects with impaired renal function.
Subjects with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
Females of child-bearing potential without adequate contraceptive protection during the trial.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Arm Description

Prucalopride 2 mg

Placebo

Prucalopride 4 mg

Outcomes

Primary Outcome Measures

Proportion of subjects with an average of 3 or more SCBM per week

Secondary Outcome Measures

Secondary efficacy variables: 1) Symptom variables 2) QOL variables

Full Information

NCT ID

NCT00488137

First Posted

June 15, 2007

Last Updated

September 25, 2013

Sponsor

Movetis

1. Study Identification

Unique Protocol Identification Number

NCT00488137

Brief Title

Efficacy and Safety Study of Prucalopride to Treat Chronic Constipation

Official Title

A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride (R108512) Tablets in Subjects With Chronic Constipation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

March 1998 (undefined)

Primary Completion Date

July 1999 (Actual)

Study Completion Date

July 1999 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Movetis

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation. Hypothesis: Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the treatment of patients with chronic constipation and is well tolerated in those patients

Detailed Description

This is a multicentre, Phase III trial with a parallel-group design, consisting of a 2 week drug-free run-in period, followed by a 12-week, double-blind, placebo-controlled treatment period. During the run-in period, the subject's bowel habit will be documented and the existence of constipation confirmed. At the start of this period, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial. Subjects will be allowed to take a laxative (Dulcolax) as a rescue medication throughout the trial, but only if they have not had a bowel movement for three or more consecutive days. No Dulcolax should be taken or enemas used within 48 hours prior to the start of the double-blind treatment (48 hours prior to visit 2) and 48 hours following the start of double-blind treatment (48 hours following visit 2). Subjects will enter the double-blind period if constipation is shown to be present during the run-in period. If the definition of constipation is not met during the 2-week run-in, the subject will be considered ineligible for the double-blind period and will be discontinued from the study. During the double-blind, randomised, placebo-controlled period, subjects will be treated for 12 weeks with either 2 mg or 4 mg R108512 or placebo, given once daily before breakfast.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation

Keywords

constipation, prucalopride, QOL, SCBM, PAC-SYM

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

716 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Prucalopride 2 mg

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Arm Type

Active Comparator

Arm Description

Prucalopride 4 mg

Intervention Type

Drug

Intervention Name(s)

Prucalopride

Other Intervention Name(s)

Resolor

Intervention Description

2 mg o.d.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

o.d.

Intervention Type

Drug

Intervention Name(s)

Prucalopride

Other Intervention Name(s)

Resolor

Intervention Description

4 mg o.d.

Primary Outcome Measure Information:

Title

Proportion of subjects with an average of 3 or more SCBM per week

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Secondary efficacy variables: 1) Symptom variables 2) QOL variables

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and non-pregnant, non breast-feeding female outpatients at least 18 years of age (no upper age limit). History of constipation; the subject reports, on average, two or fewer spontaneous bowel movements per week that result in a feeling of complete evacuation and one or more of the following for at least 6 months before the selection visit: very hard (little balls) and/or hard stools at least a quarter of the stools sensation of incomplete evacuation following at least a quarter of the stools straining at defecation at least a quarter of the time. The above criteria are only applicable for spontaneous bowel movements, i.e., not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema. Subjects who never have spontaneous bowel movements are considered to be constipated and are eligible for the trial. Exclusion Criteria: Subjects in whom constipation is thought to be drug-induced, or subjects using any disallowed medication. Subjects suffering from endocrine disorders, metabolic disorders or neurologic disorders. Subjects with a megacolon/megarectum or a diagnosis of pseudo-obstruction. Constipation as a result of surgery. Known or suspected organic disorders of the large bowel, i.e. obstruction, carcinoma, or inflammatory bowel disease. Subjects with severe and clinically uncontrolled cardiovascular, liver, or lung disease, neurologic or psychiatric disorders (including active alcohol or drug abuse), cancer or AIDS, and other gastrointestinal or endocrine disorders. Subjects with impaired renal function. Subjects with clinically significant abnormalities of haematology, urinalysis, or blood chemistry. Females of child-bearing potential without adequate contraceptive protection during the trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ghislain Devroede, M.D.

Organizational Affiliation

Centre Universitaire de Sante

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

24032987

Citation

Broad J, Kung VW, Boundouki G, Aziz Q, De Maeyer JH, Knowles CH, Sanger GJ. Cholinergic interactions between donepezil and prucalopride in human colon: potential to treat severe intestinal dysmotility. Br J Pharmacol. 2013 Nov;170(6):1253-61. doi: 10.1111/bph.12397.

Results Reference

background

PubMed Identifier

34585675

Citation

Staller K, Hinson J, Kerstens R, Spalding W, Lembo A. Efficacy of Prucalopride for Chronic Idiopathic Constipation: An Analysis of Participants With Moderate to Very Severe Abdominal Bloating. Am J Gastroenterol. 2022 Jan 1;117(1):184-188. doi: 10.14309/ajg.0000000000001521.

Results Reference

derived

PubMed Identifier

25581251

Citation

Tack J, Camilleri M, Dubois D, Vandeplassche L, Joseph A, Kerstens R. Association between health-related quality of life and symptoms in patients with chronic constipation: an integrated analysis of three phase 3 trials of prucalopride. Neurogastroenterol Motil. 2015 Mar;27(3):397-405. doi: 10.1111/nmo.12505. Epub 2015 Jan 11.

Results Reference

derived

PubMed Identifier

24106924

Citation

Tack J, Stanghellini V, Dubois D, Joseph A, Vandeplassche L, Kerstens R. Effect of prucalopride on symptoms of chronic constipation. Neurogastroenterol Motil. 2014 Jan;26(1):21-7. doi: 10.1111/nmo.12217. Epub 2013 Sep 20.

Results Reference

derived

PubMed Identifier

24917940

Citation

Tack J, Quigley E, Camilleri M, Vandeplassche L, Kerstens R. Efficacy and safety of oral prucalopride in women with chronic constipation in whom laxatives have failed: an integrated analysis. United European Gastroenterol J. 2013 Feb;1(1):48-59. doi: 10.1177/2050640612474651.

Results Reference

derived

PubMed Identifier

18987031

Citation

Tack J, van Outryve M, Beyens G, Kerstens R, Vandeplassche L. Prucalopride (Resolor) in the treatment of severe chronic constipation in patients dissatisfied with laxatives. Gut. 2009 Mar;58(3):357-65. doi: 10.1136/gut.2008.162404. Epub 2008 Nov 5. Erratum In: Gut. 2012 Sep;61(9):1298.

Results Reference

derived

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Efficacy and Safety Study of Prucalopride to Treat Chronic Constipation

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