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Efficacy and Safety Study of Prucalopride for the Treatment of Elderly Patients With Chronic Constipation

Primary Purpose

Constipation

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

prucalopride

Prucalopride

Placebo

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Male and female subjects of 65 or over 65 years of age.
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 stools. 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 the main complaint of abdominal pain.
Subjects with a known 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.
Malignancies or AIDS.
Known serious illnesses: clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric or metabolic disturbances. Patients with known diverticulosis may be included.
Subjects with a serum creatinine concentration > 2 mg/dL (> 180 micromol/L).
Subjects with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Prucalopride

Placebo

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

NCT00487422

First Posted

June 14, 2007

Last Updated

May 28, 2008

Sponsor

Movetis

1. Study Identification

Unique Protocol Identification Number

NCT00487422

Brief Title

Efficacy and Safety Study of Prucalopride for the Treatment of Elderly Patients With Chronic Constipation

Official Title

A Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Quality-of-Life of R108512 Tablets in Elderly Subjects With Chronic Constipation

Study Type

Interventional

2. Study Status

Record Verification Date

June 2007

Overall Recruitment Status

Completed

Study Start Date

October 1998 (undefined)

Primary Completion Date

September 1999 (Actual)

Study Completion Date

September 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 in elderly patients. 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, randomised, Phase III trial with a parallel-group design, consisting of a 2 week drug-free run-in period, followed by a 4-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. Subjects will enter the double-blind period if constipation is shown to be present during the run-in period. Patients will be randomly allocated to one of the 4 treatment arms: 1 mg, 2 mg, 4 mg of R108512 or placebo, with a 25% chance to each treatment group. During the double-blind period, subjects will be treated for 4 weeks with either 1 mg, 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

303 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Prucalopride

Arm Title

Arm Type

Active Comparator

Arm Description

Prucalopride

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

prucalopride

Other Intervention Name(s)

Resolor

Intervention Description

2 mg o.d.

Intervention Type

Drug

Intervention Name(s)

Prucalopride

Other Intervention Name(s)

Resolor

Intervention Description

4 mg o.d.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female subjects of 65 or over 65 years of age. 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 stools. 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 the main complaint of abdominal pain. Subjects with a known 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. Malignancies or AIDS. Known serious illnesses: clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric or metabolic disturbances. Patients with known diverticulosis may be included. Subjects with a serum creatinine concentration > 2 mg/dL (> 180 micromol/L). Subjects with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerald Demschik, M.D.

Organizational Affiliation

Geriatriezentrum am Wienerwald

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

20529205

Citation

Muller-Lissner S, Rykx A, Kerstens R, Vandeplassche L. A double-blind, placebo-controlled study of prucalopride in elderly patients with chronic constipation. Neurogastroenterol Motil. 2010 Sep;22(9):991-8, e255. doi: 10.1111/j.1365-2982.2010.01533.x. Epub 2010 Jun 7.

Results Reference

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Efficacy and Safety Study of Prucalopride for the Treatment of Elderly Patients With Chronic Constipation

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