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Evaluation of the Safety and Tolerability of Prucalopride in Constipated Elderly Subjects Living in a Nursing Facility

NCT ID: NCT00627692

Last Updated: 2008-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-02-28

Study Completion Date

2000-05-31

Brief Summary

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The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of constipation in elderly subjects living in a nursing facility.

Hypothesis:

Prucalopride up to a dose of 4 mg once daily is safe and well tolerated in in elderly subjects living in a nursing facility.

Detailed Description

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This is a multicenter, Phase II, dose-escalation trial with a 4 week double-blind, placebo-controlled treatment period. There will be four treatment cohorts (0.5 mg, 1 mg, 2 mg, or 4 mg) with 25 subjects in each. The first cohort of 25 subjects will be randomly assigned to receive either 0.5 mg R108512 or placebo in a 4 to 1 ratio, respectively, for four weeks. After two weeks of treatment, the safety and tolerability of this dose will be evaluated for each subject by an independent (external) safety committee. If, at the completion of treatment, the safety committee grants approval to proceed to a higher dose, the second cohort will be randomly assigned to receive either 1 mg R108512 or placebo for four weeks. In a likewise manner, each dose will be evaluated for safety and tolerability before the next cohort will be treated with a higher dose. No subject can participate in more than one treatment cohort.

Subjects will be instructed not to change their diet or lifestyle during the trial. Subjects will be allowed to continue the use of routine stool softeners and fiber supplements during the trial; however, all existing stimulant or osmotic laxative medication will be withdrawn. If, during the trial, the subject does not have a complete bowel movement for three or more consecutive days, he/she will be allowed the use of his/her usual stimulant or osmotic laxative or an enema as a rescue medication. No laxatives or enemas should be used within the 24 hours before and 24 hours after the start of double-blind treatment.

Conditions

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Constipation

Keywords

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Constipation in elderly patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Prucalopride

Group Type ACTIVE_COMPARATOR

Prucalopride

Intervention Type DRUG

0.5 mg o.d.

2

Prucalopride

Group Type ACTIVE_COMPARATOR

Prucalopride

Intervention Type DRUG

1 mg o.d.

3

Prucalopride

Group Type ACTIVE_COMPARATOR

Prucalopride

Intervention Type DRUG

2 mg o.d.

5

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

o.d.

4

Prucalopride

Group Type ACTIVE_COMPARATOR

Prucalopride

Intervention Type DRUG

4 mg o.d.

Interventions

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Prucalopride

0.5 mg o.d.

Intervention Type DRUG

Placebo

o.d.

Intervention Type OTHER

Prucalopride

1 mg o.d.

Intervention Type DRUG

Prucalopride

2 mg o.d.

Intervention Type DRUG

Prucalopride

4 mg o.d.

Intervention Type DRUG

Other Intervention Names

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Eligibility Criteria

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Inclusion Criteria

1. Male and female patients at least 65 years of age (no upper age limit).
2. History of constipation. i.e., the patient should have received any treatment for constipation at any time during the 4 weeks (28 days) preceding entry into the study, including fibre/bulk forming supplements.
3. The patient had to live in a nursing facility.
4. The patient had to be clinically stable.
5. The patient had to be able to take oral medications.
6. The patient had to be continent of bowels the majority of time.
7. The patient had to be able to reliably communicate AEs.
8. The patient had to provide informed consent, signed by the patient or legally acceptable representative and by the investigator.

Exclusion Criteria

1. Patients who were known to be HIV positive or who had AIDS.
2. Patients who were being actively treated with Propulsid (cisapride) or cancer chemotherapy other than hormonal agents.
3. Patients with significantly impaired renal function, i.e., creatinine clearance \<30 mL/min using the Cockcroft and Gault formula:

Males: CLCR = \[(140-age) x (weight in kg)\] / 72 x (SCR).

Females: CLCR = male value x 0.85

Because the calculated value for creatinine clearance could be artificially high when serum creatinine concentrations were very low, patients with a serum creatinine \<0.5 mg/dL were excluded from the study.
4. Patients who received an investigational drug in the 30 days preceding the study.
5. Patients who had previously received either R093877 or R108512.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Movetis

INDUSTRY

Sponsor Role lead

Responsible Party

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Movetis

Principal Investigators

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D O'Neill, MD

Role: PRINCIPAL_INVESTIGATOR

Riverside Regional Convalescent Center

References

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Camilleri M, Beyens G, Kerstens R, Robinson P, Vandeplassche L. Safety assessment of prucalopride in elderly patients with constipation: a double-blind, placebo-controlled study. Neurogastroenterol Motil. 2009 Dec;21(12):1256-e117. doi: 10.1111/j.1365-2982.2009.01398.x. Epub 2009 Sep 9.

Reference Type DERIVED
PMID: 19751247 (View on PubMed)

Other Identifiers

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PRU-USA-26

Identifier Type: -

Identifier Source: org_study_id