Back to results

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

Primary Purpose

Constipation

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Prucalopride

Placebo

Prucalopride

About this trial

This is an interventional treatment trial for Constipation focused on measuring Constipation in elderly patients

Eligibility Criteria

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

Inclusion Criteria:

Male and female patients at least 65 years of age (no upper age limit).
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.
The patient had to live in a nursing facility.
The patient had to be clinically stable.
The patient had to be able to take oral medications.
The patient had to be continent of bowels the majority of time.
The patient had to be able to reliably communicate AEs.
The patient had to provide informed consent, signed by the patient or legally acceptable representative and by the investigator.

Exclusion Criteria:

Patients who were known to be HIV positive or who had AIDS.
Patients who were being actively treated with Propulsid (cisapride) or cancer chemotherapy other than hormonal agents.
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.
Patients who received an investigational drug in the 30 days preceding the study.
Patients who had previously received either R093877 or R108512.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Arm Description

Prucalopride

Placebo

Prucalopride

Outcomes

Primary Outcome Measures

Patient's Global Assessment of severity of constipation and efficacy of treatment evaluated (for exploratory reasons only).

Secondary Outcome Measures

Patient's symptom assessment(evaluated for exploratory reasons only).

Full Information

NCT ID

NCT00627692

First Posted

February 21, 2008

Last Updated

May 28, 2008

Sponsor

Movetis

1. Study Identification

Unique Protocol Identification Number

NCT00627692

Brief Title

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

Official Title

A Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Tolerability of Oral Once-Daily Prucalopride (R108512) Solution in Constipated Elderly Subjects Living in a Nursing Facility

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

February 1999 (undefined)

Primary Completion Date

May 2000 (Actual)

Study Completion Date

May 2000 (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 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

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.

6. Conditions and Keywords

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

Constipation

Keywords

Constipation in elderly patients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (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

Active Comparator

Arm Description

Prucalopride

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Arm Type

Active Comparator

Arm Description

Prucalopride

Intervention Type

Drug

Intervention Name(s)

Prucalopride

Other Intervention Name(s)

Resolor

Intervention Description

0.5 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

1 mg o.d.

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.

Primary Outcome Measure Information:

Title

Patient's Global Assessment of severity of constipation and efficacy of treatment evaluated (for exploratory reasons only).

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Patient's symptom assessment(evaluated for exploratory reasons only).

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female patients at least 65 years of age (no upper age limit). 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. The patient had to live in a nursing facility. The patient had to be clinically stable. The patient had to be able to take oral medications. The patient had to be continent of bowels the majority of time. The patient had to be able to reliably communicate AEs. The patient had to provide informed consent, signed by the patient or legally acceptable representative and by the investigator. Exclusion Criteria: Patients who were known to be HIV positive or who had AIDS. Patients who were being actively treated with Propulsid (cisapride) or cancer chemotherapy other than hormonal agents. 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. Patients who received an investigational drug in the 30 days preceding the study. Patients who had previously received either R093877 or R108512.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

D O'Neill, MD

Organizational Affiliation

Riverside Regional Convalescent Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

19751247

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs