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

May 28, 2008 updated by: Movetis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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and fiber supplements during the trial; however, all existing stimulant or osmotic laxative medication will be withdrawn.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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Prucalopride
Drug: Prucalopride
2 mg o.d.
Other Names:
  • Resolor
Drug: Prucalopride
4 mg o.d.
Other Names:
  • Resolor
Drug: Prucalopride
1 mg o.d.
Other Names:
  • Resolor
Drug: Prucalopride
0.5 mg o.d.
Other Names:
  • Resolor
ACTIVE_COMPARATOR: 2
Prucalopride
Drug: Prucalopride
2 mg o.d.
Other Names:
  • Resolor
Drug: Prucalopride
4 mg o.d.
Other Names:
  • Resolor
Drug: Prucalopride
1 mg o.d.
Other Names:
  • Resolor
Drug: Prucalopride
0.5 mg o.d.
Other Names:
  • Resolor
ACTIVE_COMPARATOR: 3
Prucalopride
Drug: Prucalopride
2 mg o.d.
Other Names:
  • Resolor
Drug: Prucalopride
4 mg o.d.
Other Names:
  • Resolor
Drug: Prucalopride
1 mg o.d.
Other Names:
  • Resolor
Drug: Prucalopride
0.5 mg o.d.
Other Names:
  • Resolor
PLACEBO_COMPARATOR: 5
Placebo
Other: Placebo
o.d.
ACTIVE_COMPARATOR: 4
Prucalopride
Drug: Prucalopride
2 mg o.d.
Other Names:
  • Resolor
Drug: Prucalopride
4 mg o.d.
Other Names:
  • Resolor
Drug: Prucalopride
1 mg o.d.
Other Names:
  • Resolor
Drug: Prucalopride
0.5 mg o.d.
Other Names:
  • Resolor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient's Global Assessment of severity of constipation and efficacy of treatment evaluated (for exploratory reasons only).
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient's symptom assessment(evaluated for exploratory reasons only).
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Movetis

Investigators

  • Principal Investigator: D O'Neill, MD, Riverside Regional Convalescent Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1999

Primary Completion (ACTUAL)

May 1, 2000

Study Completion (ACTUAL)

May 1, 2000

Study Registration Dates

First Submitted

February 21, 2008

First Submitted That Met QC Criteria

February 29, 2008

First Posted (ESTIMATE)

March 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 29, 2008

Last Update Submitted That Met QC Criteria

May 28, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRU-USA-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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