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

NCT00627692 | Completed Phase 2

• 1 other identifier: PRU-USA-26
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Constipation

Keywords

Constipation in elderly patients

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (1)

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

  4 weeks

Study Arms (5)

1

ACTIVE COMPARATOR

Prucalopride

Drug: Prucalopride

2

ACTIVE COMPARATOR

Prucalopride

Drug: Prucalopride

3

ACTIVE COMPARATOR

Prucalopride

Drug: Prucalopride

5

PLACEBO COMPARATOR

Placebo

Other: Placebo

4

ACTIVE COMPARATOR

Prucalopride

Drug: Prucalopride

Interventions

Prucalopride DRUG

0.5 mg o.d.

Also known as: Resolor

1

Placebo OTHER

o.d.

5

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Movetis: lead

Related Publications (1)

• 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.

  PMID: 19751247 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

prucalopride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• D O'Neill, MD

  Riverside Regional Convalescent Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 21, 2008
• First Posted: March 3, 2008
• Study Start: February 1, 1999
• Primary Completion: May 1, 2000
• Study Completion: May 1, 2000
• Last Updated: May 29, 2008

Record last verified: 2008-01