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Study to Evaluate Long-Term Safety, Tolerability, and Satisfaction With Prucalopride in Chronic Constipation

This study has been completed.
Sponsor:
Information provided by:
Movetis
ClinicalTrials.gov Identifier:
NCT00987844
First received: September 24, 2009
Last updated: September 30, 2009
Last verified: September 2009
History of Changes
  Purpose

Objectives: To evaluate the clinical long-term safety and the tolerability, patient satisfaction, pharmacokinetics and use of pattern of prucalopride given in doses up to 4 mg per day to patients with chronic constipation (CC).


Condition Intervention Phase
Chronic Constipation
 Drug: Prucalopride
 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Long-Term Tolerability, Safety, Patient Satisfaction, Pharmacokinetics, and Use Patterns of Oral Prucalopride Tablets in Patients With Chronic Constipation

Resource links provided by NLM:

MedlinePlus related topics: Constipation
U.S. FDA Resources

Further study details as provided by Movetis:

Primary Outcome Measures:
  • Safety: adverse events, lab tests, vital signs, ECGs [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: PAC-QOL self-administered questionnaire, Patient's pattern of use of prucalopride [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Prucalopride plasmaconcentrations [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 1775
Study Start Date: July 1998
Primary Completion Date: November 2000 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Prucalopride
    1 mg tablets, free dosing regiment with max. of 4 tablets o.d., treatment duration: up to 24 months
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and non-pregnant, non breast-feeding female outpatients at least 18 years of age.
  2. Patient completed the entire treatment period of one of the following studies: PRU-USA-3, PRU-USA-11, PRU-USA-13, PRU-USA-21, PRU-USA-25, PRU-USA-27 or PRU-USA-28, or Patient participated in the re-treatment study PRU-USA-28 and did not qualify for Treatment period II after both washout periods.

Exclusion Criteria:

  1. Patient with impaired renal function
  2. Patient with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
  3. Female of childbearing potential without adequate contraceptive protection during the study.
  4. Patient who used an investigation drug other than prucalopride in the 30 days preceding the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987844

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Movetis
Investigators
Principal Investigator: Michael Camilleri, MD Mayo Clinic
  More Information

No publications provided by Movetis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Renate Specht Gryp, Movetis
ClinicalTrials.gov Identifier: NCT00987844     History of Changes
Other Study ID Numbers: PRU-USA-22
Study First Received: September 24, 2009
Last Updated: September 30, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013