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

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ClinicalTrials.gov Identifier: NCT00987844
Recruitment Status : Completed
First Posted : October 1, 2009
Last Update Posted : October 1, 2009
Sponsor:
Information provided by:
Movetis

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Constipation Drug: Prucalopride Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1775 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 1998
Actual Primary Completion Date : November 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources


Intervention Details:
    Drug: Prucalopride
    1 mg tablets, free dosing regiment with max. of 4 tablets o.d., treatment duration: up to 24 months


Primary Outcome Measures :
  1. Safety: adverse events, lab tests, vital signs, ECGs [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Efficacy: PAC-QOL self-administered questionnaire, Patient's pattern of use of prucalopride [ Time Frame: 24 months ]
  2. Pharmacokinetics: Prucalopride plasmaconcentrations [ Time Frame: 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987844


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

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
First Posted: October 1, 2009    Key Record Dates
Last Update Posted: October 1, 2009
Last Verified: September 2009

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