Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00987844
Recruitment Status : Completed
First Posted : October 1, 2009
Last Update Posted : October 1, 2009
Information provided by:

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

Layout table for study information
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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00987844

Layout table for location information
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Layout table for investigator information
Principal Investigator: Michael Camilleri, MD Mayo Clinic

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Renate Specht Gryp, Movetis 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:
Layout table for MeSH terms
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Agents
Serotonin 5-HT4 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs