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Study to Evaluate Long-Term Tolerability and Safety of Oral 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.
ClinicalTrials.gov Identifier: NCT01070615
Recruitment Status : Completed
First Posted : February 18, 2010
Last Update Posted : March 2, 2010
Information provided by:

Study Description
Brief Summary:
Objectives: Evaluation of the clinical long-term safety, tolerability, patient satisfaction, pharmacokinetics and pattern of use of oral prucalopride tablets given in doses up to 4 mg once daily to patients with chronic constipation

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 693 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Long-Term Tolerability and Safety of Oral Prucalopride Administered to Patients With Chronic Constipation
Study Start Date : June 1998
Primary Completion Date : November 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or non-pregnant, non-breast-feeding female outpatients of at least 18 years of age
  2. Patient had completed the entire treatment period of the PRU-INT-6 study or the PRU-INT-12 study .

Exclusion Criteria:

  1. Patients with impaired renal function
  2. Patients with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
  3. Females of child-bearing potential without adequate contraceptive protection during the study.
Contacts and Locations

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): NCT01070615

University Hospital Antwerp
Edegem, Belgium, 2650
Sponsors and Collaborators
Principal Investigator: Marc Van Outryve, MD University Hospital Antwerp, Edegem, Belgium
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Renate Specht Gryp, Movetis
ClinicalTrials.gov Identifier: NCT01070615     History of Changes
Other Study ID Numbers: PRU-INT-10
First Posted: February 18, 2010    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: February 2010

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