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NCT01070615 Clinical Trial

Study to Evaluate Long-Term Tolerability and Safety of Oral Prucalopride in Chronic Constipation

Chronic Constipation Clinical Trial

Official title:
A Study to Evaluate the Long-Term Tolerability and Safety of Oral Prucalopride Administered to Patients With Chronic Constipation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01070615
Other study ID # PRU-INT-10
Secondary ID
Status Completed
Phase Phase 3
First received February 17, 2010
Last updated March 1, 2010
Start date June 1998

Study information
Verified date February 2010
Source Movetis
Contact n/a
Is FDA regulated No
Health authority European Union: European Medicines Agency
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 693
Est. completion date
Est. primary completion date November 2000
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Prucalopride

Locations
Country Name City State
Belgium University Hospital Antwerp Edegem

Sponsors (1)
Lead Sponsor Collaborator
Movetis

Country where clinical trial is conducted

Belgium, 

See also
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