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

Chronic Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987844
• Other study ID #: PRU-USA-22
• Status: Completed
• Phase: Phase 3
• First received: September 24, 2009
• Last updated: September 30, 2009
• Start date: July 1998

Study information

• Verified date: September 2009
• Source: Movetis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1775
• Est. primary completion date: November 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Movetis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: adverse events, lab tests, vital signs, ECGs		24 months	No
Secondary	Efficacy: PAC-QOL self-administered questionnaire, Patient's pattern of use of prucalopride		24 months	No
Secondary	Pharmacokinetics: Prucalopride plasmaconcentrations		24 months	No