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

• Sponsor: Movetis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00987844
• Collaborator: (none)
• Enrollment: 1,775
• Location: 1

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 1775 participants
• Allocation: N/A
• 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: Jul 1, 1998
• Actual Primary Completion Date: Nov 1, 2000

Outcome Measures

Primary Outcome Measures

1. Safety: adverse events, lab tests, vital signs, ECGs [24 months]

Secondary Outcome Measures

1. Efficacy: PAC-QOL self-administered questionnaire, Patient's pattern of use of prucalopride [24 months]

2. Pharmacokinetics: Prucalopride plasmaconcentrations [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Movetis

Investigators

• Principal Investigator: Michael Camilleri, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00987844
• Other Study ID Numbers: PRU-USA-22
• First Posted: Oct 1, 2009
• Last Update Posted: Oct 1, 2009
• Last Verified: Sep 1, 2009

• Additional relevant MeSH terms: Constipation; Prucalopride

Study Results

No Results Posted as of Oct 1, 2009