NCT01070615

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
693

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2000

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2010

Completed
Last Updated

March 2, 2010

Status Verified

February 1, 2010

Enrollment Period

2.4 years

First QC Date

February 17, 2010

Last Update Submit

March 1, 2010

Conditions

Chronic Constipation

Interventions

PrucaloprideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Antwerp

Edegem, 2650, Belgium

Location

Related Publications (1)

  • Camilleri M, Van Outryve MJ, Beyens G, Kerstens R, Robinson P, Vandeplassche L. Clinical trial: the efficacy of open-label prucalopride treatment in patients with chronic constipation - follow-up of patients from the pivotal studies. Aliment Pharmacol Ther. 2010 Nov;32(9):1113-23. doi: 10.1111/j.1365-2036.2010.04455.x. Epub 2010 Sep 16.

    PMID: 21039673DERIVED

MeSH Terms

Interventions

prucalopride

Study Officials

  • Marc Van Outryve, MD

    University Hospital Antwerp, Edegem, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 17, 2010

First Posted

February 18, 2010

Study Start

June 1, 1998

Primary Completion

November 1, 2000

Last Updated

March 2, 2010

Record last verified: 2010-02

Locations

BE(1)