NCT00987844

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).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
1,775

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

July 1, 1998

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2000

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 1, 2009

Completed
Last Updated

October 1, 2009

Status Verified

September 1, 2009

Enrollment Period

2.3 years

First QC Date

September 24, 2009

Last Update Submit

September 30, 2009

Conditions

Chronic Constipation

Outcome Measures

Primary Outcomes (1)

  • Safety: adverse events, lab tests, vital signs, ECGs

    24 months

Secondary Outcomes (2)

  • Efficacy: PAC-QOL self-administered questionnaire, Patient's pattern of use of prucalopride

    24 months

  • Pharmacokinetics: Prucalopride plasmaconcentrations

    24 months

Interventions

PrucaloprideDRUG

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

Eligibility Criteria

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

You may qualify if:

  • Male and non-pregnant, non breast-feeding female outpatients at least 18 years of age.
  • 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.

You may not qualify if:

  • Patient with impaired renal function
  • Patient with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
  • Female of childbearing potential without adequate contraceptive protection during the study.
  • Patient who used an investigation drug other than prucalopride in the 30 days preceding the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

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

  • Michael Camilleri, MD

    Mayo Clinic

    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

September 24, 2009

First Posted

October 1, 2009

Study Start

July 1, 1998

Primary Completion

November 1, 2000

Last Updated

October 1, 2009

Record last verified: 2009-09

Locations

US(1)