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Completed

NCT Number: NCT00987844

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

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).

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Key information

Conditions

Chronic Constipation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

prucalopride

Drug

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

Primary outcomes

  1. Safety: adverse events, lab tests, vital signs, ECGs

    Time frame: 24 months

Secondary outcomes

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

    Time frame: 24 months

  2. Pharmacokinetics: Prucalopride plasmaconcentrations

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Movetis

Industry

Registry information

Official study 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

Important dates

Study start
1998
Primary completion
2000
First posted
Oct 1, 2009
Registry last updated
Oct 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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