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OpenTrials
Completed

NCT Number: NCT01070615

Study to Evaluate Long-Term Tolerability and Safety of Oral Prucalopride in Chronic Constipation

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

Completed

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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

University Hospital Antwerp

Edegem, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 .

Exclusion criteria

  • 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.

Treatment and study plan

prucalopride

Drug

Sponsors and collaborators

Lead sponsor

Movetis

Industry

Registry information

Official study title

A Study to Evaluate the Long-Term Tolerability and Safety of Oral Prucalopride Administered to Patients With Chronic Constipation

Important dates

Study start
1998
Primary completion
2000
First posted
Feb 18, 2010
Registry last updated
Mar 2, 2010

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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