Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01070615
NCT01070615CompletedPhase 3

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

Movetis2 sites in 1 country693 target enrollmentStarted: June 1, 1998Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
693
Locations
2
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Investigators

Sponsor
Movetis
Sponsor Class
Industry

Study Sites (2)

Loading locations...

Similar Trials

Completed
Phase 3
Study to Evaluate Long-Term Safety, Tolerability, and Satisfaction With Prucalopride in Chronic ConstipationChronic Constipation
NCT00987844Movetis1,775
Completed
Phase 3
Long-term Study of Cariprazine in Patients With SchizophreniaSchizophrenia
NCT01104792Forest Laboratories752
Completed
Not Applicable
Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular LensCataractPresbyopia
NCT03314766AcuFocus, Inc.64
Completed
Phase 1
Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination RegimenNeoplasm Malignant
NCT01587040Sanofi61
Completed
Phase 3
Long-term Safety and Tolerability of Cariprazine for Bipolar I DisorderBipolar I Disorder
NCT01059539Forest Laboratories403
Study to Evaluate Long-Term Tolerability... | Clinical Trial