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Efficacy and Safety Study of Prucalopride for the Treatment of Chronic Constipation

NCT00483886 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 620

Last updated 2013-04-11

No results posted yet for this study

Summary

The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation.

Hypothesis:

Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the treatment of patients with chronic constipation and is well tolerated in those patients.

Conditions

Interventions

DRUG

Prucalopride

2 mg o.d.

OTHER

Placebo

Placebo o.d.

DRUG

Prucalopride

4 mg o.d.

Sponsors & Collaborators

  • Movetis

    lead INDUSTRY

Principal Investigators

  • Michael Camilleri, M.D. · Mayo Graduate School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-04-30
Primary Completion
1999-05-31
Completion
1999-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00483886 on ClinicalTrials.gov