Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Chronic Idiopathic Constipation

NCT00596596 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2008-05-29

No results posted yet for this study

Summary

The purpose of the study is to determine whether prucalopride is safe and effective in patients with chronic idiopathic constipation.

Hypothesis:

At all doses administered prucalopride given once daily for 4 weeks is safe and well tolerated in patients with chronic idiopathic constipation.

Conditions

Interventions

DRUG

prucalopride

0,5 mg once daily

DRUG

prucalopride

1 mg once daily

DRUG

2 mg prucalopride

2 mg once daily

DRUG

4 mg prucalopride

4 mg once daily

OTHER

Placebo

placebo once daily

Sponsors & Collaborators

  • Movetis

    lead INDUSTRY

Principal Investigators

  • Trent Nichols, MD · Hanover General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-09-30
Primary Completion
1997-06-30
Completion
1997-06-30

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Entities

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 NCT00596596 on ClinicalTrials.gov