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
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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