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Evaluation of Prucalopride in Male Subjects With Chronic Constipation.

NCT01147926 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2021-06-10

Study results available
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Summary

This is a multi-centre, randomised, parallel-group, double-blind, placebo-controlled phase III trial to evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment in male subjects with chronic constipation.

Furthermore the safety, tolerability, effect on quality of life and effect on symptoms of prucalopride will be assessed.

Conditions

  • Male Subjects With Chronic Constipation

Interventions

DRUG

Placebo

Placebo matched to Prucalopride tablet orally once daily.

DRUG

Prucalopride

Prucalopride 2 mg tablet orally once daily for subjects greater than or equal to (≥) 18 to less than (\<) 65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-23
Primary Completion
2013-10-25
Completion
2013-10-25

Countries

  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • France
  • Germany
  • Netherlands
  • Poland
  • Romania
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT01147926 on ClinicalTrials.gov