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Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged ≥ 18 Years

NCT01424228 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2021-06-11

Study results available
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Summary

The purpose of this trial is to evaluate the long-term (24 weeks) efficacy of prucalopride versus placebo in subjects aged 18 years and older with chronic constipation.

Conditions

Interventions

DRUG

placebo

Placebo matching tablet 2 mg once daily before breakfast for 24 weeks

DRUG

prucalopride

Prucalopride 2 mg daily before breakfast 1 mg for subjects \>65 years; in case of insufficient response 2 mg at week 2 or week 4

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-06
Primary Completion
2012-12-19
Completion
2012-12-19

Countries

  • Belgium
  • Czechia
  • Hungary
  • Italy
  • Poland
  • Romania
  • Slovakia
  • Spain
  • Sweden

Study Locations

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Entities

Drugs
Diseases

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 NCT01424228 on ClinicalTrials.gov