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Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation

NCT01117051 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2021-06-11

Study results available
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Summary

The study will evaluate the efficacy, safety and tolerability of prucalopride over 12 weeks of treatment in subjects aged 18 years and older with chronic non-cancer pain, suffering from opioid induced constipation.

Conditions

  • Non-cancer Pain
  • Opioid Induced Constipation

Interventions

DRUG

placebo

placebo

DRUG

prucalopride

1 or 2 mg prucalopride once daily before breakfast

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
2010-05-19
Primary Completion
2012-08-13
Completion
2012-08-13

Countries

  • Belgium

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 NCT01117051 on ClinicalTrials.gov