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

Shire

Status and phase

Terminated

Phase 3

Conditions

Non-cancer Pain

Opioid Induced Constipation

Treatments

Drug: placebo

Drug: prucalopride

Study type

Interventional

Funder types

Industry

Identifiers

NCT01117051

2009-015652-20 (EudraCT Number)

M0001-C301

SPD555-301 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

174 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria to be assessed at screening:

Male or non-pregnant, non-breast-feeding female outpatient ≥18 years.
Has chronic pain of any aetiology (except cancer pain) requiring daily maintenance treatment with opioids;has been on stable daily opioid dose during at least the previous 2 weeks; and is expected to remain on stable daily dose of opioids for at least 15 weeks after Visit 1.
Subject is suffering from OIC (i.e. secondary to chronic opioid use).
Subject agrees to stop his/her laxative treatment and is willing to use rescue medication.

Main exclusion criteria to be assessed at screening:

Constipation is thought to be drug-induced (except for opioids)
Disallowed medication is being used
Subject was on chronic therapy for chronic constipation prior to start of opioid therapy
Subject is suffering from secondary causes of chronic constipation.