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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-19

Study Completion Date

2012-08-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-cancer Pain Opioid Induced Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Resolor

prucalopride

Group Type ACTIVE_COMPARATOR

prucalopride

Intervention Type DRUG

1 or 2 mg prucalopride once daily before breakfast

Interventions

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placebo

Intervention Type DRUG

prucalopride

1 or 2 mg prucalopride once daily before breakfast

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or non-pregnant, non-breast-feeding female outpatient ≥18 years.
2. 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.
3. Subject is suffering from OIC (i.e. secondary to chronic opioid use).
4. Subject agrees to stop his/her laxative treatment and is willing to use rescue medication.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No