Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-09-30

Brief Summary

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The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

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Detailed Description

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Patients with a documented history of moderate to severe non-malignant pain that require around-the-clock opioid therapy will be randomised to an oxycodone or an oxycodone-naloxone treatment arm. The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Oxycodone naloxone prolonged release tablets (OXN)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects at least 18 years or older with moderate to severe pain that requires around the clock opioid therapy. Subjects must report constipation caused or aggravated by opioids.

Exclusion Criteria

* Females who are pregnant or lactating.
* Subjects with evidence of any clinically unstable disease or subjects with evidence of impaired liver/kidney function upon entry into the study.
* Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No