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To Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Between OXN PR Higher Dose & Lower Dose Tablet Strengths in Subjects With Non-cancer or Cancer Pain

NCT ID: NCT02321397

Last Updated: 2016-11-04

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

PHASE2/PHASE3

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-09-30

Brief Summary

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This study is aimed to demonstrate equivalence between combinations of lower strength OXN PR tablets (OXN PR LST) and single higher strength OXN PR tablets (OXN PR HST) taken at the same overall daily dose.

Detailed Description

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Study OXN3508 is a multicenter double-blind, double-dummy, randomised, cross-over, 2-period, phase III study in male and female subjects with severe non-malignant or malignant pain that requires around-the-clock opioid therapy at a daily dose of 120/60 mg or 160/80 mg oxycodone/naloxone prolonged release (OXN PR).

Conditions

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Malignant Pain Non-malignant Pain

Keywords

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oxycodone naloxone combination severe chronic and non-malignant pain Malignant and non-malignant pain that requires around-the clock opioid therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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OXN PR HST

Prolonged release oxycodone/naloxone higher strength tablets

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

OXN PR LST

Prolonged release oxycodone/naloxone lower strength tablets

Group Type ACTIVE_COMPARATOR

Naloxone

Intervention Type DRUG

Prolonged Release Tablets

Interventions

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Oxycodone

Intervention Type DRUG

Naloxone

Prolonged Release Tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects who are receiving WHO step III opioid analgesic medication for the treatment of non-malignant or malignant pain.
* Documented history of non-malignant or malignant pain that requires around-the-clock opioid therapy

Exclusion Criteria

* Females who are pregnant or lactating.
* Subjects with evidence or significant structural abnormalities of the gastrointestinal tract.
* Subjects with evidence of impaired liver/kidney function upon entry into the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mundipharma Research GmbH & Co KG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mainz, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2013-004888-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

OXN3508

Identifier Type: -

Identifier Source: org_study_id