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A Study to Demonstrate the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Addition to Pregabalin Compared to Pregabalin Alone in Opioid-naïve Subjects Treated With Pregabalin Suffering From Moderate to Severe Pain Due to Diabetic Polyneuropathy

NCT ID: NCT00944697

Last Updated: 2012-08-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-04-30

Brief Summary

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To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone.

Detailed Description

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Study OXN2502 is a pilot, exploratory, randomised, placebo-controlled, double-blind, single-dummy, parallel group study to assess efficacy and safety of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone in opioid-naïve subjects treated with pregabalin suffering from moderate to severe pain due to diabetic polyneuropathy.

Conditions

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Moderate to Severe Pain Due to Diabetic Polyneuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tablets

A placebo tablet to match the active reference treatment

Group Type PLACEBO_COMPARATOR

Placebo tablets

Intervention Type DRUG

Placebo Oxycodone Naloxone tablets

Tablet

Oxycodone Naloxone tablets

Group Type ACTIVE_COMPARATOR

Oxycodone Naloxone

Intervention Type DRUG

Oxycodone Naloxone tablets

Interventions

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Oxycodone Naloxone

Oxycodone Naloxone tablets

Intervention Type DRUG

Placebo tablets

Placebo Oxycodone Naloxone tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe pain due diabetic polyneuropathy
* Opioid-naive subjects

Exclusion Criteria

* Females who are pregnant or lactating
* Subjects with evidence of 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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Dr Oliver Emrich

Ludwigshafen, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.mundipharma-rd.eu

Results available on website

Other Identifiers

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2008-005815-17

Identifier Type: -

Identifier Source: secondary_id

OXN2502

Identifier Type: -

Identifier Source: org_study_id