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

Mundipharma

Status and phase: Completed; Phase 2

Conditions: Moderate to Severe Pain Due to Diabetic Polyneuropathy

Treatments: Drug: Placebo tablets; Drug: Oxycodone Naloxone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00944697

2008-005815-17

OXN2502

Details and patient eligibility

About

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

Full description

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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 2 patient groups, including a placebo group

Tablets

Placebo Comparator group

Description:

A placebo tablet to match the active reference treatment

Treatment:

Drug: Placebo tablets

Tablet

Active Comparator group

Description:

Oxycodone Naloxone tablets

Treatment:

Drug: Oxycodone Naloxone