Phase 2
Completed N=98
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
Moderate to Severe Pain Due to Diabetic Polyneuropathy
Source: ClinicalTrials.gov NCT00944697 ↗
Enrolled (actual)
98
Serious AEs
4.1%
Results posted
Feb 2012
Primary outcomePrimary: Short Form McGill Pain Score. — 49.56; 47.65 units on a scale
Summary
To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short Form McGill Pain Score. |
49.56; 47.65 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00944697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.