Phase 2
Completed N=127
Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy
Source: ClinicalTrials.gov NCT00857623 ↗Enrolled (actual)
127
Serious AEs
1.6%
Results posted
Oct 2012
Primary outcomePrimary: Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment — -2.33; -2.52 Scores on a scale
Summary
The purpose of this study is to investigate if AZD2066 can relieve the pain arising from painful diabetic neuropathy compared to placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment |
-2.33; -2.52 | — |
| SECONDARY Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28. |
-2.3; -2.5 | — |
| SECONDARY Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28 |
23; 25 | — |
| SECONDARY Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28 |
15; 15 | — |
| SECONDARY Number of Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" at Day 28. |
20; 28 | — |
| SECONDARY Change in McGill Pain Questionnaire Short Form (MPQ-SF) Sensory Index From Baseline to Day 28. |
-6.87; -7.68 | — |
| SECONDARY Change in McGill Pain Questionnaire Short Form (MPQ-SF) Affective Index From Baseline to Day 28. |
-1.87; -2.06 | — |
| SECONDARY Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28. |
-1.99; -2.19 | — |
| SECONDARY Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Interference From Baseline to Day 28. |
-2.13; -2.13 | — |
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent prior to any study specific procedures.
- Clinical diagnosis of painful diabetic neuropathy.
- non-fertile females
Exclusion Criteria
- Other pain that may confound assessment of neuropathic pain.
- Ongoing significant peripheral arterial diseases, skin ulcers, or amputation in the lower extremities.
- History of psychotic disorders among first degree relatives.
Data sourced from ClinicalTrials.gov (NCT00857623). 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.