Phase 2
Completed N=134
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy
Source: ClinicalTrials.gov NCT01201317 ↗Enrolled (actual)
134
Serious AEs
2.3%
Results posted
Sep 2013
Primary outcomePrimary: Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score. — -1.35; -1.50; -1.61 Scores on a scale
Summary
A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with painful diabetic polyneuropathy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score. |
-1.35; -1.50; -1.61 | — |
| SECONDARY Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score. |
-1.57; -1.66; -1.80 | — |
| SECONDARY Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. |
16; 19; 15 | — |
| SECONDARY Number of Participants With at Least 50% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. |
10; 8; 10 | — |
| SECONDARY Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scale (NPSI) Total Score. |
-14.63; -12.20; -7.82 | — |
Eligibility Criteria
Inclusion Criteria
- Provision of signed informed consent form
- Males and female of non-child bearing potential patients aged 18 to 80 years
- Patients with neuropathic pain due to painful diabetic polyneuropathy.
Exclusion Criteria
- Other pain that may confound assessment of neuropathic pain
- History of treatment failure with more than three adequate trials of medication for neuropathic pain
- Central neuropathic pain conditions (caused by Central Nervous System injury/disease, eg. Stroke)
Data sourced from ClinicalTrials.gov (NCT01201317). 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.