Phase 2
N=133
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..
Nerve Pain
Bottom Line
View on ClinicalTrials.gov: NCT01200524 ↗Enrolled (actual)
133
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score. — -1.53; -1.54; -1.44 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD2423 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score. |
-1.53; -1.54; -1.44 | — |
| SECONDARY Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score |
-1.8; -1.29; -1.4 | — |
| SECONDARY Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. |
17; 15; 17 | — |
| SECONDARY Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (NRS) Average Pain Score at Day 28. |
9; 8; 9 | — |
| SECONDARY Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score. |
-16.58; -8.82; -9.8 | — |
Summary
A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with posttraumatic neuralgia.
Eligibility Criteria
Inclusion Criteria
- Provision of signed informed consent form
- Males and female patients aged 18 to 80 years
- Patients with neuropathic pain due to peripheral nerve injury caused by trauma or surgery
Exclusion Criteria
- Other paint that may confound assessment of neuropathic pain
- History of treatment failure with more than three adequate trials of treatment for neuropathic pain
- Central neuropathic pain conditions (caused by Central Nervous System injury/disease, eg. Stroke)
Data sourced from ClinicalTrials.gov (NCT01200524). 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.