A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..

Study Overview
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Brief Summary
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A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with posttraumatic neuralgia.

Official Title
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A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..

Conditions
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Nerve Pain

Intervention / Treatment
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* Drug: AZD2423
* Drug: AZD2423
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD2423, 20mg<br> | Drug: AZD2423<br>* 20 mg tablet<br>|
| Experimental: AZD2423, 150 mg<br> | Drug: AZD2423<br>* 50 mg tablet<br>|
| Placebo Comparator: Placebo<br>Tablet to match the 20 mg and 50 mg AZD2423 active tablet | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score. | Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) scale 0-10. 0= No pain, 10= Worst pain imaginable. | Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score | Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Worst Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10; 0=No pain, 10=Worst pain imaginable. | Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28 | 
| Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. | LOCF- Last Observation Carried Forward. Numerical Rating Scale (NRS) Average Pain score reduction= (change from baseline at Day 28/baseline)*100. Responder=NRS Average Pain score reduction ≥30% (yes/no) | Baseline (mean of Day -5 to Day -1) to Day 28 | 
| Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (NRS) Average Pain Score at Day 28. | Last Observation Carried Forward (LOCF). Numerical Rating Scale (NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100. Responder= NRS Average Pain score reduction ≥50% (yes/no) | Baseline (mean of Day -5 to Day -1) to Day 28 | 
| Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score. | LOCF- Last Observation Carried Forward. At baseline and at end of treatment the participants filled in their Neuropathic Pain Symptom Inventory Scal (NPSI) pain symptom descriptors, recall period 24 hours. Each descriptor was rated on a NUmerical Rating Scale 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Higher total score is considered worse outcome. | Baseline (Day 1) to Day 29 (Visit 7) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesic effect