A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy

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 painful diabetic polyneuropathy.

Official Title
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A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo

Conditions
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Neuropathic 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 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)

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, 150 mg<br>Tablets, 150 mg once daily in the morning. | Drug: AZD2423<br>* 150 mg tablet<br>|
| Experimental: AZD2423, 20 mg<br>Tablets, 20 mg once daily in the morning. | Drug: AZD2423<br>* 20 mg tablet<br>|
| Placebo Comparator: Placebo<br>Tablets, placebo, once daily in the morning. | 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) 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. | 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 ≥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 Rating Scale (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 Scale (NPSI) Total Score. | Last Observation carried Forward (LOCF). Scale consists of 10 Neuropathic Pain Symptom Inventory Scale (NPSI) pain symptom descriptors wiht a recall period of 24 hours. Each descriptor is rated on a Numerical Rating Scale (NRS) 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Range for total score 0 -100. Higher total score implicates worse symptoms. | 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