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

Phase 2

Completed

• Conditions: Neuropathic Pain
• Interventions: Drug: AZD2423; Drug: Placebo

• Registration Number: NCT01201317
• Lead Sponsor: AstraZeneca

Brief Summary

A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with painful diabetic polyneuropathy.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-13
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-14
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2013-07-25
• Results First Submitted QC: 2013-07-25
• Results First Posted: 2013-09-25
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD2423, 150 mg	AZD2423	Tablets, 150 mg once daily in the morning.
AZD2423, 20 mg	AZD2423	Tablets, 20 mg once daily in the morning.
Placebo	Placebo	Tablets, placebo, once daily in the morning.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.	Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score.	Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28	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.
Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.	Baseline (mean of Day -5 to Day -1) to 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)
Number of Participants With at Least 50% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.	Baseline (mean of Day -5 to Day -1) to 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)
Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scale (NPSI) Total Score.	Baseline (Day 1) to Day 29 (Visit 7)	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.

Trial Locations

Locations (1)

Research Site; 🇨🇦 Laval, Canada