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

Phase 2

Completed

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

• Registration Number: NCT01200524
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-10
• Study First Submitted QC: 2010-09-10
• Study First Posted: 2010-09-13
• Study Start: 2010-10
• Primary Completion: 2012-04
• Study Completion: 2012-04
• 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: 133

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD2423, 20mg	AZD2423	-
AZD2423, 150 mg	AZD2423	-
Placebo	Placebo	Tablet to match the 20 mg and 50 mg AZD2423 active tablet

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) scale 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	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)
Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (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 Scal (NPSI) Total Score.	Baseline (Day 1) to Day 29 (Visit 7)	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.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Manchester, United Kingdom