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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01200524
• Date of registration: 10/09/2010
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..
• Scientific title: A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..
• Date of first enrolment: October 2010
• Target sample size: 133
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01200524
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Bulgaria, Denmark, France, Poland, Russian Federation, Sweden, United Kingdom

Contacts

• Name: Bror Jonzon
• Affiliation: AstraZeneca

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Nerve Pain

Intervention(s)

Drug: Placebo

Drug: AZD2423

Primary Outcome(s)

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

Secondary Outcome(s)

Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. [Time Frame: 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. [Time Frame: 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. [Time Frame: Baseline (Day 1) to Day 29 (Visit 7)]

Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score [Time Frame: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28]

Secondary ID(s)

D2600C00012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 25/09/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01200524