Clinical trial NCT01200524: A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..
Official title: A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nerve Pain
Keywords: Analgesic effect
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-13
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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)

Primary outcomes:
measure: Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.
timeFrame: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28
Secondary outcomes:
measure: Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score
timeFrame: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28
measure: Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.
timeFrame: Baseline (mean of Day -5 to Day -1) to Day 28
measure: Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (NRS) Average Pain Score at Day 28.
timeFrame: Baseline (mean of Day -5 to Day -1) to Day 28
measure: Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score.
timeFrame: Baseline (Day 1) to Day 29 (Visit 7)
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Aalborg
country: Denmark
facility: Research Site
city: Odense
country: Denmark
facility: Research Site
city: Boulogne Billancourt
country: France
facility: Research Site
city: Clermont Ferrand
country: France
facility: Research Site
city: Nice
country: France
facility: Research Site
city: Saint-priest En Jarez
country: France
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Tychy
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: UFA
country: Russian Federation
facility: Research Site
city: Falköping
country: Sweden
facility: Research Site
city: Kristianstad
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Bradford
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Bror Jonzon
role: STUDY_DIRECTOR
References: