Clinical trial NCT01201317: A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy
Official title: A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuropathic Pain
Keywords: Analgesic effect
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-14
Enrollment: 134
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 painful diabetic polyneuropathy.


Eligibility criteria: 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)

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 Rating Scale (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 Scale (NPSI) Total Score.
timeFrame: Baseline (Day 1) to Day 29 (Visit 7)
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Deland
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Sunrise
country: United States
facility: Research Site
state: Florida
city: Madisonville
country: United States
facility: Research Site
state: Kentucky
city: Willingboro
country: United States
facility: Research Site
state: New Jersey
city: New York
country: United States
facility: Research Site
state: New York
city: Winston-salem
country: United States
facility: Research Site
state: North Carolina
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Houston
country: United States
facility: Research Site
state: Texas
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Brampton
country: Canada
facility: Research Site
state: Ontario
city: Etobicoke
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Lachine
country: Canada
facility: Research Site
state: Quebec
city: Laval
country: Canada
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Södertälje
name: Bror Jonzon
role: STUDY_DIRECTOR
References: