Clinical trial NCT00976534: Study to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Peripheral Neuropathic Pain
Official title: A Phase IIa Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 After 3 Weeks of Treatment in Patients With Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain
Neuropathic Pain
Keywords: Analgesic effect
Peripheral Neuropathic pain
Posttraumatic Neuralgia (PTN)
Postherpetic Neuralgia (PHN)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-09-14
Enrollment: 90
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: The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with peripheral neuropathic pain. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain.


Eligibility criteria: Inclusion Criteria:

* Patients with painful symptoms due to neuropathic pain
* Provision of signed informed consent
* Non pregnant females

Exclusion Criteria:

* Other pain conditions that may confound assessment of neuropathic pain, as judged by the investigator
* History, and/or presence of somatic disease, which may interfere with the objectives of the study as judged by the investigator

Primary outcomes:
measure: Change from baseline in NRS pain (12 h-recall)
timeFrame: Morning and evening 12 hour recall
Secondary outcomes:
measure: Response rate, defined as any of the following:NRS (12 h recall) reduced by 30% compared to baseline and NRS (12 h recall) reduced by 50% compared to baseline
timeFrame: Morning and evening 12 hour recall
measure: Response rate, defined as any of the following: At least "much improved" on Patient Global Impression of Change global and at least "much improved" on PGIC pain
timeFrame: Day 8, 15 and 22
measure: Response rate, defined as any of the following: Change from baseline in Brief Pain Inventory Short Form and Change from baseline in Pain Quality Assessment Scale
timeFrame: Day 1 and 22
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Alborg
country: Denmark
facility: Research Site
city: Arhus C
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: Bradford
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Wilmington, USA
name: Richard L Leff, md
role: STUDY_DIRECTOR
affiliation: AstraZeneca R&D Södertälje, Sweden
name: Rolf Karlsten, MD
role: STUDY_CHAIR
References: