Study to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Peripheral Neuropathic Pain (AVANT)

AstraZeneca

Status and phase: Terminated; Phase 2

Conditions: Neuropathic Pain; Pain

Treatments: Drug: AZD1386; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00976534

D5090C00018

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD1386

2

Placebo Comparator group

Treatment:

Drug: Placebo