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

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)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00976534

Acronym

AVANT

Enrollment

Registered

2009-09-14

Start date

2009-09-30

Completion date

2010-02-28

Last updated

2009-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic Pain, Pain

Keywords

Analgesic effect, Peripheral Neuropathic pain, Posttraumatic Neuralgia (PTN), Postherpetic Neuralgia (PHN)

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.

Interventions

DRUGAZD1386

90 mg, capsules, oral, during 3 weeks

DRUGPlacebo

capsules, oral, during 3 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in NRS pain (12 h-recall)	Morning and evening 12 hour recall

Secondary

Measure	Time frame
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	Morning and evening 12 hour recall
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	Day 8, 15 and 22
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	Day 1 and 22

Countries

Canada, Denmark, France, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026