NCT00976534

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2 pain

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_2 pain

Geographic Reach
4 countries

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

December 23, 2009

Status Verified

December 1, 2009

First QC Date

September 9, 2009

Last Update Submit

December 21, 2009

Conditions

PainNeuropathic Pain

Keywords

Analgesic effectPeripheral Neuropathic painPosttraumatic Neuralgia (PTN)Postherpetic Neuralgia (PHN)

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in NRS pain (12 h-recall)

    Morning and evening 12 hour recall

Secondary Outcomes (3)

  • 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

Study Arms (2)

1

EXPERIMENTAL
Drug: AZD1386

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD1386DRUG

90 mg, capsules, oral, during 3 weeks

1
PlaceboDRUG

capsules, oral, during 3 weeks

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Research Site

Calgary, Alberta, Canada

Location

Research Site

Halifax, Nova Scotia, Canada

Location

Research Site

Toronto, Ontario, Canada

Location

Research Site

Aalborg, Denmark

Location

Research Site

Arhus C, Denmark

Location

Research Site

Boulogne-Billancourt, France

Location

Research Site

Clermont-Ferrand, France

Location

Research Site

Nice, France

Location

Research Site

Bradford, United Kingdom

Location

Research Site

Glasgow, United Kingdom

Location

Research Site

London, United Kingdom

Location

Research Site

Manchester, United Kingdom

Location

MeSH Terms

Conditions

PainNeuralgiaNeuralgia, Postherpetic

Interventions

AZD1386

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Richard L Leff, md

    AstraZeneca R&D Wilmington, USA

    STUDY DIRECTOR

  • Rolf Karlsten, MD

    AstraZeneca R&D Södertälje, Sweden

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2009

First Posted

September 14, 2009

Study Start

September 1, 2009

Study Completion

February 1, 2010

Last Updated

December 23, 2009

Record last verified: 2009-12

Locations

FR(3)DK(2)CA(3)GB(4)