A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..

April 8, 2014 updated by: AstraZeneca
A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with posttraumatic neuralgia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
  • Denmark
      • Aalborg, Denmark
        • Research Site
      • Odense, Denmark
        • Research Site
  • France
      • Boulogne Billancourt, France
        • Research Site
      • Clermont Ferrand, France
        • Research Site
      • Nice, France
        • Research Site
      • Saint-priest En Jarez, France
        • Research Site
  • Poland
      • Gdansk, Poland
        • Research Site
      • Katowice, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
      • Tychy, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
  • Russian Federation
      • Kazan, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
      • UFA, Russian Federation
        • Research Site
  • Sweden
      • Falköping, Sweden
        • Research Site
      • Kristianstad, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom
        • Research Site
      • Bradford, United Kingdom
        • Research Site
      • Glasgow, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of signed informed consent form
  • Males and female patients aged 18 to 80 years
  • Patients with neuropathic pain due to peripheral nerve injury caused by trauma or surgery

Exclusion Criteria:

  • Other paint that may confound assessment of neuropathic pain
  • History of treatment failure with more than three adequate trials of treatment for neuropathic pain
  • Central neuropathic pain conditions (caused by Central Nervous System injury/disease, eg. Stroke)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AZD2423, 20mg
Drug: AZD2423
20 mg tablet
Drug: AZD2423
50 mg tablet
EXPERIMENTAL: AZD2423, 150 mg
Drug: AZD2423
20 mg tablet
Drug: AZD2423
50 mg tablet
PLACEBO_COMPARATOR: Placebo
Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.
Time Frame: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28
Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) scale 0-10. 0= No pain, 10= Worst pain imaginable.
Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score
Time Frame: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28
Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Worst Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10; 0=No pain, 10=Worst pain imaginable.
Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28
Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.
Time Frame: Baseline (mean of Day -5 to Day -1) to Day 28
LOCF- Last Observation Carried Forward. Numerical Rating Scale (NRS) Average Pain score reduction= (change from baseline at Day 28/baseline)*100. Responder=NRS Average Pain score reduction ≥30% (yes/no)
Baseline (mean of Day -5 to Day -1) to Day 28
Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (NRS) Average Pain Score at Day 28.
Time Frame: Baseline (mean of Day -5 to Day -1) to Day 28

Last Observation Carried Forward (LOCF). Numerical Rating Scale (NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100.

Responder= NRS Average Pain score reduction ≥50% (yes/no)
Baseline (mean of Day -5 to Day -1) to Day 28
Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score.
Time Frame: Baseline (Day 1) to Day 29 (Visit 7)
LOCF- Last Observation Carried Forward. At baseline and at end of treatment the participants filled in their Neuropathic Pain Symptom Inventory Scal (NPSI) pain symptom descriptors, recall period 24 hours. Each descriptor was rated on a NUmerical Rating Scale 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Higher total score is considered worse outcome.
Baseline (Day 1) to Day 29 (Visit 7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Bror Jonzon, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

September 10, 2010

First Submitted That Met QC Criteria

September 10, 2010

First Posted (ESTIMATE)

September 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 25, 2014

Last Update Submitted That Met QC Criteria

April 8, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2600C00012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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