A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy

April 8, 2014 updated by: AstraZeneca

A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo

A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with painful diabetic polyneuropathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

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

  • Canada
      • Laval, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • Ontario
      • Brampton, Ontario, Canada
        • Research Site
      • Etobicoke, Ontario, Canada
        • Research Site
      • Mississauga, Ontario, Canada
        • Research Site
    • Quebec
      • Lachine, Quebec, Canada
        • Research Site
  • United States
    • Arizona
      • Goodyear, Arizona, United States
        • Research Site
      • Phoenix, Arizona, United States
        • Research Site
      • Tucson, Arizona, United States
        • Research Site
    • California
      • Los Angeles, California, United States
        • Research Site
    • Florida
      • Deland, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • Sunrise, Florida, United States
        • Research Site
    • Kentucky
      • Madisonville, Kentucky, United States
        • Research Site
    • New Jersey
      • Willingboro, New Jersey, United States
        • Research Site
    • New York
      • New York, New York, United States
        • Research Site
    • North Carolina
      • Winston-salem, North Carolina, United States
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Research Site
    • Texas
      • Houston, Texas, United States
        • 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 of non-child bearing potential patients aged 18 to 80 years
  • Patients with neuropathic pain due to painful diabetic polyneuropathy.

Exclusion Criteria:

  • Other pain that may confound assessment of neuropathic pain
  • History of treatment failure with more than three adequate trials of medication 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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AZD2423, 150 mg
Tablets, 150 mg once daily in the morning.
Drug: AZD2423
20 mg tablet
Drug: AZD2423
150 mg tablet
Experimental: AZD2423, 20 mg
Tablets, 20 mg once daily in the morning.
Drug: AZD2423
20 mg tablet
Drug: AZD2423
150 mg tablet
Placebo Comparator: Placebo
Tablets, placebo, once daily in the morning.
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) 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

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 ≥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 Rating Scale (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 Scale (NPSI) Total Score.
Time Frame: Baseline (Day 1) to Day 29 (Visit 7)
Last Observation carried Forward (LOCF). Scale consists of 10 Neuropathic Pain Symptom Inventory Scale (NPSI) pain symptom descriptors wiht a recall period of 24 hours. Each descriptor is rated on a Numerical Rating Scale (NRS) 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Range for total score 0 -100. Higher total score implicates worse symptoms.
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 R&D Södertälje

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

September 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

September 13, 2010

First Submitted That Met QC Criteria

September 13, 2010

First Posted (Estimate)

September 14, 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

  • D2600C00005

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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