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

Primary Purpose

Neuropathic Pain

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD2423
AZD2423
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Analgesic effect

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Research Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

AZD2423, 150 mg

AZD2423, 20 mg

Placebo

Arm Description

Tablets, 150 mg once daily in the morning.

Tablets, 20 mg once daily in the morning.

Tablets, placebo, once daily in the morning.

Outcomes

Primary Outcome Measures

Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.
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.

Secondary Outcome Measures

Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score.
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.
Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at 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)
Number of Participants With at Least 50% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at 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)
Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scale (NPSI) Total Score.
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.

Full Information

First Posted
September 13, 2010
Last Updated
April 8, 2014
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01201317
Brief Title
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy
Official Title
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Analgesic effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZD2423, 150 mg
Arm Type
Experimental
Arm Description
Tablets, 150 mg once daily in the morning.
Arm Title
AZD2423, 20 mg
Arm Type
Experimental
Arm Description
Tablets, 20 mg once daily in the morning.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Tablets, placebo, once daily in the morning.
Intervention Type
Drug
Intervention Name(s)
AZD2423
Intervention Description
20 mg tablet
Intervention Type
Drug
Intervention Name(s)
AZD2423
Intervention Description
150 mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.
Description
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.
Time Frame
Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28
Secondary Outcome Measure Information:
Title
Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score.
Description
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.
Time Frame
Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28
Title
Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.
Description
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)
Time Frame
Baseline (mean of Day -5 to Day -1) to Day 28
Title
Number of Participants With at Least 50% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.
Description
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)
Time Frame
Baseline (mean of Day -5 to Day -1) to Day 28
Title
Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scale (NPSI) Total Score.
Description
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.
Time Frame
Baseline (Day 1) to Day 29 (Visit 7)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bror Jonzon
Organizational Affiliation
AstraZeneca R&D Södertälje
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Goodyear
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Deland
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Sunrise
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Madisonville
State/Province
Kentucky
Country
United States
Facility Name
Research Site
City
Willingboro
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Winston-salem
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Research Site
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Etobicoke
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Lachine
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Laval
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=204&filename=CSR-D2600C00005.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=204&filename=CSR-D2600C00005.pdf
Description
CSR-D2600C00005.pdf

Learn more about this trial

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

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