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

Primary Purpose

Nerve 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 Nerve 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 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)

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, 20mg

AZD2423, 150 mg

Placebo

Arm Description

Tablet to match the 20 mg and 50 mg AZD2423 active tablet

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) scale 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.
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)
Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (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 Scal (NPSI) Total Score.
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.

Full Information

First Posted
September 10, 2010
Last Updated
April 8, 2014
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01200524
Brief Title
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..
Official Title
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (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 posttraumatic neuralgia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve 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
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZD2423, 20mg
Arm Type
Experimental
Arm Title
AZD2423, 150 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Intervention Type
Drug
Intervention Name(s)
AZD2423
Intervention Description
20 mg tablet
Intervention Type
Drug
Intervention Name(s)
AZD2423
Intervention Description
50 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) scale 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
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)
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 RatingScale (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 Scal (NPSI) Total Score.
Description
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.
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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bror Jonzon
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Pleven
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Aalborg
Country
Denmark
Facility Name
Research Site
City
Odense
Country
Denmark
Facility Name
Research Site
City
Boulogne Billancourt
Country
France
Facility Name
Research Site
City
Clermont Ferrand
Country
France
Facility Name
Research Site
City
Nice
Country
France
Facility Name
Research Site
City
Saint-priest En Jarez
Country
France
Facility Name
Research Site
City
Gdansk
Country
Poland
Facility Name
Research Site
City
Katowice
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Poznan
Country
Poland
Facility Name
Research Site
City
Tychy
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Kazan
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Research Site
City
UFA
Country
Russian Federation
Facility Name
Research Site
City
Falköping
Country
Sweden
Facility Name
Research Site
City
Kristianstad
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Birmingham
Country
United Kingdom
Facility Name
Research Site
City
Bradford
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=205&filename=CSR-D2600C00012.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=205&filename=CSR-D2600C00012.pdf
Description
CSR-D2600C00012.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 Posttraumatic Neuralgia..

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