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

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201317
• Other study ID #: D2600C00005
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2010
• Last updated: April 8, 2014
• Start date: September 2010
• Est. completion date: June 2011

Study information

• Verified date: April 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• AZD2423
20 mg tablet
• AZD2423
150 mg tablet
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	Research Site	Brampton	Ontario
Canada	Research Site	Etobicoke	Ontario
Canada	Research Site	Lachine	Quebec
Canada	Research Site	Laval
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Winnipeg	Manitoba
United States	Research Site	Deland	Florida
United States	Research Site	Goodyear	Arizona
United States	Research Site	Houston	Texas
United States	Research Site	Los Angeles	California
United States	Research Site	Madisonville	Kentucky
United States	Research Site	Miami	Florida
United States	Research Site	New York	New York
United States	Research Site	Orlando	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Sunrise	Florida
United States	Research Site	Tucson	Arizona
United States	Research Site	Willingboro	New Jersey
United States	Research Site	Winston-salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28	No
Secondary	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.	Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28	No
Secondary	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)	Baseline (mean of Day -5 to Day -1) to Day 28	No
Secondary	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)	Baseline (mean of Day -5 to Day -1) to Day 28	No
Secondary	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.	Baseline (Day 1) to Day 29 (Visit 7)	No

External Links

•   Link
•   CSR-D2600C00005.pdf