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

Nerve Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01200524
• Other study ID #: D2600C00012
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2010
• Last updated: April 8, 2014
• Start date: October 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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 posttraumatic neuralgia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• 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 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nerve Pain

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Bulgaria,  Denmark,  France,  Poland,  Russian Federation,  Sweden,  United Kingdom, 

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) 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	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.	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	No
Secondary	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)	Baseline (mean of Day -5 to Day -1) to Day 28	No
Secondary	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.	Baseline (Day 1) to Day 29 (Visit 7)	No

External Links

•   Link
•   CSR-D2600C00012.pdf