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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01200524
First received: September 10, 2010
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with posttraumatic neuralgia.


Condition Intervention Phase
Nerve Pain
Drug: AZD2423
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline (mean of Day -5 to Day -1) to Day 28 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline (mean of Day -5 to Day -1) to Day 28 ] [ Designated as safety issue: No ]

    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. [ Time Frame: Baseline (Day 1) to Day 29 (Visit 7) ] [ Designated as safety issue: No ]
    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.


Enrollment: 133
Study Start Date: October 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD2423, 20mg Drug: AZD2423
20 mg tablet
Experimental: AZD2423, 150 mg Drug: AZD2423
50 mg tablet
Placebo Comparator: Placebo
Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200524

Locations
Bulgaria
Research Site
Pleven, Bulgaria
Research Site
Sofia, Bulgaria
Denmark
Research Site
Aalborg, Denmark
Research Site
Odense, Denmark
France
Research Site
Boulogne Billancourt, France
Research Site
Clermont Ferrand, France
Research Site
Nice, France
Research Site
Saint-priest En Jarez, France
Poland
Research Site
Gdansk, Poland
Research Site
Katowice, Poland
Research Site
Krakow, Poland
Research Site
Poznan, Poland
Research Site
Tychy, Poland
Research Site
Warszawa, Poland
Russian Federation
Research Site
Kazan, Russian Federation
Research Site
Moscow, Russian Federation
Research Site
St. Petersburg, Russian Federation
Research Site
UFA, Russian Federation
Sweden
Research Site
Falköping, Sweden
Research Site
Kristianstad, Sweden
Research Site
Stockholm, Sweden
United Kingdom
Research Site
Birmingham, United Kingdom
Research Site
Bradford, United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
Manchester, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Bror Jonzon AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01200524     History of Changes
Other Study ID Numbers: D2600C00012
Study First Received: September 10, 2010
Results First Received: July 25, 2013
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Analgesic effect

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014