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:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01200524
First received: September 10, 2010
Last updated: April 11, 2012
Last verified: April 2012
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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 in Numeric Rating Scale Average Pain score [ Time Frame: Baseline (Day -5 to Day -1) to Day 24 to Day 28. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in Numeric Rating Scale Worst Pain score [ Time Frame: Baseline (Day -5 to Day -1) to Day 24 to Day 28. ] [ Designated as safety issue: No ]
- Change from baseline in Numeric Rating Scale Pain Interference on Sleep and Activity score [ Time Frame: Baseline (Day -5 to Day -1) to Day 24 to Day 28. ] [ Designated as safety issue: No ]
- To investigate the safety and tolerability of AZD2423 [ Time Frame: Weekly ] [ Designated as safety issue: No ]
| Enrollment: | 135 |
| 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 |
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 CNS injury/disease, eg. Stroke)
Contacts and Locations
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
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01200524 History of Changes |
| Other Study ID Numbers: | D2600C00012 |
| Study First Received: | September 10, 2010 |
| Last Updated: | April 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Analgesic effect |
Additional relevant MeSH terms:
|
Neuralgia Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms |
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 May 21, 2013