A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01201317
First received: September 13, 2010
Last updated: December 22, 2011
Last verified: December 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with painful diabetic polyneuropathy.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuropathic Pain |
Drug: AZD2423 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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 |
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 Mean of 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 Mean of Day 24 to Day 28 ] [ Designated as safety issue: No ]
- Responder rate (defined as at least 30% decrease from baseline in Numeric Rating Scale Average Pain score) at Day 28 [ Time Frame: Baseline (Day -5 to Day -1) to Day 28 ] [ Designated as safety issue: No ]
- Responder rate (defined as at least 50% decrease from baseline in Numeric Rating Scale Average Pain score)at Day 28 [ Time Frame: Baseline (Day -5 to Day -1) to Day 28 ] [ Designated as safety issue: No ]
- Change from baseline to Day 29 in NPSI Total score [ Time Frame: Baseline (Day 1) to Day 29 (Visit 7) ] [ Designated as safety issue: No ]
| Enrollment: | 135 |
| Study Start Date: | September 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
AZD2423 20 mg
|
Drug: AZD2423
20 mg tablet
|
|
Experimental: 2
AZD2423 150 mg
|
Drug: AZD2423
50 mg tablet
|
|
Placebo Comparator: 3
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 of non-child bearing potential patients aged 18 to 80 years
- Patients with neuropathic pain due to painful diabetic polyneuropathy.
Exclusion Criteria:
- Other paint 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 CNS injury/disease, eg. Stroke)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201317
Locations
| United States, Arizona | |
| Research Site | |
| Goodyear, Arizona, United States | |
| Research Site | |
| Phoenix, Arizona, United States | |
| Research Site | |
| Tucson, Arizona, United States | |
| United States, California | |
| Research Site | |
| Los Angeles, California, United States | |
| United States, Florida | |
| Research Site | |
| Deland, Florida, United States | |
| Research Site | |
| Miami, Florida, United States | |
| Research Site | |
| Orlando, Florida, United States | |
| Research Site | |
| Sunrise, Florida, United States | |
| United States, Kentucky | |
| Research Site | |
| Madisonville, Kentucky, United States | |
| United States, New Jersey | |
| Research Site | |
| Willingboro, New Jersey, United States | |
| United States, New York | |
| Research Site | |
| New York, New York, United States | |
| United States, North Carolina | |
| Research Site | |
| Winston-salem, North Carolina, United States | |
| United States, Pennsylvania | |
| Research Site | |
| Philadelphia, Pennsylvania, United States | |
| United States, Texas | |
| Research Site | |
| Houston, Texas, United States | |
| Canada, Manitoba | |
| Research Site | |
| Winnipeg, Manitoba, Canada | |
| Canada, Ontario | |
| Research Site | |
| Brampton, Ontario, Canada | |
| Research Site | |
| Etobicoke, Ontario, Canada | |
| Research Site | |
| Mississauga, Ontario, Canada | |
| Canada, Quebec | |
| Research Site | |
| Lachine, Quebec, Canada | |
| Canada | |
| Research Site | |
| Laval, Canada | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Bror Jonzon | AstraZeneca R&D Södertälje |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01201317 History of Changes |
| Other Study ID Numbers: | D2600C00005 |
| Study First Received: | September 13, 2010 |
| Last Updated: | December 22, 2011 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by AstraZeneca:
|
Analgesic effect |
Additional relevant MeSH terms:
|
Neuralgia Diabetic Neuropathies Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Diabetes Complications |
Diabetes Mellitus Endocrine System Diseases 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 19, 2013