Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy
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Purpose
The purpose of this study is to investigate if AZD2066 can relieve the pain arising from painful diabetic neuropathy compared to placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Diabetic Neuropathy |
Drug: AZD2066 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase IIa, Double-Blind, Randomised, Parallel-Group, Multi-Centre Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy |
- Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment [ Time Frame: From baseline to day 28 ] [ Designated as safety issue: No ]
Change of mean pain intensity from 5-day baseline to the last 5 days of treatment, measured twice daily with NRS (12 hours recall).
Mean pain intensity for 5-day baseline period (evening Day -6 to moning Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the numerical rating scale (NRS)(0-10). 0=No pain, 10=Worst pain imaginable.
- Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28. [ Time Frame: From baseline to 28 days ] [ Designated as safety issue: No ]Mean pain intensity per day (mean of morning and evening NRS values) and change from baseline were calculated for each study day. Baseline value= mean pain intensity for the 5-day baseline period. NRS scale (0- 10) where 0= No pain and 10= Worst pain imaginable.
- Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]Pain intensity score reduction=(change from baseline at D28/baseline)*100 Responder= pain intensity score reduction ≥30% (yes/no)? Responder rate= (no. of responders/total no. of patients)*100
- Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]Pain intensity score reduction= (change from baseline D28/baseline)*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate= (no. of responders/total no. of patients)*100
- Number of Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" at Day 28. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Patient Global Impression of Change (PGIC) scale ranges from 1-7, where 1= Very much improved and 7= Very much worse.
Responder= Patient with a response of "much improved" or "very much improved" Responder rate= (no. of responders/total no. of patients)*100
- Change in McGill Pain Questionnaire Short Form (MPQ-SF) Sensory Index From Baseline to Day 28. [ Time Frame: From baseline to day 28. ] [ Designated as safety issue: No ]
Sensory index= sum of the intensity scale values of the words chosen for the descriptors 1-11 in the questionnaire. Range of scores for the sensory index= 0-33 (higher score represents a worse condition).
Change from baseline (measured prior to randomization) to Day 28 was calculated.
- Change in McGill Pain Questionnaire Short Form (MPQ-SF) Affective Index From Baseline to Day 28. [ Time Frame: From baseline to day 28. ] [ Designated as safety issue: No ]
Affective index= sum of the intensity scale values of the words chosen for the descriptors 12-15 in the questionnaire. Range of scores for the affective index=0-12 (higher score represents a worse condition).
Change from baseline (measured prior to randomization) to Day 28 was calculated.
- Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28. [ Time Frame: From baseline to day 28.. ] [ Designated as safety issue: No ]Change from baseline (measured prior to randomization) to Day 28 was calculated for the pain severity (mean of 4 intensity items). Each intensity item is recorded on a Numerical rating Scale (NRS) 0-10, where 0=No pain and 10= The worst pain.
- Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Interference From Baseline to Day 28. [ Time Frame: From baseline to 28 days ] [ Designated as safety issue: No ]Change from baseline (measured prior to randomization) to Day 28 was calculated for pain interference (mean of 7 interference items). Each interference item is recorded on a Numerical Rating Scale (NRS 0-10), where 0= No interference and 10= Interferes completely.
| Enrollment: | 127 |
| Study Start Date: | February 2009 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: AZD2066
Capsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.
|
| Placebo Comparator: 2 |
Drug: Placebo
Capsule, once daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures.
- Clinical diagnosis of painful diabetic neuropathy.
- non-fertile females
Exclusion Criteria:
- Other pain that may confound assessment of neuropathic pain.
- Ongoing significant peripheral arterial diseases, skin ulcers, or amputation in the lower extremities.
- History of psychotic disorders among first degree relatives.
Contacts and Locations| United States, Arkansas | |
| Reserach Site | |
| Bella Vista, Arkansas, United States | |
| United States, California | |
| Research Site | |
| National City, California, United States | |
| Research Site | |
| Walnut Creek, California, United States | |
| United States, Florida | |
| Research Site | |
| Clearwater, Florida, United States | |
| Research Site | |
| Deland, Florida, United States | |
| Research Site | |
| Lauderdale Lakes, Florida, United States | |
| Research Site | |
| Miami, Florida, United States | |
| Research Site | |
| Orlando, Florida, United States | |
| Research Site | |
| Pembroke Pines, Florida, United States | |
| United States, Kentucky | |
| Research Site | |
| Madisonville, Kentucky, United States | |
| United States, Maryland | |
| Research Site | |
| Owing Mills, Maryland, United States | |
| United States, Michigan | |
| Research Site | |
| Bingham Farms, Michigan, United States | |
| United States, New Jersey | |
| Research Site | |
| Willingboro, New Jersey, United States | |
| United States, New York | |
| Reasearch Site | |
| Albany, New York, United States | |
| United States, North Carolina | |
| Research Site | |
| Winston-Salem, North Carolina, United States | |
| United States, Pennsylvania | |
| Research Site | |
| Indiana, Pennsylvania, United States | |
| Research Site | |
| Philadelphia, Pennsylvania, United States | |
| United States, Texas | |
| Research Site | |
| Houston, Texas, United States | |
| Research Site | |
| San Antonio, Texas, United States | |
| Study Director: | Biljana Lilja | AstraZeneca R&D Södertälje151 85 Södertälje, Sweden |
| Principal Investigator: | Charles E Argoff, MD | Albany Medical , NY 12208, USA |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00857623 History of Changes |
| Other Study ID Numbers: | D0475C00009 |
| Study First Received: | February 27, 2009 |
| Results First Received: | September 28, 2012 |
| Last Updated: | November 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Pain Diabetic Neuropathy PDN Analgesia Efficacy |
Additional relevant MeSH terms:
|
Diabetic Neuropathies Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Diabetes Complications Diabetes Mellitus |
Endocrine System Diseases Signs and Symptoms Poisoning Substance-Related Disorders 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