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The purpose of this study is to investigate if AZD2066 can relieve the pain arising from painful diabetic neuropathy compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2066 | Drug | Capsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment | 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. | From baseline to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28. | 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. | From baseline to 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Biljana Lilja | AstraZeneca R&D Södertälje151 85 Södertälje, Sweden | Study Director |
| Charles E Argoff, MD | Albany Medical , NY 12208, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reserach Site | Bella Vista | Arkansas | United States | |||
| Research Site |
The study consisted of a 42-day enrollment phase (including washout and baseline period), a 28-day treatment phase (10-day inpatient and 18-day outpatient) where patients were randomized to AZD2066 or placebo, and a 7-day follow-up phase. Patients randomized to treatment with AZD2066 received 12 mg from Days 1 to 4 and 18 mg from Days 5 to 28.
This multicenter study was conducted between February 2009 and August 2009in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD2066 | Capsule, once daily. 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28. |
| FG001 | Placebo | Capsule, once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo |
| Drug |
Capsule, once daily |
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| Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28 | 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 | 28 days |
| Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28 | 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 | 28 days |
| Number of Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" at Day 28. | 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 | 28 days |
| Change in McGill Pain Questionnaire Short Form (MPQ-SF) Sensory Index From Baseline to Day 28. | 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. | From baseline to day 28. |
| Change in McGill Pain Questionnaire Short Form (MPQ-SF) Affective Index From Baseline to Day 28. | 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. | From baseline to day 28. |
| Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28. | 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. | From baseline to day 28.. |
| Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Interference From Baseline to Day 28. | 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. | From baseline to 28 days |
| National City |
| California |
| United States |
| Research Site | Walnut Creek | California | United States |
| 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 |
| Research Site | Madisonville | Kentucky | United States |
| Research Site | Owing Mills | Maryland | United States |
| Research Site | Bingham Farms | Michigan | United States |
| Research Site | Willingboro | New Jersey | United States |
| Reasearch Site | Albany | New York | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Indiana | Pennsylvania | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Houston | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD2066 | Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28 |
| BG001 | Placebo | Capsule, once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | All randomized patients. | Mean | Standard Deviation | years |
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| Sex: Female, Male | All randomized patients. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment | 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. | Per Protocol population (PP) | Posted | Least Squares Mean | Standard Error | Scores on a scale | From baseline to day 28 |
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| Secondary | Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28. | 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. | Per Protocol population (PP) | Posted | Mean | Standard Deviation | Scores on a scale | From baseline to 28 days |
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| Secondary | Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28 | 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 | Per Protocol population (PP) | Posted | Number | Participants | 28 days |
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| Secondary | Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28 | 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 | Per Protocol population (PP) | Posted | Number | Participants | 28 days |
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| Secondary | Number of Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" at Day 28. | 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 | Per Protocol population (PP) | Posted | Number | Participants | 28 days |
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| Secondary | Change in McGill Pain Questionnaire Short Form (MPQ-SF) Sensory Index From Baseline to Day 28. | 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. | Per Protocol population (PP) | Posted | Least Squares Mean | Standard Error | Scores on a scale | From baseline to day 28. |
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| Secondary | Change in McGill Pain Questionnaire Short Form (MPQ-SF) Affective Index From Baseline to Day 28. | 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. | Per Protocol population (PP) | Posted | Least Squares Mean | Standard Error | Scores on a scale | From baseline to day 28. |
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| Secondary | Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28. | 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. | Per Protocol population (PP) | Posted | Least Squares Mean | Standard Error | Scores on a scale | From baseline to day 28.. |
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| Secondary | Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Interference From Baseline to Day 28. | 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. | Per Protocol population (PP) | Posted | Least Squares Mean | Standard Error | Scores on a scale | From baseline to 28 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD2066 | Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28 | 1 | 62 | 19 | 62 | ||
| EG001 | Placebo | Capsule, once daily | 1 | 65 | 20 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 12.0 |
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| Cardiac failure congestive; Myocardial infarction | Cardiac disorders | MedDRA 12.0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 12.0 |
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| Dizziness | Nervous system disorders | MedDRA 12.0 |
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| Diarrhea | Gastrointestinal disorders | MedDRA 12.0 |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D010146 | Pain |
| D003929 | Diabetic Neuropathies |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| C587779 | AZD2066 |
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| Male |
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