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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
The purpose of this study is to investigate if 28 days of treatment with AZD2066 compared to placebo can relieve the pain arising from the nervous system when the patients are touched by something that should not cause pain or have severe pain when they are touched by something that should only cause a little pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2066 | Drug | Capsule, once daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Numerical Rating Scale (NRS) Pain Score From Baseline to Last 5 Days on Treatment | Mean pain intensity for 5-day baseline period (morning Day -5 to evening 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 NRS scale (0-10). 0=No pain, 10=Worst pain imaginable. | Change in mean pain intensity from 5-day baseline to the last 5 days on treatment, measure twice daily with NRS (12-hour recall) |
| Measure | Description | Time Frame |
|---|---|---|
| Patients With ≥30% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28 | NRS pain intensity score reduction=(change from baseline at Day 28/baseline)*100 Responder=pain intensity score reduction ≥30% (yes/no)? Responder rate=(no. of responders/total no. of patients)*100 | 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 |
| Brett Stacey | Oregon Health and Science University Comprehensive Pain Clinic, Portland, OR 97239, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tucson | Arizona | United States | |||
| Research Site |
The study had an enrolment phase of up to 35 days (including washout and baseline periods), a 28-day treatment phase, and a follow-up phase of 7 days (for men and women not of childbearing potential) or 28 days (for women of childbearing potential). Patients randomized to AZD2066 received AZD2066 12 mg from Days 1 to 4 and 18 mg from Days 5 to 28.
This multicenter study was conducted between August 2009 and November 2010 in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | A - AZD2066 | AZD2066, 12 mg capsule |
| FG001 | 2 - Placebo | Placebo, capsule |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Capsule, once daily |
|
| Patients With ≥50% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28 |
Pain intensity score reduction=(change from baseline Day 28/baseline)*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate=(no. of responders/total no. of patients)*100 |
| 28 days |
| Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" (Responder Rate) at Day 28 | 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 Short Form McGill Pain Questionnaire (SF-MPQ) 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. | 28 days |
| Change in SF-MPQ 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. | 28 days |
| 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 NRS 0-10, where 0=No Pain and 10=Pain as bad as you can imagine. | 28 days |
| Change in 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 NRS 0-10, where 0=No interference and 10=Interferes completely. | 28 days |
| Los Angeles |
| California |
| United States |
| Research Site | Sacramento | California | United States |
| Research Site | San Francisco | California | United States |
| Research Site | Walnut Creek | California | United States |
| Research Site | Boulder | Colorado | United States |
| Research Site | Atlantis | Florida | United States |
| Research Site | Aventura | Florida | United States |
| Research Site | Clearwater | Florida | United States |
| Research Site | Fort Myers | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Palm Beach Gardens | Florida | United States |
| Research Site | Sarasota | Florida | United States |
| Research Site | St. Petersburg | Florida | United States |
| Research Site | Sunrise | Florida | United States |
| Research Site | Canton | Georgia | United States |
| Research Site | Marietta | Georgia | United States |
| Research Site | Evansville | Indiana | United States |
| Research Site | New Orleans | Louisiana | United States |
| Research Site | Brockton | Massachusetts | United States |
| Research Site | Bingham Farms | Michigan | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Reno | Nevada | United States |
| Research Site | Lumberton | New Jersey | United States |
| Research Site | Willingboro | New Jersey | United States |
| Research Site | Albuquerque | New Mexico | United States |
| Research Site | Jacksonville | North Carolina | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Kettering | Ohio | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Bridgeville | Pennsylvania | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Irving | Texas | United States |
| Research Site | Lexington | Texas | United States |
| Research Site | Longview | 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 | A - AZD2066 | AZD2066, 12 mg capsule |
| BG001 | 2 - Placebo | Placebo, capsule |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | 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) Pain Score From Baseline to Last 5 Days on Treatment | Mean pain intensity for 5-day baseline period (morning Day -5 to evening 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 NRS scale (0-10). 0=No pain, 10=Worst pain imaginable. | Posted | Least Squares Mean | Standard Error | Scores (units) on NRS | Change in mean pain intensity from 5-day baseline to the last 5 days on treatment, measure twice daily with NRS (12-hour recall) |
|
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| Secondary | Patients With ≥30% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28 | NRS pain intensity score reduction=(change from baseline at Day 28/baseline)*100 Responder=pain intensity score reduction ≥30% (yes/no)? Responder rate=(no. of responders/total no. of patients)*100 | Posted | Number | Participants | 28 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Patients With ≥50% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28 | Pain intensity score reduction=(change from baseline Day 28/baseline)*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate=(no. of responders/total no. of patients)*100 | Posted | Number | Participants | 28 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" (Responder Rate) at Day 28 | 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 | Posted | Number | Patients | 28 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Change in Short Form McGill Pain Questionnaire (SF-MPQ) 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. | Posted | Least Squares Mean | Standard Error | Scores (units) on SF-MPQ Sensory Index | 28 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change in SF-MPQ 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. | Posted | Least Squares Mean | Standard Deviation | Scores (units) on SF-MPQ Affective Index | 28 days |
|
| ||||||||||||||||||||||||||||||
| 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 NRS 0-10, where 0=No Pain and 10=Pain as bad as you can imagine. | Posted | Least Squares Mean | Standard Error | Scores (units) on BPI-SF pain severity | 28 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change in 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 NRS 0-10, where 0=No interference and 10=Interferes completely. | Posted | Least Squares Mean | Standard Error | Scores on BPI-SF pain interference | 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 | A - AZD2066 | AZD2066, 12 mg capsule | 1 | 42 | 30 | 42 | ||
| EG001 | 2 - Placebo | Placebo, capsule | 0 | 44 | 15 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychotic Disorder | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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Early termination of study for safety reasons leading to fewer subjects analyzed than originally planned.
No publication or presentation with respect to the study until the earlier of 1) publication of the first Multi-Center Publication and 2) the second anniversary of the completion, or termination of the study.
Sponsor to review at least 60 days prior submission. Sponsor can withhold material for submission for additional 90 days
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010146 | Pain |
| D006930 | Hyperalgesia |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| C587779 | AZD2066 |
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| Male |
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