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A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with painful diabetic polyneuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD2423, 150 mg | Experimental | Tablets, 150 mg once daily in the morning. |
|
| AZD2423, 20 mg | Experimental | Tablets, 20 mg once daily in the morning. |
|
| Placebo | Placebo Comparator | Tablets, placebo, once daily in the morning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2423 | Drug | 20 mg tablet |
| |
| AZD2423 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score. | Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10; 0=No pain, 10=Worst pain imaginable. | Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score. | Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Worst pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10, 0=No pain, 10=Worst pain imaginable. | Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bror Jonzon | AstraZeneca R&D Södertälje | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Goodyear | Arizona | United States | |||
| Research Site |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
| CSR-D2600C00005.pdf | View source |
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The study had an enrolment phase of up to 35 days (including wash-out and baseline periods), a 28-day treatment phase, and a follow-up phase of 7-14 days. Participants were randomly assigned to blinded treatment in a 1:1:1 ratio either to AZD2423 20 mg, AZD2423 150 mg or placebo.
The first participant was enrolled on 20th September 2010 and the last participant completed on 6th June 2011. A total of 20 centres in United States (US) and Canada randomised 134 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD2423 150 mg | tablets, 150 mg once daily in the morning |
| FG001 | AZD2423 20 mg | tablets, 20 mg once daily in the morning |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
150 mg tablet |
|
| Placebo | Drug | Placebo |
|
| Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. | Last Observation Carried Forward (LOCF). Numerical Rating Scale(NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100. Responder= NRS Average Pain score reduction ≥30% (yes/no) | Baseline (mean of Day -5 to Day -1) to Day 28 |
| Number of Participants With at Least 50% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. | Last Observation Carried Forward (LOCF). Numerical Rating Scale (NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100. Responder= NRS Average Pain score reduction ≥50% (yes/no) | Baseline (mean of Day -5 to Day -1) to Day 28 |
| Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scale (NPSI) Total Score. | Last Observation carried Forward (LOCF). Scale consists of 10 Neuropathic Pain Symptom Inventory Scale (NPSI) pain symptom descriptors wiht a recall period of 24 hours. Each descriptor is rated on a Numerical Rating Scale (NRS) 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Range for total score 0 -100. Higher total score implicates worse symptoms. | Baseline (Day 1) to Day 29 (Visit 7) |
| Phoenix |
| Arizona |
| United States |
| Research Site | Tucson | Arizona | United States |
| Research Site | Los Angeles | California | United States |
| Research Site | DeLand | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Sunrise | Florida | United States |
| Research Site | Madisonville | Kentucky | United States |
| Research Site | Willingboro | New Jersey | United States |
| Research Site | New York | New York | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Winnipeg | Manitoba | Canada |
| Research Site | Brampton | Ontario | Canada |
| Research Site | Etobicoke | Ontario | Canada |
| Research Site | Mississauga | Ontario | Canada |
| Research Site | Lachine | Quebec | Canada |
| Research Site | Laval | Canada |
| FG002 | Placebo | tablets, once daily in the morning |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD2423 150 mg | tablets, 150 mg once daily in the morning |
| BG001 | AZD2423 20 mg | tablets, 20 mg once daily in the morning |
| BG002 | Placebo | tablets, once daily in the morning |
| BG003 | 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 |
|
| 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 From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score. | Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10; 0=No pain, 10=Worst pain imaginable. | Intention-to-treat set (ITT) | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score. | Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Worst pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10, 0=No pain, 10=Worst pain imaginable. | Intention-to-treat set (ITT) | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. | Last Observation Carried Forward (LOCF). Numerical Rating Scale(NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100. Responder= NRS Average Pain score reduction ≥30% (yes/no) | Intention-to-treat set (ITT) | Posted | Number | Participants | Baseline (mean of Day -5 to Day -1) to Day 28 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With at Least 50% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. | Last Observation Carried Forward (LOCF). Numerical Rating Scale (NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100. Responder= NRS Average Pain score reduction ≥50% (yes/no) | Intention-to-treat set (ITT) | Posted | Number | Participants | Baseline (mean of Day -5 to Day -1) to Day 28 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scale (NPSI) Total Score. | Last Observation carried Forward (LOCF). Scale consists of 10 Neuropathic Pain Symptom Inventory Scale (NPSI) pain symptom descriptors wiht a recall period of 24 hours. Each descriptor is rated on a Numerical Rating Scale (NRS) 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Range for total score 0 -100. Higher total score implicates worse symptoms. | Modified Intention- to- treat set (ITT) including only patients with adequate baseline and Day 29 data | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1) to Day 29 (Visit 7) |
|
|
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Safety analysis set
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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 | AZD2423 150 mg | tablets, 150 mg once daily in the morning | 0 | 47 | 14 | 47 | ||
| EG001 | AZD2423 20 mg | tablets, 20 mg once daily in the morning | 3 | 44 | 6 | 44 | ||
| EG002 | Placebo | tablets, once daily in the morning | 0 | 41 | 11 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 |
| ||
| Clostridium difficile colitis | Infections and infestations | MedDRA 10.0 |
| ||
| Myocardial Infarction | Cardiac disorders | MedDRA 10.0 |
| ||
| Sudden cardiac death | General disorders | MedDRA 10.0 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
No such publication or presentation may include any of AstraZeneca's Confidential Information without AstraZeneca's prior written approval. AZ should have 60 days for review and can extend time until submission up to 90 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Bryson | AstraZeneca | clinicaltrialtransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
|
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|
|
| Counts |
|---|
| Participants |
|
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