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A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with posttraumatic neuralgia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD2423, 20mg | Experimental |
| |
| AZD2423, 150 mg | Experimental |
| |
| Placebo | Placebo Comparator | Tablet to match the 20 mg and 50 mg AZD2423 active tablet |
|
| 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) scale 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Pleven | Bulgaria | ||||
| Research Site |
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| Label | URL |
|---|---|
| Related Info | View source |
| CSR-D2600C00012.pdf | View source |
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The study had an enrolment phase of up to 30 days (including wash-out period), 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 6th October 2010 and the last participant completed on 3rd April 2012. A total of 36 centres in France, Denmark, Poland, Russia, UK, Sweden and Bulgaria randomised 133 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD2423, 150 mg | AZD2423 : 3x50 mg tablet once daily in the morning |
| FG001 | AZD2423, 20mg | AZD2423 : 1x20 mg tablet once daily in the morning |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
50 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. | LOCF- Last Observation Carried Forward. 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 RatingScale (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 Scal (NPSI) Total Score. | LOCF- Last Observation Carried Forward. At baseline and at end of treatment the participants filled in their Neuropathic Pain Symptom Inventory Scal (NPSI) pain symptom descriptors, recall period 24 hours. Each descriptor was rated on a NUmerical Rating Scale 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Higher total score is considered worse outcome. | Baseline (Day 1) to Day 29 (Visit 7) |
| Sofia |
| Bulgaria |
| Research Site | Aalborg | Denmark |
| Research Site | Odense | Denmark |
| Research Site | Boulogne-Billancourt | France |
| Research Site | Clermont-Ferrand | France |
| Research Site | Nice | France |
| Research Site | Saint-Priest-en-Jarez | France |
| Research Site | Gdansk | Poland |
| Research Site | Katowice | Poland |
| Research Site | Krakow | Poland |
| Research Site | Poznan | Poland |
| Research Site | Tychy | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Kazan' | Russia |
| Research Site | Moscow | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Ufa | Russia |
| Research Site | Falköping | Sweden |
| Research Site | Kristianstad | Sweden |
| Research Site | Stockholm | Sweden |
| Research Site | Birmingham | United Kingdom |
| Research Site | Bradford | United Kingdom |
| Research Site | Glasgow | United Kingdom |
| Research Site | Manchester | United Kingdom |
| FG002 | Placebo | Tablet to match the 20 mg and 50 mg AZD2423 active tablet Placebo : Placebo |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD2423, 150 mg | AZD2423 : 3x50 mg tablet once daily in the morning |
| BG001 | AZD2423, 20mg | AZD2423 : 1x20 mg tablet once daily in the morning |
| BG002 | Placebo | Tablet to match the 20 mg and 50 mg AZD2423 active tablet Placebo : Placebo |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | 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 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) scale 0-10. 0= No pain, 10= Worst pain imaginable. | mITT analysis set including only those that had adequate NRS data at baseline and Days 24-28 | 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 |
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| 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. | mITT analysis set including only those that had adequate NRS data at baseline and Days 24-28 | 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 |
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| Secondary | Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. | LOCF- Last Observation Carried Forward. 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) | mITT analysis set | Posted | Number | Participants | Baseline (mean of Day -5 to Day -1) to Day 28 |
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| Secondary | Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (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) | mITT analysis set | Posted | Number | Participants | Baseline (mean of Day -5 to Day -1) to Day 28 |
|
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| Secondary | Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score. | LOCF- Last Observation Carried Forward. At baseline and at end of treatment the participants filled in their Neuropathic Pain Symptom Inventory Scal (NPSI) pain symptom descriptors, recall period 24 hours. Each descriptor was rated on a NUmerical Rating Scale 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Higher total score is considered worse outcome. | mITT analysis set including only those that had adequate NPSI data at baseline and Day 29 | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1) to Day 29 (Visit 7) |
|
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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 | AZD2423 : 3x50 mg tablet once daily in the morning | 0 | 41 | 14 | 41 | ||
| EG001 | AZD2423, 20mg | AZD2423 : 1x20 mg tablet once daily in the morning | 0 | 48 | 14 | 48 | ||
| EG002 | Placebo | Tablet to match the 20 mg and 50 mg AZD2423 active tablet Placebo : Placebo | 0 | 44 | 10 | 44 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Asthenia | General disorders |
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| Nasopharyngitis | Infections and infestations |
| |||
| Headache | Nervous system disorders |
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The agreement restricts the PI's rights to discuss or publish trial results after the trial is completed. No publication or presentation may include any of AZ's Confidential Information without AZ'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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| Black or African American |
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| Units |
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| Counts |
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| Participants |
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