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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No. 2007-005470-31 |
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The study is being performed in order to learn more about the safety and tolerability of AZD1386. AZD1386 is primary intended for treatment of chronic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD1386 | Experimental | 7 groups receiving a specified volume of the active component AZD1386 at different points of time. |
|
| Placebo | Placebo Comparator | 7 groups receiving a specified volume of placebo at different points of time |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1386 | Drug | Oral admin. of doses at 11 days through a 12 days period. Cmax = 16 mikromol/L and AUCmax = 98 mikromol*h/L |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety AEs and vital signs | During the whole study | |
| ECG-recordings | ECGs (5 minutes) Days 1 and 12. 2 ECGs (5 minutes) Days 3, 6 and 10. 1 ECG (5 minutes) Days 2 and 13. |
| Measure | Description | Time Frame |
|---|---|---|
| PK | Days 1, 5 and 12, 12 times each day. Days 4, 6, 8, 10 and 14, once. Days 2, 3, 7, 9, 11 and 13 twice. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rolf Karlsten | Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden | Study Director |
| Ray Chetty | AstraZeneca Alderly Park1G61 Mereside, Alderly Park, Macclesfeld, Cheshire, England SK104TG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Macclesfield | Cheshire | United Kingdom |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C574562 | AZD1386 |
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| Placebo | Drug | Oral admin. of doses at 11 days through a 12 days period. |
|