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The primary aim of this study is to investigate if AZD1386 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain. A number of patients will instead receive the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen, will be allowed if a need for additional painkillers would arise. A number of patients will receive naproxen as control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD1386 | Experimental |
| |
| Naproxen | Active Comparator |
| |
| Placebo | Placebo Comparator | Placebo matching AZD1386 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1386 | Drug | 95mg, oral solution, single dose |
| |
| Naproxen |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Difference in Percent (SPID%) | Weighted sum of the pain intensity (PI) differences in percent for the given time frame. PI values are weighted according to the time since the previous PI assessment (or the time of administration of the investigational product for the first post-dose assessment). SPID% = elapsed since previous value, where is the PI difference in percent at assessment t. High values=good effect, low values=poor effect Pointwise assessments of pain are measured using a VAS scale (0-100 mm), as described in the secondary outcome measure (PI). | from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm) | 0 = 'No pain' 100 ='Worst pain imaginable' Up to 16 individual assessments were performed and contained in the derived primary outcome measure, thus not reported separately. | Immediately prior to administration of investigational product (IP). After intake of IP assessment will be made every 15 min for the first 2 h, at 2h and 30 min, 3 h and thereafter every hour up to 8 h after intake of IP. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynn Webster, MD | Lifetree Clinical Research3838 South, 700 East, Suite 202Salt Lake City, Utah 84106, USA | Principal Investigator |
| Bror Jonzon | AstraZeneca R&D Södertälje, SE-151 85 Södertälje, Sweden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Salt Lake City | Utah | United States |
Screening for eligibility prior to the residential day, and selecting the patients that request pain relief, due to pain from the dental surgical area, within 6 hours after the end of the administration of the local anaesthetic.
The study was performed at Lifetree Clinical Research, Salt Lake City, USA, during April-June 2008.
135 participants enrolled in the study, 103 randomized and 99 patients completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD1386 | AZD1386 95 mg oral solution |
| FG001 | Naproxen | Naproxen 500 mg capsule |
| FG002 | Placebo | AZD1386 Placebo oral solution |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD1386 | AZD1386 95 mg oral solution |
| BG001 | Naproxen | Naproxen 500 mg capsule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Sum of Pain Intensity Difference in Percent (SPID%) | Weighted sum of the pain intensity (PI) differences in percent for the given time frame. PI values are weighted according to the time since the previous PI assessment (or the time of administration of the investigational product for the first post-dose assessment). SPID% = elapsed since previous value, where is the PI difference in percent at assessment t. High values=good effect, low values=poor effect Pointwise assessments of pain are measured using a VAS scale (0-100 mm), as described in the secondary outcome measure (PI). | Posted | Median | Full Range | percentage of pain intensity change * h | from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours |
|
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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 | AZD1386 | AZD1386 95 mg oral solution |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CHILLS | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| 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 |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Drug |
500mg, capsule, single dose |
|
| Placebo | Drug | AZD1386 Placebo oral solution |
|
| Time to First Perceptible Pain Relief | First perceptible pain relief is the time at which the participant begins to feel any pain relief at all. The time to first perceptible pain relief was reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first perceptible pain relief, and participants who report first perceptible pain relief after rescue intake, have the corresponding time censored to 8 hours. | from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours |
| Time to First Meaningful Pain Relief | First meaningful pain relief is the time when the participant's pain relief feels meaningful. The time to first meaningful pain relief will be reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first meaningful pain relief, and participants who report first meaningful pain relief after rescue intake, have the corresponding time censored to 8 hours. | from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours |
| VAS Pain Intensity at Rescue Intake | 0 = 'No pain' 100 ='Worst pain imaginable' | at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product |
| VAS Pain on Jaw Movement at Rescue Intake | 0 = 'No pain' 100 ='Worst pain imaginable' | at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product |
| BG002 |
| Placebo |
AZD1386 Placebo oral solution |
| BG003 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Naproxen |
Naproxen 500 mg capsule |
| OG002 | Placebo | AZD1386 Placebo oral solution |
|
|
| Secondary | Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm) | 0 = 'No pain' 100 ='Worst pain imaginable' Up to 16 individual assessments were performed and contained in the derived primary outcome measure, thus not reported separately. | Posted | Median | Full Range | units on VAS scale | Immediately prior to administration of investigational product (IP). After intake of IP assessment will be made every 15 min for the first 2 h, at 2h and 30 min, 3 h and thereafter every hour up to 8 h after intake of IP. |
|
|
|
| Secondary | Time to First Perceptible Pain Relief | First perceptible pain relief is the time at which the participant begins to feel any pain relief at all. The time to first perceptible pain relief was reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first perceptible pain relief, and participants who report first perceptible pain relief after rescue intake, have the corresponding time censored to 8 hours. | Posted | Median | Inter-Quartile Range | hour | from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours |
|
|
|
| Secondary | Time to First Meaningful Pain Relief | First meaningful pain relief is the time when the participant's pain relief feels meaningful. The time to first meaningful pain relief will be reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first meaningful pain relief, and participants who report first meaningful pain relief after rescue intake, have the corresponding time censored to 8 hours. | Posted | Median | Inter-Quartile Range | hour | from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours |
|
|
|
| Secondary | VAS Pain Intensity at Rescue Intake | 0 = 'No pain' 100 ='Worst pain imaginable' | Only participants that took rescue medication are included in this analysis. | Posted | Median | Full Range | units on a VAS scale | at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product |
|
|
|
| Secondary | VAS Pain on Jaw Movement at Rescue Intake | 0 = 'No pain' 100 ='Worst pain imaginable' | Only participants that took rescue medication are included in this analysis. | Posted | Median | Full Range | Units on a VAS scale | at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product |
|
|
|
| 0 |
| 40 |
| 4 |
| 40 |
| EG001 | Naproxen | Naproxen 500 mg capsule | 0 | 23 | 0 | 23 |
| EG002 | Placebo | AZD1386 Placebo oral solution | 0 | 40 | 6 | 40 |
| DIZZINESS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
AstraZeneca has the exclusive right to publish the results of the study.
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
|
| 30 minutes |
|
| 45 minutes |
|
| 1 hour |
|
| 1 hour 15 minutes |
|
| 1 hour 30 minutes |
|
| 1 hour 45 minutes |
|
| 2 hours |
|
| 2 hours 30 minutes |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| 7 hours |
|
| 8 hours |
|