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Study to determine the kinetic of the analgesic effect of 500 mg and 1000 mg of Eschscholtzia Californica per os and placebo in patients undergoing dental surgery over an observation period of 6 hours. In a secondary analysis, kinetic of analgesic effect comparison between Eschscholtzia californica 500 mg, 1000 mg and Ibuprofen 200 mg
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eschscholtzia Californica - low dose | Experimental |
| |
| Eschscholtzia Californica - high dose | Experimental |
| |
| Ibuprofen | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eschscholtzia Californica - low dose | Drug |
| ||
| Eschscholtzia Californica - high dose |
| Measure | Description | Time Frame |
|---|---|---|
| VAS-SPID - summed pain intensity differences (SPID) on a VAS (Visual Analogue Scale) | Baseline, up to 6 hours after drug intake |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity differences (PID) on a VAS | Baseline, up to 6 hours after drug intake | |
| Pain intensity difference in the groups on a VAS | Baseline, 2 hours after drug intake | |
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Inclusion Criteria:
Male or female above 18 or below 61 years old
Patient having to undergo a third molar removal from the lower jaw under local troncular anesthesia (articaine + adrenaline)
Type of inclusion of the molar:
Patient suffering from at least moderate to severe pain after surgical removal of an impacted third molar, defined by a 4 point verbal rating scale
Patient's informed consent in accordance with the French legislation
Patient affiliated to the Social Security System
Exclusion Criteria:
Post study exclusion period: the patient will not be able to participate in any other trial for a period of two weeks after the end of this trial
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| Drug |
|
| Ibuprofen | Drug |
|
| Eschscholtzia Californica - low dose Placebo | Drug |
|
| Eschscholtzia Californica - high dose Placebo | Drug |
|
| Ibuprofen Placebo | Drug |
|
| Time point for maximum pain intensity difference on VAS |
| Baseline, up to 6 hours after drug intake |
| Number of patients with a pain decrease of at least 50 % over the all period of observation on a VAS | Baseline, up to 6 hours after drug intake |
| Pain relief at each observed time points on a 5-point verbal rating scale (VRS) | up to 6 hours after drug intake |
| Total pain relief on a 5-point VRS | up to 6 hours after drug intake |
| Global efficacy assessment on a 4-points VRS | 2 and 6 hours after drug intake, day 7 |
| Number of patients requiring a rescue medication | Day 1 |
| Number of patients with adverse events | up to 9 days after treatment |
| Assessment of tolerability by investigator on a 4-point VRS | 6 hours after drug intake, day 7 |
| Assessment of tolerability by subject on a 4-point VRS | 6 hours after drug intake, day 7 |
| 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 |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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