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The goal of this clinical trial is to test the ability of HT-6184 to decrease inflammation and pain in patients after third molar removal.
The main question it aims to answer are:
Participants will be asked to do the following during the clinical trial:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HT-6184 Treatment Arm | Active Comparator |
| |
| HT-6184 Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HT-6184 | Drug | Single, oral dose of HT-6184 |
| |
| HT-6184 Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum C-reactive protein levels from pre-dose | Up to 54 hours post surgery | |
| Incidence of adverse events | Severity of AEs will be judged according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | Up to 7 days post surgery |
| Incidence of serious adverse events | Severity of AEs will be judged according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | Up to 7 days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the categorical pain intensity-by-time curve (AUCs) | Up to 8 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Halia Study Director | Halia Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel JBR | Murray | Utah | 84107 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| Drug |
Single, oral dose of placebo |
|