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| Name | Class |
|---|---|
| iX Biopharma Ltd. | OTHER |
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This is a Phase 2, randomized, multicenter, parallel group, double-blind, dose-ranging, placebo-controlled evaluation of the analgesic efficacy, safety and pharmacokinetics of ketamine sublingual wafer in adult subjects who experience post operative pain after undergoing third molar extraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| ketamine 25 mg | Active Comparator | ketamine |
|
| ketamine 35 mg | Active Comparator | ketamine |
|
| ketamine 50 mg | Active Comparator | ketamine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | placebo |
| |
| ketamine 25 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Difference | The primary objective of this study is to demonstrate the dose-response relationship for analgesia of three dose levels of ketamine sublingual wafer compared with placebo, using the summed pain intensity difference from baseline over the first 3 hours (SPID3) in subjects with acute moderate to severe pain following third molar extraction. | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Difference | SPID 6 | 6 hours |
| Safety and tolerability | Safety and tolerability of ketamine sublingual wafer as evaluated with physical examination, vital signs, pulse oximetry, clinical laboratory tests, ECGs, and incidence of Adverse Events (AEs) and Serious AEs (SAEs) |
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18- 38 years of age Scheduled to undergo two ipsilateral third molar extractions
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lotus Clinical Research, LLC | Pasadena | California | 91105 | United States | ||
| Prahealthsciences |
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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 |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
ketamine |
|
| ketamine 35 mg | Drug | ketamine |
|
| ketamine 50 mg | Drug | ketamine |
|
| 6 hours |
| Salt Lake City |
| Utah |
| 84106 |
| United States |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |