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| Name | Class |
|---|---|
| Laboratories Carilene | UNKNOWN |
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A single center trial to evaluate the efficacy, tolerance, and acceptability of Oxygenated Glycerol Triesters (OGT) mentholated cream on acute musculoskeletal pain in normal healthy adult volunteers suffering from a recent inflammation of muscles and joints. Patient who met eligibility requirements were instructed to identify one area on their body where they were experiencing the most acute musculoskeletal pain/discomfort. Patients were provided with visual analog scales in order to quantify their pain. Patients either received mentholated cream with or without OGT and instructed to rub on the identified site 3 times a day for 7 days. Pain and other observations were written in a diary for each day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mentholated Cream | Placebo Comparator |
| |
| Mentholated Cream with OGT | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mentholated Cream | Other | A topical cream containing menthol without the addition of the oxygenated glycerol triesters. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Pain | Patients were instructed to identify one area on their body where they were experiencing the most acute musculoskeletal pain/discomfort. |
| Measure | Description | Time Frame |
|---|---|---|
| Limitation of Activity | How limited patient activities were due to the pain associated with the area of interest. | |
| Evaluation of the mobility of the painful joint/muscle | Patient assessed how mobile their joints/muscles were within the area of interest. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barry T Reece, MS, MBA | RCTS, Inc. | Principal Investigator |
| Jessica Williams, BS | RCTS, Inc. | Study Director |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059787 | Acute Pain |
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
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| ID | Term |
|---|---|
| C063057 | UDP-N-acetylglucosamine-peptide beta-N-acetylglucosaminyltransferase |
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| Mentholated Cream with OGT | Other | A Topical Cream that contained both menthol and oxygenated glycerol triesters. |
|
| Skin Toxicity | Tolerability was assessed from Redness and Dryness VAS recorded by the clinical evaluator. No formal safety testing was performed in this study; however anecdotal information (stinging, burning, itching, etc.) was captured on the subjects' diaries. |
| D009140 | Musculoskeletal Diseases |