Mentholated Cream Containing Oxygenated Glycerol Triesters on Acute Pain of the Muscles and Joints
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01387750|
Recruitment Status : Completed
First Posted : July 6, 2011
Last Update Posted : July 6, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pain Analgesics||Other: Mentholated Cream Other: Mentholated Cream with OGT||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Evaluating the Efficacy, Tolerance and Acceptability of a Mentholated Cream Containing Oxygenated Glycerol Triesters (OGT) on Acute Pain in Subjects Suffering From a Recent Inflammation of the Muscles and/or Joints|
|Study Start Date :||May 2007|
|Primary Completion Date :||June 2007|
|Study Completion Date :||June 2007|
|Placebo Comparator: Mentholated Cream||
Other: Mentholated Cream
A topical cream containing menthol without the addition of the oxygenated glycerol triesters.
|Active Comparator: Mentholated Cream with OGT||
Other: Mentholated Cream with OGT
A Topical Cream that contained both menthol and oxygenated glycerol triesters.
- Severity of PainPatients were instructed to identify one area on their body where they were experiencing the most acute musculoskeletal pain/discomfort.
- Limitation of ActivityHow limited patient activities were due to the pain associated with the area of interest.
- Evaluation of the mobility of the painful joint/musclePatient assessed how mobile their joints/muscles were within the area of interest.
- Skin ToxicityTolerability 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387750
|Principal Investigator:||Barry T Reece, MS, MBA||RCTS Inc.|
|Study Director:||Jessica Williams, BS||RCTS Inc.|