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placebo with 0.09% menthol gel
- Development stage
- Unknown
- Lead developer
- GSK
- Modality
- Small Molecules
- Administration
- Topical
01
Overview
Placebo with 0.09% menthol gel is a topical control formulation developed by GSK for use in Phase III clinical trials, specifically NCT02100670, which evaluated the efficacy of MFC51123 (a diclofenac-menthol combination) for acute ankle sprains. The gel contains a subtherapeutic amount of menthol (0.09%) added solely to provide a scent that mimics the active treatment, thereby ensuring the blinding of participants and investigators. In clinical testing, this placebo served as a comparative baseline to assess the pain-relieving effects of higher-concentration menthol and diclofenac formulations. The trial ultimately found no statistically significant differences between the active combination gel and this placebo in treating pain related to ankle sprain.
- Other names
- Placebo with menthol gel0.09% menthol gel placebo
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