Transdel Pharmaceuticals is investigating a topical cream formulation consisting of 10% ketoprofen for the local treatment of pain associated with mild to moderate acute soft tissue injury in this confirmatory Phase 3 trial.
This Phase 3 study examines the use of TDLP-110 (a.k.a. Ketotransdel® or ketoprofen 10% cream), as a topical treatment for pain associated with mild to moderate acute soft tissue injury of the upper and lower extremities to serve as a confirmatory trial. The first completed Phase 3 study showed efficacy and safety of TDLP-110 compared to placebo in improving the patient assessment of pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
100 mg (10%) in 1 gram of topical cream applied three times per day for 7 days. Safety follow up on day 14.
Matching placebo cream containing identical constituents as the active comparator except for ketoprofen
Change from baseline in mean pain intensity (100 mm VAS) during daily activities over the past 24 hours at the Day 3 visit (Day 3 +1)
Time frame: 3 days
CPRA; Pain curves over time; Percent change from baseline
* Cumulative proportion of responders for the change from baseline in mean pain intensity as assessed on the 100-mm VAS during daily activities over the past 24 hours at Day 3. * Change from baseline in three-times-daily pain intensity using VAS ratings recorded in the patient diaries over 7 days of treatment. * Percent change from baseline in pain intensity during daily activities over the past 24 hours at Day 3
Time frame: 7 days
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