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Phase 3Completed

A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain

A Phase 3, Randomized, Double-Blind, Saline Placebo- and Active-Controlled, Multicenter Study to Evaluate the Analgesic Efficacy and Safety of Intra-operative Administration of PRF-110 Following Unilateral Bunionectomy

Sponsor
PainReform LTD (Industry)
Enrollment
428 enrolled
Conditions
Bunion
Interventions
Ropivacaine
Ages
adults, older adults
Registry
NCT05773846

Full record on ClinicalTrials.gov

From the registry

PRF-110 is a viscous, yellowish clear oily solution of ropivacaine intended for administration into surgical sites to provide post-operative analgesia. The pharmacokinetic profile for PRF-110 suggests that its effect could last up to 72 hours. This is A Phase 3, Randomized, Double-Blind, Saline Placebo- and Active-Controlled, Multicenter Study to Evaluate the Analgesic Efficacy and Safety of Intra-operative Administration of PRF-110 Following Unilateral Bunionectomy

Primary outcomes

  • Measurement of patients pain levels as an indication for the analgesic efficacy of PRF-110

History

  1. Last registry update

  2. Study completion

  3. Primary completion

  4. Registered

  5. Started