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Phase 2Completed

Safety and Activity of F14 for Management of Pain Following Total Knee Replacement

A Phase 2, Randomized, Single-Blind, Active-Control, Parallel Group Study to Evaluate Safety and Activity of a Single Administration of F14 for Management of Postoperative Pain in Participants Undergoing Unilateral Total Knee Replacement

Sponsor
Arthritis Innovation Corporation (Industry)
Enrolment
20 enrolled
Conditions
Total Knee Replacement; Postoperative Pain
Interventions
Bupivacaine HCl; F14 (celecoxib)
Ages
adults, older adults
Registry
NCT03541655

Full record on ClinicalTrials.gov

From the registry

The safety and activity of a single, 3.5 mL dose of F14 (celecoxib) concurrent with standard of care analgesia administered following total knee replacement will be compared to standard of care analgesia alone.

Primary outcomes

  • Peak pain intensity measured by visual analog scale (VAS)
  • Area under the curve (AUC) of visual analog scale (VAS) pain intensity scores
  • Summed pain intensity difference (SPID) of visual analog scale (VAS) pain intensity scores
  • Functional improvement by Timed Up and Go test

History

  1. Last registry update

  2. Study completion

  3. Primary completion

  4. Registered

  5. Started