A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee

Summary

The primary purpose of the study is to evaluate the change from baseline after 4 weeks of topical administration of TV-45070 (4% and 8% ointment) compared with placebo for the relief of symptoms of primary OA affecting a single knee

Timeline

Start

2014-04-14

Primary completion

2015-04-06

Completion

2015-05-04

Outcome

Missed primary endpoint

registry analysis (superiority test); TV-45070 4% vs Placebo; p = 0.1213; LSM difference from placebo 4.26 (95% CI -1.13 to 9.66) NCT02068599 ↗

registry analysis (superiority test); TV-45070 8% vs Placebo; p = 0.5231; LSM difference from placebo 1.74 (95% CI -3.62 to 7.11) NCT02068599 ↗

release “TV-45070 4% and 8% did not demonstrate statistically significant difference from placebo in efficacy endpoints in Phase 2b study” xenon-pharma.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	funapide	Small molecule	4 %	Topical
Subject	funapide	Small molecule	8 %	Topical

Indications