Lymphedema Study for Arm or Leg Lymphedema

Summary

This study compares the effectiveness of a study drug versus placebo in the treatment of lymphedema.

Timeline

Start

2009-03

Primary completion

2016-12

Completion

2017-03

Outcome

Met primary endpoint

registry analysis (equivalence test); Part 2: Open-label Group; p <0.0001; t-test, 2 sided NCT02257970 ↗

registry analysis (equivalence test); Part 3: Ketoprofen Group; p =0.01; t-test, 2 sided NCT02257970 ↗

paper Histopathology and skin thickness were significantly improved at 4 months compared with baseline. PMID 30333315 ↗

Publications

• Rockson SG, Tian W, Jiang X, Kuznetsova T, Haddad F, Zampell J, Mehrara B, Sampson JP, Roche L, Kim J, Nicolls MR. Pilot studies demonstrate the potential benefits of antiinflammatory therapy in human lymphedema. JCI Insight. 2018 Oct 18;3(20):e123775. doi: 10.1172/jci.insight.123775.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketoprofen	Small molecule	75 mg	Oral
Subject	Ketoprofen	Small molecule	225 mg	Oral
Subject	Ketoprofen	Small molecule	300 mg	Oral

Indications