NCT02257970

Lymphedema Study for Arm or Leg Lymphedema

Placebo-controlled, Case-controlled, Open Label Therapeutic Trial for Unilateral or Bilateral Lymphedema of Arm or Leg.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Part 1 is feasibility, exploratory, open-label study of ketoprofen, to document effects. Part 2, is open-label trial of ketoprofen to document histological response. Part 3 is double-blind randomized trial of receive placebo or ketoprofen to evaluate safety and efficacy. We will try to determine how the study drug affects the body tissue by obtaining tissue biopsies (small pieces of skin from the arm or leg) before treatment and after treatment.

Conditions

• Lymphedema

Interventions

Type	Name	Description
DRUG	Ketoprofen
DRUG	Placebo	Placebo to match ketoprofen.

Timeline

• Start date: 2009-03-01
• Primary completion: 2016-12-01
• Completion: 2017-03-01
• First posted: 2014-10-07
• Last updated: 2022-10-27
• Results posted: 2018-09-14

Locations

1 site across 1 country: United States