Phase 4
N=50
Lymphedema Study for Arm or Leg Lymphedema
Lymphedema
Bottom Line
View on ClinicalTrials.gov: NCT02257970 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Part 1: Count of Participants Able to Complete Ketoprofen Treatment — 50 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ketoprofen (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Count of Participants Able to Complete Ketoprofen Treatment |
50 | — |
| PRIMARY Part 2: Change From Baseline in Cutaneous Histological Architecture |
6.125; 0.8; 2.688; 0.6 | <0.0001 sig |
| PRIMARY Part 3: Measurement of Skin Thickness |
47; 49; 45; 41 | =0.6 |
| SECONDARY Part 2: Measurement of Skin Thickness |
62; 27 | — |
| SECONDARY Part 3: Change From Baseline in Cutaneous Histological Architecture |
2.7; 4.1; 0.8; 1.0; 1.18; 0.6 | — |
| SECONDARY Part 2/Part 3: Change From Baseline in Bioimpedance Spectroscopy |
1.5; 1.5; 1.4; 1.6; 1.5; 1.4 | — |
| SECONDARY Part 2/Part 3: Change in Limb Volume |
9866; 7196; 8598; 9465; 7256; 8675 | — |
| SECONDARY Part 3: Change in Systemic Inflammatory Mediator Granulocyte Colony Stimulating Factor (G-CSF) |
121; 131; 209; 126 | — |
Summary
This study compares the effectiveness of a study drug versus placebo in the treatment of lymphedema.
Eligibility Criteria
Inclusion Criteria
- a history of lymphedema of one or more limbs (unilateral or bilateral), with a duration of > 6 months.
Exclusion Criteria
- Patients with active cancer, infection or bleeding tendency will be excluded.
- We will also exclude patients with medical contraindications to NSAIDs, including history of allergies, know gastrointestinal intolerance, or other serious systemic illness (e.g., renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would impair the patients' ability to participate.
- Minors ( 90 years of age
Data sourced from ClinicalTrials.gov (NCT02257970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.