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临床试验/NCT02257970
NCT02257970已完成4 期

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

Stanford University1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
117
试验地点
1
主要终点
Part 3: Measurement of Skin Thickness

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • a history of lymphedema of one or more limbs (unilateral or bilateral), with a duration of > 6 months.

排除标准

  • 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 (<18 years of age) *>90 years of age

研究组 & 干预措施

Part 3: Placebo Group

Placebo Comparator

Participants randomized to receive placebo: placebo, three times daily, taken orally

Placebo: 1 capsule, three times daily, for four months

干预措施: Placebo (Drug)

Part 1: Exploratory Group

Experimental

Ketoprofen 225-300 mgs daily, taken orally

Ketoprofen-exploratory group: 225-300 mgs daily for four to six months

干预措施: Ketoprofen (Drug)

Part 2: Open-label Group

Experimental

Ketoprofen 225 mg daily, taken orally

Open-label group: 75 mgs, three times daily, for four months

干预措施: Ketoprofen (Drug)

Part 3: Ketoprofen Group

Active Comparator

Participants randomized to receive active medication: ketoprofen 75 mgs., three times daily, taken orally

Ketoprofen: 1 capsule, three times daily, for four months

干预措施: Ketoprofen (Drug)

结局指标

主要结局

Part 3: Measurement of Skin Thickness

时间窗: Baseline and 4 months

Caliper-measured skin thickness (mm) was serially assessed and pre-to-post paired analysis was performed for both arms (Placebo and Ketoprofen) of the study.

Part 1: Count of Participants Able to Complete Ketoprofen Treatment

时间窗: Baseline to month 6

Participants who were able to complete ketoprofen treatment and experienced no treatment-related serious adverse events.

Part 2: Change From Baseline in Cutaneous Histological Architecture

时间窗: Baseline; Month 4

Quantitative assessment of paired histological specimens of lymphedema skin pre- and post-treatment with ketoprofen. The impact of treatment on cutaneous histopathology was evaluated through the use of an empirically-derived scoring system (comprised of dermal thickness, intercellular mucin content, deep dermal collagen content, and perivascular infiltrate); this quantitative assessment was developed and performed by a dermatopathologist. Each characteristic was weighted equally and each specimen was assigned a cumulative subscale score of 0-5. The scores were summed for a total score (range: 0-20) which is presented here. Higher scores indicate a higher degree of pathology. A quantitatively higher negative change indicates a more favorable therapeutic response in the histology.

次要结局

  • Part 3: Change From Baseline in Cutaneous Histological Architecture(Baseline; 4 months)
  • Part 2: Measurement of Skin Thickness(Baseline and 4 months)
  • Part 2/Part 3: Change From Baseline in Bioimpedance Spectroscopy(Baseline; 4 months)
  • Part 2/Part 3: Change in Limb Volume(Baseline; 4 months)
  • Part 3: Change in Systemic Inflammatory Mediator Granulocyte Colony Stimulating Factor (G-CSF)(Baseline; 4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stanley Rockson

Allan and Tina Neill Professor of Lymphatic Research and Medicine; Professor of Cardiovascular Medicine

Stanford University

研究点 (1)

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