Randomized Placebo-controlled Multi-center Study of Efficacy and Safety of a CFA-based Topical Cream Cetilar®️ in Patients With Ankle Injury or Chronic Trauma to the Ankle
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Change From Baseline in FAAM (Foot and Ankle Ability and Measure) total score questionnaire on day 30
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and efficacy of Cetilar®
详细描述
After being informed about the study, all patients giving written informed consent will undergo no more than a 1-week screening period to determine eligibility for study entry. Patients that meet inclusion criteria and do not have exclusion criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Cetilar® cream (about 5 g, twice per day) or placebo cream (about 5 g, twice per day).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signing the Patient Information Sheet and Informed Consent Form
- •Patients with reduced ankle mobility caused by injury or chronic trauma to the ankle
- •Men or women aged ≥20 and ≤80 years
- •Patients who mark the pain 4 cm on a VAS
- •Patients who are willing or able to follow doctor's instructions
- •Patients not participating in other clinical trials within 30 days before the screening
- •Patients who have received sufficient explanation for this clinical trial and agreed to participate
排除标准
- •Patients who received intraarticular injection treatment into the painful area within 3 months prior to the first visit
- •Ankle surgery in the previous six months
- •Topical NSAIDs application during the treatment period
- •Systemic inflammatory diseases (e.g. fibromyalgia, etc.)
- •Progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease)
- •Patients with major infections in the observation period
- •Renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values)
- •Liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range)
- •Patients with serious heart-related diseases such as cardiac arrest, a history of cerebral infarction, or ischemic heart disease
- •Patients who received systemic steroid treatment within 1 month prior to their first visit
- •Diabetic foot
- •Pregnant or lactating women
结局指标
主要结局
Change From Baseline in FAAM (Foot and Ankle Ability and Measure) total score questionnaire on day 30
时间窗: From Baseline to Day 30
FAAM is a validated questionnaire assessing mobility and functionality on Day 30. Change = (Day 30 - Baseline Score). This instrument includes 2 subscales: 1. Activities of Daily Living (ADLs) subscale of 21 items 2. Sports subscale of 7 items. For each subscale patients were asked to answer each question with a single response that most clearly described their condition within the past week. Answers for both scales are based on a Likert scale (4-0) of: 4) "no difficulty" 3) "slight difficulty" 2) "moderate difficulty" 1) "extreme difficulty" 0) "unable to do" If an activity in question was limited by something other than their ankle, the patient was asked to record N/A To calculate the score for either subscale, the total number of points are added, divided by the total number of possible and then multiplied by 100. Therefore, a higher score reflects a higher level of physical function.
Change From Baseline in QoL (Quality of Life) total score questionnaire on day 30
时间窗: From Baseline to Day 30
QoL is a validated questionnaire assessing taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue, and general health perceptions on Day 30. Change = (Day 30 - Baseline Score). Scale scores represent the average for all items in the scale that the patients answered.
Change From Baseline in Pain on the Visual Analogue Scale (VAS scale) on day 30
时间窗: From Baseline to Day 30
Visual analogue scale (VAS) is a validated questionnaire assessing pain intensity on Day 30. Possible scores range from 0 cm (no pain) to 10 cm (Pain as bad as it could be). Change = (Day 30 - Baseline Score).
次要结局
- The number and % of patients with treatment-emergent adverse events(From Baseline to Day 30)