2024-513064-26-00招募中3 期
An open label, multi-centric trial to assess the safety and efficacy of an Esflurbiprofen Topical System (EFTS) in the local symptomatic and short-term treatment of pain in contusions.
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 219
- 试验地点
- 5
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
Characterization of safety during treatment
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Period I
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •acute contusion of the upper or lower limbs
- •location of injury such that pain-on-movement (POM) is elicited on active standardized movement
- •enrolment within 6 h of the injury
- •baseline VAS score for POM of injured extremity > 50 mm on a 100 mm VAS
- •size of injury, as assessed by Investigator, ≥ 25 cm² and ≤ 120 cm²
- •adult male or female patients
- •age 18-64 years (including)
- •having given written informed consent
- •satisfactory health as determined by the Investigator based on medical history and physical examination
排除标准
- •significant concomitant injury in association with the index acute soft-tissue injury/contusion or strain; e.g. fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound
- •pregnant and lactating women
- •women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception (as defined in the clinical trial protocol)
- •known hypersensitivity to Esflurbiprofen, R-flurbiprofen or one of the excipients of the patch
- •patients with any ongoing condition that may interfere with the absorption, distribution, metabolism, or excretion of Esflurbiprofen
- •history of previous significant injury to the same area within 6 months
- •patients with a disease affecting the same area, such as synovitis, rheumatoid arthritis, arthrosis, etc.
- •patients having an ongoing painful condition associated with blunt injury/contusion
- •patients suffering from symptoms of an infectious disease including swelling of any joint close to the affected area
- •patients who had surgery of the affected area within one year of study entry
- •patients with significant diseases (defined as a disease which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient’s ability to participate in the study; includes patients with a history of gastrointestinal bleeding, significant cardiovascular, liver or renal disease)
- •excessively hairy skin at application site, cutting the hair in the injured site prior to patch application will qualify for inclusion
- •patients with a blood coagulation disorder
- •patients who use any impermissible medication
- •current skin disorder or shaving hair at application site
- •history of excessive sweating/hyperhidrosis inclusive of application site
- •intake of NSAIDs or analgesics within 36 hours, opioids within 7 days, or systemic corticosteroids within 60 days of inclusion in the study
- •intake of long-acting NSAIDs or application of topical medication since the injury
- •participation in a clinical study within 30 days before inclusion in the study or concomitantly
- •participation in this clinical study in another center
- •drug or alcohol abuse in the opinion of the Investigator
结局指标
主要结局
Adverse events (AEs)
Adverse events (AEs)
次要结局
- VAS score on POM at before bed time on Day 1, 24, 48, 72, 96, 120, 168 h and related PIDs and SPIDs
- VAS score on PAR at before bed time on Day 1, 24, 48, 72, 96, 120, 168 h and related PIDs and SPIDs
- Time to meaningful/optimal reduction of pain defined as 30 % (meaningful) and 50 % (optimal) reduction of VAS on POM
- Time to complete resolution of pain-on-movement defined as POM VAS value of 0 mm
- Time to complete resolution of pain-at-rest defined as PAR VAS value of 0 mm
- Responder rate 1 (defined as the number of patients achieving at least 50 % reduction from baseline in the VAS score for POM at 48 h)
- Responder rate 2 (defined as the number of patients able to resume training/normal physical activity by 168 h)
- Resolution of contusions (defined as the percentage of patients who showed POM=PAR=0 at 168 h)
- Global efficacy assessments by physician (GEA, 5-point scale: 0=no response; 1=poor response; 2=fair response; 3=good response; 4=excellent response) at 48, 72, and 168 h
- Global efficacy assessments by patient (GEA, 5-point scale: 0=no response; 1=poor response; 2=fair response; 3=good response; 4=excellent response) at 48, 72, and 168 h
- Use of rescue medication at every visit except Visit 1
- Local tolerability (skin damage/reaction according to an 8-point scale) at Visit 6
- Adhesive power of the EFTS will be visually assessed and classified by the site staff in a 5-point-score (0=≥ 90 % adhered / 1= ≥75 % to <90 % adhered / 2=≥50 % to <75 % adhered / 3=>0 % to <50 % adhered / 4=completely detached) at Visits 2-5 (24 h after EFTS application)
- Adhesive power of the EFTS will be visually assessed and classified by the subject in a 5-point-score (0=≥ 90 % adhered / 1= ≥75 % to <90 % adhered / 2=≥50 % to <75 % adhered / 3=>0 % to <50 % adhered / 4=completely detached) at before/after bed time and 24 h after each EFTS application
研究者
Director, Regulatory Strategy & Intelligence
Scientific
Teikoku Seiyaku Co. Ltd.
研究点 (5)
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