2024-513063-45-00招募中3 期
Randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety of an Esflurbiprofen Topical System (EFTS) vs. placebo in the local symptomatic and short-term treatment of pain in ankle sprains.
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 5
- 主要终点
- Sum of Pain Intensity Difference (SPID), of 100-mm- Visual Analogue Scale (VAS) score on pain-on-movement (POM) over 0-48 hours
研究概览
简要总结
To demonstrate that the EFTS is superior in pain reduction compared to a matching placebo in patients with acute ankle sprains based on Sum of Pain Intensity Difference (SPID) of Visual Analogue Scale (VAS) score on pain-on-movement (POM) over 0-48 hours.
研究设计
- 分配方式
- Randomized
- 主要目的
- Period I
- 盲法
- Double (Subject, Analyst, Investigator, Carer, Monitor)
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 ankle sprains Grade I
- •location of injury such that pain-on-movement (POM) is elicited on active standardized movement
- •enrollment within 6 hours of the injury
- •baseline VAS score for POM of injured extremity > 50 mm on a 100 mm VAS
- •adult male or female patients
- •age 18 to 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 soft- tissue injury/contusion or strain; e.g. fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound
- •patients who had surgery of the affected lower limb 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 (except inhaled corticosteroids for e.g. topical treatment of bronchial asthma) within 60 days of inclusion in the study
- •intake of long-acting NSAIDs or application of topical medication since the injury (RICE allowed)
- •participation in a clinical study within 30 days before inclusion in the study or concomitantly
- •pregnant and lactating women
- •participation in this clinical study in another center
- •drug or alcohol abuse in the opinion of the Investigator
- •known allergy to paracetamol and galenic components of the rescue medication
- •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 extremity within 6 months
- •patients with a disease affecting the same limb, 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 of the affected lower limbs
结局指标
主要结局
Sum of Pain Intensity Difference (SPID), of 100-mm- Visual Analogue Scale (VAS) score on pain-on-movement (POM) over 0-48 hours
Sum of Pain Intensity Difference (SPID), of 100-mm- Visual Analogue Scale (VAS) score on pain-on-movement (POM) over 0-48 hours
次要结局
- VAS score on POM at 6 h, before bed time on Day 1, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 h and related PIDs and SPIDs
- VAS score on PAR at 6 h, before bed time on Day 1, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 h and related PIDs and SPIDs
- Time to meaningful/optimal reduction of pain defined as first at least 30% (meaningful) and 50% (optimal) reduction from baseline 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 hours)
- Responder rate 2 (defined as the number of patients able to resume training / normal physical activity by 168 hours)
- Resolution of ankle sprain (defined as the percentage of patients who showed POM=PAR=0 at 168 hours)
- 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 hours
- 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 hours
- Use of rescue medication at every visit except Visit 1
- AEs and SAEs
- 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 Visit 2-5 (24 hours 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 hours after each EFTS application
研究者
Director, Regulatory Strategy & Intelligence
Scientific
Teikoku Seiyaku Co. Ltd.
研究点 (5)
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