Randomized, Double-blinded, Placebo-controlled Study of the Efficacy and Safety of DYV700 for Reducing Pain Associated With an Acute Gout Flare
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Pain Intensity in the Target Joint
研究概览
简要总结
This overall goal of this trial will be to demonstrate that DYV700 is safe and effective as a treatment for acute gout flares.
详细描述
Gout presents as intermittent acute painful and debilitating gout flares. High serum uric acid levels lead to the deposition of urate crystals in and around the joints, most commonly the big toe (also called podagra) and other peripheral joints. An acute gout flare causes extreme pain and inflammation of the afflicted joints. It initially presents as a monoarticular condition but can affect several joints as the disease progresses. Gout flares typically take 7-10 days to resolve.
Currently, the inflammation and pain associated with acute gout flares are treated anti-inflammatories, including non steroidal anti-inflammatory drugs (NSAIDs), colchicine, corticosteroids, and adrenocorticotropic hormone. However these drugs are limited in efficacy, contraindicated for some patients and may take more than 24 hours to relieve gout symptoms (e.g. colchicine).
DYV700 will be developed to reduce the pain associated with acute gout flares. DYV700 is applied topically and utilizes a proprietary drug delivery system to deliver it's active ingredients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Topical lotion is provided in de-identified sachets
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females and males, age 18 to 75 years of age.
- •Diagnosis of gout using ACR/EULAR criteria (must have a score of equal to or greater than 8)
- •Subjects must have experienced ≥2 gout flares in the 12 months prior to screening;
- •Subjects that have not changed their urate lowering therapy (ULT) in the 2 weeks prior to the start of the gout flare and who will remain on the same dose throughout the follow-up period of the trial.
- •If taking NSAID, oral steroids, opioids, or other pain medications at standard doses (as stated on drug label) for pain unrelated to their gout flare, must be taking the same drug for at least 7 days prior to the gout flare and throughout the length of the trial.
- •Women of childbearing potential are excluded. Women not considered of childbearing potential must have one of the following documented in their study medical history:
- •Postmenopausal for at least 12 months prior to study;
- •Without a uterus and/or both ovaries; or
- •Bilateral tubal ligation at least six months prior to study enrollment.
排除标准
- •BMI of >40kg/m2 at the time of screening
- •Subjects that have not changed their urate lowering therapy (ULT) in the 2 weeks prior to the start of the gout flare and who will remain on the same dose throughout the follow-up period of the trial.
- •Subjects who are contraindicated for the use of colchicine or whom are unable to take the SOC dose of 1.2mg followed by 0.6mg an hour later.
- •Subjects with rheumatoid arthritis, psoriatic arthritis, evidence/suspicion of infectious/septic arthritis, acute polyarticular gout (4 or more joints), with arthritis due to any cause other than gout that may confound any study assessments per Investigator discretion.
- •Subjects who have experienced >2 gout flares per month, or >12 attacks overall in the months prior to randomization.
研究组 & 干预措施
Active
DYV700, 10mL 3 times per day for 7 days Colchicine 1.2mg plus 0.6 mg 1 hour later at onset of flare (SOC)
干预措施: Colchicine 0.6 mg (Drug)
Placebo
Placebo, 10mL 3 times per day for 7 days Colchicine 1.2mg plus 0.6 mg 1 hour later at onset of flare (SOC)
干预措施: Placebo (Drug)
Active
DYV700, 10mL 3 times per day for 7 days Colchicine 1.2mg plus 0.6 mg 1 hour later at onset of flare (SOC)
干预措施: DYV700 (Drug)
Placebo
Placebo, 10mL 3 times per day for 7 days Colchicine 1.2mg plus 0.6 mg 1 hour later at onset of flare (SOC)
干预措施: Colchicine 0.6 mg (Drug)
结局指标
主要结局
Pain Intensity in the Target Joint
时间窗: Baseline-7 days
Sum of pain intensity differences (SPID) from baseline to Day 7 in the target joint, using a 11-point (0-10) numeric rating scale (NRS) pain scale with 0-No Pain and 10-The Most Intense Pain Imaginable
次要结局
- Rescue Medication Usage(Baseline-7 days)
- Swelling(24 hours and 7 days)
- PROMIS PF 20(Baseline (prior to product application and colchicine use), day 2 and day 7)
- Level of Improvement(24 hours, day 2 and day 7)
- Time to Resolution(Baseline-7 days)
- Tenderness(24 hours and 7 days)