KCT0007704已完成未知
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate Analgesic Efficacy and Safety of Opiranserin Cream for Myofascial pain syndrome
Vivozon Healthcare0 个研究点目标入组 90 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1. Men and women who are 19 to 70 years of age diagnosed with myofascial pain syndrome (including muscle tension, VDT, and turtle neck syndrome)
- •2. Female subjects who are not pregnant or breastfeeding.
- •3. Subjects who report the pain intensity 4 = on the NRS and moderate = on the VRS when pressing (without excessive stimulation of the trriger point) or moving the pain area
- •4. Subjects must have the ability to provide written informed consent.
- •5. Subjects who agree to collect the patient diary.
排除标准
- •1. Women who are pregnant or breastfeeding.
- •2. Women with the possibility of pregnancy (premenopausal women except those who are in a medical condition that is not acquired or inherently impregnable) or are not planning to use medically acceptable contraceptives (e.g., oral contraceptives, intrauterine contraceptives, condoms, or diaphragms) during the study
- •3. Subject with muscle inflammation or muscle necrosis
- •4. Subjects with neurological that can cause pain or inflammatory conditions (such as sciatica, arthritis, neuromyopathy, fibromyalgia, sprain, etc.)
- •5. Subjects with surgical history at the pain site.
- •6. Subjects with a skin disease at the pain site.
- •7. Subjects with an unstable medical condition (e.g., unstable angina, congestive heart failure, renal failure, hepatic failure, or acquired immunodeficiency syndrome) or poorly controlled psychiatric conditions (e.g., post-traumatic stress disorder, anxiety, or depression).
- •8. History of alcohol, opiate, or other drug abuse or dependence within 12 months before the Screening Visit.
- •9. Subjects who use opioids or antipsychotics on screening visit and/or within 24 hours of treatment.
- •10. Subjects who use nonsteroidal anti-inflammatory drugs (NSAIDs), muscle relaxants, pain relief patches on the screening visit and/or within 24 hours of treatment.
- •11. Subjects with non-drug treatment (Physical therapy, laser therapy, acupuncture, moxibustion, massage, etc.) on screening visit and/or within 24 hours of treatment.
- •12. Subjects with alcohol consumption on screening visit and/or within 24 hours of treatment.
- •13. Subjects who received another investigational drug within 30 days prior to screening visit
- •14. Subjects who were determined to be unsuitable for this study by Investigator's judgment.
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