JPRN-jRCT2080225195已完成3 期
A clinical pharmacological study of HP-3150 in patients with low back pain
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
Tissue (muscle or ligament) DF concentrations in the affected area (low back) were highest when the DF-Na tablet was administered (muscle) and when the HP-3150 was applied to the low back (ligament).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Japanese patients scheduled for surgery due to low back pain.
- •- Patients with a body mass index (BMI) of at least 18.5 but less than 25.0.
排除标准
- •- A patient who has received the following medications or has received the following therapies within 1 week prior to the study:
- •(1) Diclofenac formulation
- •(2) Application of topical agents to the upper arm or lumbar region
- •(3) Nerve blockers, local anesthesia, or trigger point injection to the lumbar region
- •(4) Aspirin
- •- A patient who has received drugs or cholestyramine within 4 weeks prior to the study that may have an interaction with diclofenac.
- •- A patient who has a history of surgical intervention for low back pain.
- •- A patient with concomitant rheumatoid arthritis.
- •- A patient with serious blood abnormality, liver disorder, renal disorder, hypertension, cardiac dysfunction, or other clinically problematic complications.
- •- A patient with malignancy.
- •- A patient with peptic ulcer.
- •- A patient with current or past history of aspirin-induced asthma.
- •- A patient with past history of hypersensitivity to NSAIDs.
- •- A patient who is pregnant, parturient, suspected of being pregnant, or breast-feeding.
- •- A patient who is known to have dermal sensitivity to external preparations or tapes such as adhesive tapes.
- •- A patient whose body hair does not allow patch to be secured to the application area.
- •- A patient in whom a planned site of application cannot be secured due to skin abnormality, tattoos or birthmarks, or a patient who frequently gets tanned.
研究者
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