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临床试验/jRCT2080225195
jRCT2080225195已完成3 期

A clinical pharmacological study of HP-3150 in patients with low back pain

Hisamitsu Pharmaceutical Co., Inc.1 个研究点目标入组 32 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
32
试验地点
1
主要终点
-

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
干预模型
Multicenter, open-label, active-controlled, randomized, parallel-group comparison
主要目的
Other

入排标准

年龄范围
20age old over 至 No limit(—)
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.

结局指标

主要结局

-

pharmacokinetics - Drug concentration in tissue and plasma

次要结局

  • safety

研究者

研究点 (1)

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