JPRN-jRCTs031230350进行中（未招募）未知
Study of the influence of Diclofenac Na formulations in different dosage forms on the upper gastrointestinal mucosa in patients with low back pain
Fukase Hiroyuki0 个研究点目标入组 60 人开始时间: 2023年9月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 40age old 至 < 75age old（—）
- 性别
- All
入选标准
- •(1) Japanese patients between 40 and 75 years old at the date of consent
- •(2) The person with a clinical diagnosis of low back pain at the date of consent and who require treatment with systemic-acting NSAIDs
- •However, low back pain associated with visceral disease, fracture, trauma, infection, rheumatoid arthritis or tumor is excluded.
- •(3) The person himself / herself has received a thorough explanation of the study drug and the purpose / content of the research, voluntarily volunteered and has agreed in writing to participate in the clinical research
排除标准
- •(1) Those with gastrointestinal tract symptoms
- •(2) Those who have or have a history of gastrointestinal ulcer
- •(3) Those who have a history of gastrointestinal tract disease within 4 weeks before the start of the observation period
- •(4) Those who used the following drugs(including OTC drug) within 4 weeks before the start of the observation period
- •-Anti-ulcer drug
- •-Systemic steroids
- •-Antibacterial drug
- •However, local preparations that are not considered to affect the evaluation of upper gastrointestinal ulcer are excluded.
- •-Bisphosphonate osteoporosis drug
- •-Anticoagulant, Antiplatelet drug
- •(5) Those who have ulcers, erosions, 11 or more petechiae or active bleeding in the esophagus, stomach, pylorus and / or duodenum in upper gastrointestinal endoscopy on start date of administration of study drugs
- •(6) Those who have positive test results for H. pylori positive by the test at the beginning of the observation period
- •(7) Persons with diseases that are contraindicated in the package insert of ZICTHORU Tapes or Voltaren Tablets
- •-Patients with gastrointestinal ulcer
- •-Patients with serious blood disorders
- •-Patients with serious renal dysfunction
- •-Patients with serious hepatic dysfunction
- •-Patients with severe hypertension
- •-Patients with serious cardiac dysfunction
- •-Patients with a history of hypersensitivity to diclofenac sodium
- •-Patients with aspirin asthma (asthma attacks induced by non-steroidal anti-inflammatory and analgesic drugs) or a history of aspirin asthma
- •-Patients with encephalitis and encephalopathy during the clinical course of influenza
- •-Pregnant women or women who may be pregnant
- •-Patients receiving triamterene
- •(8) Those who are pregnant, nursing, possibly pregnant or breastfeeding
- •(9) Those who do not agree to use proper contraception during the study period
- •(10) Those who do not agree to report a pregnancy during the study and those who do not agree to attend follow-up visits of the mother and child for up to 1 month after birth
- •(11) Those who know that their skin is sensitive to external preparations (including over-the-counter drugs) and adhesive bandages
- •(12) Those who cannot secure the study drug administration site due to body hair, or those who cannot secure the planned site of administration due to skin abnormalities, tattoos or nevus or those who frequently sunburn the skin
- •(13) Participants who have participated in other clinical studies or trials within 16 weeks before the start of the study drug administration
- •(14) Other persons who are judged to be ineligible for this study by the Principal Investigator or Sub-Investigator
研究者
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