JPRN-jRCT2031200285已完成1 期
A study to eveluate the safety of MR19D6A
Oya Nobuyo0 个研究点目标入组 19 人开始时间: 2021年1月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
研究概览
简要总结
The safety of Rozex Gel 0.75% (7 days) and followed by MR19D6A (7 days) was evaluated in patients with cancerous cutaneous ulcers using pharmacokinetics and adverse events as indices. There was no difference in pharmacokinetics between the two drugs that significantly affect the safety, also no trend of difference in adverse events and other safety parameters. Therefore, there was no clinically significantly difference in the safety of MR19D6A when applied to the ulcer site compered to Rozex Gel 0.75%.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •1) Japanese patients aged 20 years or older who provide informed concent for study participation.
- •2) Patients with cancerous cutaneous ulcers who expect to survival for more than one month.
- •3) Patients with an constant size of the ulcer area to be tested, up to approximately 30 g as a daily dose.
- •4) Patients on continuous use of Rozex Gel 0.75%.
排除标准
- •1) Patients who have received systemic doses of antibiotics at present and within the past two weeks.
- •2) Patients who have received metronidazole medication other than Rozex Gel 0.75% at present and within the past week.
- •3) Patients who have received topical antibiotics other than Rozex gel 0.75% to the site of a cancerous cutaneous ulcer at present and within the past week.
- •4) Patients who have received topical treatment other than Rozex gel 0.75% to the site of a cancerous cutaneous ulcer.
- •5) Patients who have a plan to change the concomitant therapy for cancer, etc.
- •6) Patients whose cutaneous ulcer to be applied the study drug is not contacted with cancerous tissues.
- •7) Patients whose cancerous cutaneous ulcer have reached the bone.
- •8) Patients with allergy or hypersensitivity to the investigational drug ingredient.
- •9) Patients using or planning to use ritonavir-containing drugs, disulfiram, coumarin anticoagulants, lithium, 5-fluorouracil, busulfan, cyclosporine, or phenobarbital.
- •10) Patients who can't abstain from alcohol.
- •11) Patients with serious cardiovascular disorders, blood disorders, or organic diseases of the brain or spinal cord.
- •12) Female patients who are pregnant, lactating, or planning to become pregnant during the study period.
- •13) Patients who participated in the intervention study at present and within the past month.
- •14) Patients with a known underlying disease or medical condition that is determined to be possible to endanger a subject, confound the evaluation of the study, or preclude a subject from participating in the study.
研究者
相似试验
进行中（未招募）
3 期
A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of ProgressionNCT05797610Hoffmann-La Roche459
已完成
1 期
Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular DegenerationAge-Related MaculopathyAge-Related MaculopathiesEye DiseasesRetinal DegenerationMacular DegenerationNCT00877032Pfizer57
已完成
1 期
A Study to Evaluate Safety, Pharmacokinetics, & Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors; Urothelial Carcinoma Substudy in Association With RO7496353 Study GO44010Pancreatic Ductal AdenocarcinomaGastric CancerGastric CancerNon-small Cell Lung CancerNon-small Cell Lung CancerNCT05867121Genentech, Inc.102
终止
1 期
Study of an Investigational Drug, RO7239361 (BMS-986089), in Ambulatory Boys With DMDMuscular Dystrophy (DMD)NCT02515669Hoffmann-La Roche43
终止
2 期
A Study to Evaluate the Safety and Tolerability of MOR106 Administered Concomitantly With Topical Corticosteroids, in Adult Participants With Moderate to Severe Atopic DermatitisAtopic DermatitisNCT03864627Galapagos NV33