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A study to eveluate the safety of MR19D6A

A study to eveluate the safety of MR19D6A

19

A total of 20 subjects were enrolled in the study. All subjects were women with breast cancer, the mean age was 64.1 years, and the stage of cancer was 3 in 3 subjects (15 %) and 4 in 17 subjects (85 %).

A total of 19 subejects completed the study.

All-causality and treatment related adverse events were reported in 45.0% and 10.0% of the marketed reference product (Rozex Gel 0.75%) group and 26.3% and 5.3% of the study drug (MR19D6A) group, respectively. No serious adverse events were reported in both groups.

From comparing the safety of MR19D6A with that of Rozex Gel 0.75%, which is the main objective of this study, there was no difference in pharmacokinetics between MR19D6A and Rozex Gel 0.75% that would significantly affect the safety. In addition, there was no significant difference between the two drugs in terms of evaluation of usability and efficacy (ie, malodor of cancerous cutaneous ulcers).

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%.

June. 02, 2022

No

https://jrct.niph.go.jp/latest-detail/jRCT2031200285

Oya Nobuyo

Maruishi Pharmaceutical Co., Ltd.

2-2-18,Imazu-Naka, Turumi-ku Osaka

nobuyo_oya@maruishi-pharm.co.jp

Unit Clinical Study

Maruishi Pharmaceutical Co., Ltd.

2-2-18,Imazu-Naka, Turumi-ku Osaka

+81-6-6962-0318

kazuyo_ito@maruishi-pharm.co.jp

Complete

Jan. 15, 2021

Interventional

non-randomized controlled trial

open(masking not used)

active control

single assignment

treatment purpose

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%.

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.

Female

Cancerous cutaneous ulcers

Rozex Gel 0.75% will be applied for 7 days, then switched to MR19D6A for 7 days.

Safety: adverse events, laboratory tests (hematology, blood biochemistry), vital sign (systlic/diastolic blood pressure, pulse rate), physical findings
Pharmacokinetics: plasma concentration of metronidazole, pharmacokinetic parameters
Evaluation for usability
Evaluation for smell

+81-3-3823-2101

Nov. 13, 2020

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