HP-3150-CR-04

JRCT ID: jRCTs031220045

Registered date:28/04/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: healthy volunteer
• Date of first enrollment: 05/06/2022
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Repeated administration of ZICTHORU Tapes or Loxoprofen Na tablets for 2 weeks.

Outcome(s)

• Primary Outcome: Rate of gastric / duodenal ulcer occurrence in upper gastrointestinal endoscopy after administration of study drug

Secondary Outcome

(1) Ulcer incidence rate for each site (stomach, duodenum)
(2) Ulcer or erosion incidence rate for each site (stomach / duodenum, stomach, duodenum)
(3) Endoscopic score (Modified Lanza score) for each site (stomach, duodenum)
(4) Number of ulcers at each site (stomach / duodenum, stomach, duodenum)
(5) Number of erosions per site (stomach / duodenum, stomach, duodenum)

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

(1) Japanese healthy adult men and women between 40 and 75 years old at the date of consent
(2) 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

Exclude criteria

(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 within 4 weeks before the start of the observation period
-NSAIDs containing study drugs (including aspirin)
-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
(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 loxonin tablets
(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 ag ree 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-counterdrugs) 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

Related Information

• Primary Sponsor: Fukase Hiroyuki
• Secondary Sponsor: Hisamitsu Pharmaceuticai Co.,Inc