HP-3150-CR-06

JRCT ID: jRCTs031230350

Registered date:20/09/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Low back pain
• Date of first enrollment: 18/10/2023
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Repeated administration of ZICTHORU Tapes or Diclofenac Na tablets for 2 weeks

Outcome(s)

• Primary Outcome: Incidence of gastroduodenal ulcer and / or erosion in upper gastrointestinal endoscopy after administration of study drug

Secondary Outcome

1) Incidence of gastric / duodenal ulcer and / or erosion
2) Incidence of gastroduodenal, gastric / duodenal ulcer
3) Number of gastroduodenal, gastric / duodenal ulcer
4) Number of gastroduodenal, gastric / duodenal erosion

Key inclusion & exclusion criteria

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

Include criteria

(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

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(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

Related Information

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