Prevention of NSAIDs-Induced Small Intestinal Mucosal Injury

JRCT ID: jRCTs051240184

Registered date:14/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adult males
• Date of first enrollment: 14/11/2024
• Target sample size: 16
• Study type: Interventional
• Intervention(s): To investigate the preventive effect of APAP on NSAID-induced gastrointestinal mucosal injury (especially in the small intestine) in healthy adult males. This study will be conducted at the Gastrointestinal Endoscopy Center on the 4th floor of Building A, Osaka Medical and Pharmaceutical University Hospital. Study subjects will be asked to visit the Endoscopy Center at the time of each visit. The blood samples will be collected from the recruited subjects and the stool sample collection container will be given to the subjects. If the subjects are found to be eligible, we will contact them by e-mail and ask them to come back to the hospital after fasting and collecting stool samples (Visit 2). In case of non-compliance, the subject will be contacted by e-mail and informed that no further examination will be performed and the stool collection container will be collected. Small intestine capsule endoscopy, upper gastrointestinal endoscopy, and the Izumo Scale will be described to confirm subjective symptoms at that time (Test 1) at Visit 2. The schedule for the day of the examination is described below. Subjects will be given a 2-week supply of oral medication to be taken in Medication Period I. Group A will take one 60 mg tablet of the study drug, loxoprofen sodium, three times a day for 2 weeks, and Group B will take one 300 mg tablet of acetaminophen three times a day for 2 weeks in addition to one 60 mg tablet of loxoprofen sodium three times a day. The oral medication schedule is given to the subjects so that they can record that they have taken the medication, and the schedule is collected at the time of the examination after the oral medication period is completed to check the oral medication status.Visit 3 is at the end of the study medication (2 weeks after Visit 2), and subjects are examined in the same fasting state as in Visit 2 (Test 2). Thereafter, a washout period of 2 to 6 weeks is set. Group A will be asked to return to the clinic (Visit 4) and take 1 loxoprofen sodium 60 mg tablet and 1 acetaminophen 300 mg tablet 3 times a day for 2 weeks, and Group B will be asked to take 1 loxoprofen sodium 60 mg tablet 3 times a day for 2 weeks, followed by Visit 5 (2 weeks after Visit 4). After 2 weeks from Visit 4), the same tests as in Visit 3 will be performed (Test 3).

Outcome(s)

• Primary Outcome: Number of small intestinal mucosal injuries

Secondary Outcome

1) Percentage of mucosal injury in the small intestine (frequency of occurrence)
2) Mucosal injury in upper gastrointestinal endoscopy
3) Changes in fecal calprotectin
4) Changes in abdominal symptoms according to the Izumo scale
5) Hemoglobin, transaminase, and creatinine levels
6) Influence of the presence or absence of H. pylori infection on the decrease in the number of mucosal injuries in the upper gastrointestinal tract

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Male

Include criteria

The study will focus on healthy adults. Recruitment will be open to the general public healthy volunteers who meet all of the following criteria will be included.
Japanese healthy adult males between the ages of 20 and 64 on the date consent is obtained.
The individual has received a full explanation of the drugs to be used in the study and the purpose and content of the study, has voluntarily volunteered to participate in the study, and has given his/her written consent to participate in the study.

Exclude criteria

Persons with gastrointestinal symptoms
Persons with peptic ulcer, gastrointestinal bleeding, or a history of peptic ulcer or gastrointestinal bleeding
Persons with a history of Crohn's disease, intestinal obstruction, or other gastrointestinal diseases
Persons with findings or history of suspected colorectal or small intestinal stenosis
Persons who have taken any of the following medications within 2 weeks of the start of the observation period
NSAIDs (including aspirin), including research drugs
Gastric mucous membrane protective drugs (including gastric acid secretion inhibitors) Antibacterial drugs Systemic steroids
Persons with underlying medical conditions requiring continuous medication
Persons with a history of hypersensitivity to NSAIDs or acetaminophen
Persons with a history of aspirin asthma
Have a cardiac pacemaker or other electro medical device implanted in the heart
Other subjects deemed inappropriate for this study by the Principal Investigator.

Related Information

• Primary Sponsor: Nishikawa Hiroki
• Source(s) of Monetary Support: Lion Corporation