NSAID-induced small-intestinal mucosal injury
Conditions
Interventions
1.Loxoprofen, Omeprazole and irsogladine maleate 2.washout period 3.Loxoprofen, Omeprazole and placebo
1.Loxoprofen, Omeprazole and placebo 2.washout period 3.Loxoprofen, Omeprazole and irsogladin
Sponsors
Department of Endoscopic Research and International Education (Funded by Fujifilm) in Jichi Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: H. Pylori negative volunteers aged 20 years or older, who understand the meaning and purpose of this clinical study and have consented to participate in it. They need to have a history of pain-causing conditions such as lumbago, frozen shoulder, Cervico-omo-brachial syndrome, arthalgia, myalgia, toothache, trauma, acute upper respiratory tract infection, headache and neuralgia and are considering NSAIDs use in future
Exclusion criteria
Exclusion criteria: 1) People with dysphagia. 2) People with organ dysfunction such as kidney disease, liver disease and heart disease. 3) Pregnant or possibility of pregnancy. 4) People with a history of allergic reactions to NSAIDs(nonsteroidal antiinflammatory drug) or other drugs. People with allergies. 5) People with history of asthma. 6) People with history of gastrointestinal surgeries, or who are suspicious of having a stenosis of the gastrointestinal tract. 7) People with a history of gastrointestinal hemorrhage or ulcer diseases. 8) People who are diagnosed with ulcers, apparent hemorrhagic lesions or tumors in the lower gastrointestinal tract by capsule endoscopy. 9) People with positive results of H. Pylori test. 10) People with a history of H.pylori eradication therapy. 11) People who are taking any kinds of medicines or took them within one month. Use of NSAIDs and mucosal protectant should be carefully excluded in particular. 12) People who are judged not suitable for the study by the investigator in charge or other investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of the incidence of small intestinal mucosal injury evaluated with capsule endoscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anemia (Evaluated by blood test results before and after the administration of the medicines) 2. Small bowel transit time of capsule endoscopy. 3. Subjective symptoms 4. Confirmation of adverse events | — |
Countries
Japan
Contacts
Public ContactNaoyuki Nishimura
Department of Medicine, Division of Gastroenterology, Endoscopy Center, Jichi Medical University Department of Medicine, Division of Gastroenterology
Outcome results
None listed