Unique ID issued by UMIN | UMIN000002498 |
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Receipt number | R000003062 |
Scientific Title | Investigation of incidence of loxoprofen-induced small-intestinal mucosal injury and inhibitory effect of irsogladine maleate on its induction using capsule endoscopy |
Date of disclosure of the study information | 2009/09/15 |
Last modified on | 2010/05/25 15:55:46 |
Investigation of incidence of loxoprofen-induced small-intestinal mucosal injury and inhibitory effect of irsogladine maleate on its induction using capsule endoscopy
Investigation of mucosal protective agents for small intestinal mucosal injury.
Investigation of incidence of loxoprofen-induced small-intestinal mucosal injury and inhibitory effect of irsogladine maleate on its induction using capsule endoscopy
Investigation of mucosal protective agents for small intestinal mucosal injury.
Japan |
NSAID-induced small-intestinal mucosal injury
Gastroenterology |
Others
NO
To evaluate the rate of the incidence of small intestinal mucosal injury induced by loxoprofen and to investigate the inhibitory effect of irsogladine maleate on its induction using capsule endoscopy
Pharmacodynamics
Exploratory
The rate of the incidence of small intestinal mucosal injury evaluated with capsule endoscopy.
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
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
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 irsogladine maleate
20 | years-old | <= |
Not applicable |
Male and Female
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
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.
19
1st name | |
Middle name | |
Last name | Hironori Yamamoto |
Department of Medicine, Division of Gastroenterology, Endoscopy Center, Jichi Medical University
Department of Endoscopic Research and International Education (Funded by Fujifilm)
3311-1 Yakushiji Shimotsuke-shi, Tochigi-ken 329-0498
0285-58-7539
1st name | |
Middle name | |
Last name | Naoyuki Nishimura |
Department of Medicine, Division of Gastroenterology, Endoscopy Center, Jichi Medical University
Department of Medicine, Division of Gastroenterology
3311-1 Yakushiji Shimotsuke-shi, Tochigi-ken 329-0498
0285-58-7539
naoyukin@jichi.ac.jp
Department of Endoscopic Research and International Education (Funded by Fujifilm)
in Jichi Medical University
None
Self funding
NO
2009 | Year | 09 | Month | 15 | Day |
Unpublished
Completed
2009 | Year | 08 | Month | 10 | Day |
2009 | Year | 09 | Month | 01 | Day |
2011 | Year | 06 | Month | 01 | Day |
2009 | Year | 09 | Month | 15 | Day |
2010 | Year | 05 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003062
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