Unique ID issued by UMIN | UMIN000001377 |
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Receipt number | R000001671 |
Scientific Title | Examination of large intestine contraction patterns by mosapride citrate for irritable bowel syndrome (IBS, constipation type) using a capsule endoscope |
Date of disclosure of the study information | 2008/09/17 |
Last modified on | 2011/02/10 22:56:18 |
Examination of large intestine contraction patterns by mosapride citrate for irritable bowel syndrome (IBS, constipation type) using a capsule endoscope
The change of symptom of irritable bowel syndrome is correlative with the capsule transit time.
Examination of large intestine contraction patterns by mosapride citrate for irritable bowel syndrome (IBS, constipation type) using a capsule endoscope
The change of symptom of irritable bowel syndrome is correlative with the capsule transit time.
Japan |
Irritable bowel syndrome (constipation type)
Gastroenterology |
Others
NO
Video capsule endoscopy (VCE) is a minimally invasive diagnostic test for organic disorders of the small intestine, which enables observation of the movements of all of the small intestine and part of the large intestine under physiological conditions. However, there are no reports of quantification of the image data to examine intestinal contraction patterns. We have planned clinical research to examine the effects of mosapride citrate on IBS (constipation type) using VCE image data and quantified data. In this study, the problem of VCE retention in the stomach could be mitigated by administration of mosapride citrate, which could further increase the usefulness of VCE, which will probably be widely used in the future.
Efficacy
Exploratory
Pragmatic
Symptoms of IBS
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Device,equipment |
Mosapride citrate 15 mg taken once daily in the morning after meal. Administration period is 4 to 5 weeks. Capsule endoscopy conducted before administration and after end of administration period.
20 | years-old | <= |
60 | years-old | >= |
Male and Female
Patients with irritable bowel syndrome (IBS, constipation type) in whom the lack of recognizable organic disorders has been confirmed by colonoscopy (CF), and whose blood AST (GOT) and ALT (GPT) are no more than 2 times the upper limit of the facility standard (based on Rome III criteria).
1) Patients who have taken mosapride citrate or other gastrointestinal function improving drug within 1 week before enrollment in prior treatment.
2) Patients with serious hepatic or renal impairment.
3) Patients taking a gastrointestinal function improving drug other than mosapride citrate concomitantly.
4) Patients with previous gastrointestinal surgery.
5) Patients with long-term use of nonsteroidal antiphlogistic analgetics.
6) Patients undergoing radiation therapy.
7) Patients taking calcium antagonists.
8) Patients taking iron or sucralfate preparations who cannot stop before start of the study.
9) Patients with ulcers, hemorrhage, gastrointestinal stenosis, obstruction, etc.
10) Patients with Crohn's disease.
11) Patients with an embedded electronic medical device such as a cardiac pacemaker.
12) Patients with dysphagia.
13) Patients with serious gastrointestinal diverticular disease.
14) Patients complicated by diabetes.
15) Patients with a history of allergy to mosapride citrate.
16) Patients whom the attending physician judges to be an inappropriate subject.
15
1st name | |
Middle name | |
Last name | Hidemi Goto |
Nagoya University Graduate School of Medicine
Department of Gastroenterology
65 Tsurumai-Cho, Showa-Ku, Nagoya-Shi, Aichi-Ken
1st name | |
Middle name | |
Last name | Nakamura Masanao |
Nagoya University Graduate School of Medicine
Department of Gastroenterology
65 Tsurumai-Cho, Showa-Ku, Nagoya-Shi, Aichi-Ken
052-744-2172
makamura@med.nagoya-u.ac.jp
Nagoya University Graduate School of Medicine Department of Gastroenterology
None
Self funding
NO
2008 | Year | 09 | Month | 17 | Day |
Unpublished
Completed
2008 | Year | 04 | Month | 21 | Day |
2008 | Year | 09 | Month | 01 | Day |
2011 | Year | 02 | Month | 01 | Day |
2011 | Year | 02 | Month | 01 | Day |
2008 | Year | 09 | Month | 17 | Day |
2011 | Year | 02 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001671
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