Unique ID issued by UMIN | UMIN000005577 |
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Receipt number | R000006598 |
Scientific Title | An Open-Label Trial of Vesicare(Solifenacin Succinate) for the Treatment of Diarrhea Predominant Irritable Bowel Syndrome (IBS-D) |
Date of disclosure of the study information | 2011/05/09 |
Last modified on | 2012/03/21 14:13:03 |
An Open-Label Trial of Vesicare(Solifenacin Succinate) for the Treatment of Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
Effect of Vesicare on IBS-D
An Open-Label Trial of Vesicare(Solifenacin Succinate) for the Treatment of Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
Effect of Vesicare on IBS-D
Japan |
Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
Gastroenterology |
Others
NO
6-week, open-label trial of Vesicare in subjects with IBS-D.
Efficacy
Exploratory
Not applicable
IBS symptoms of week 6 and IBS symptoms at week 0 (before the start of Vesicare)
IBS symptoms for the last week
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Maneuver |
One 5 mg Vesicare tablet taken orally per day for 2 weeks. If IBS symptoms for the last week improve, continue the dose for additional 4 weeks. If not, two 5mg tablets are taken for addtional 4 weeks. IBS symstoms of the week 6 and those of the week -1 are compared.
20 | years-old | <= |
Not applicable |
Male and Female
Subjects must have been diagnosed with IBS-D by a physician (Rome III Criteria).
Subject must be outpatients and be over 20 years of age.
Uncontrolled heart disease or arrhythmias.
History of major gastrointestinal surgery.
Urinary retention.
Narrow angle glaucoma.
myasthenia gravis.
Severe constipation.
20
1st name | |
Middle name | |
Last name | Yasushi Fukushima |
Tokyo-Eki Center-building Clinic
Department of Internal Medicine
3-14, Nihonbashi 3-chome, Chuo-ku, Tokyo, 103-0027 JAPAN
03-3517-6688
1st name | |
Middle name | |
Last name | Yasushi Fukushima |
Tokyo-Eki Center-building Clinic
Department of Internal Medicine
3-14, Nihonbashi 3-chome, Chuo-ku, Tokyo, 103-0027 JAPAN
03-3517-6688
Yasushi.fukushima.c@tec-c.jp
Tokyo-Eki Center-building Clinic
Tokyo-Eki Center-building Clinic
Self funding
NO
医療法人社団旭和会 東京駅センタービルクリニック(東京都)
2011 | Year | 05 | Month | 09 | Day |
Unpublished
Completed
2010 | Year | 11 | Month | 29 | Day |
2011 | Year | 02 | Month | 01 | Day |
2011 | Year | 05 | Month | 01 | Day |
2011 | Year | 07 | Month | 01 | Day |
2011 | Year | 10 | Month | 01 | Day |
2012 | Year | 01 | Month | 01 | Day |
2011 | Year | 05 | Month | 09 | Day |
2012 | Year | 03 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006598
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