Unique ID issued by UMIN | UMIN000021555 |
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Receipt number | R000024834 |
Scientific Title | Safety and efficacy of polyphosphate for the treatment of ulcerative colitis(AMU002-CR01) |
Date of disclosure of the study information | 2016/03/31 |
Last modified on | 2018/09/25 08:41:18 |
Safety and efficacy of polyphosphate for the treatment of ulcerative colitis(AMU002-CR01)
Safety and efficacy of polyphosphate for the treatment of ulcerative colitis(AMU002-CR01)
Safety and efficacy of polyphosphate for the treatment of ulcerative colitis(AMU002-CR01)
Safety and efficacy of polyphosphate for the treatment of ulcerative colitis(AMU002-CR01)
Japan |
Ulcerative colitis
Gastroenterology | Gastrointestinal surgery |
Others
NO
To assess the safety and efficacy of polyphosphate in the treatment of ulcerative colitis
Safety,Efficacy
Frequency and grade of adverse events due to 4-week administration of polyphosphate for the treatment of ulcerative colitis
Efficacy of 4-week administration of polyphosphate for improvements in clinical and histological inflammation and the expressions of pro-inflammatory cytokines in the treatment of ulcerative colitis
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Oral administration of polyphosphate
Step 1 300mg/day of polyphosphate, after meal in the mornig everyday for 28 days
Step 2 1000mg/day of polyphosphate, after meal in the morning everyday for 28 days
16 | years-old | <= |
Not applicable |
Male and Female
Patients with refractory ulcerative colitis (Mayo score, 3 to 8; rectal bleeding score, 1 or more; endoscopic subscore, 2 or more)
Patients with drug allergies, renal failure, liver dysfunction, malignancies, pregnancy, history of bowel surgery, infectious colitis, irritable bowel disease, hyperthyroidism or hyperphosphatemia
Patients who are judged to be ineligible by the chief study conductor or doctor in charge
10
1st name | |
Middle name | |
Last name | Mikihiro Fujiya |
Asahikawa Medical University
Division of Gastroenterology and Hematology/Oncology, Department of Medicine
2-1-1-1, Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
81-166-68-2462
fjym@asahikawa-med.ac.jp
1st name | |
Middle name | |
Last name | Mikihiro Fujiya |
Asahikawa Medical University
Division of Gastroenterology and Hematology/Oncology, Department of Medicine
2-1-1-1, Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
81-166-68-2462
fjym@asahikawa-med.ac.jp
Asahikawa Medical University
None
Self funding
NO
2016 | Year | 03 | Month | 31 | Day |
Unpublished
Completed
2016 | Year | 03 | Month | 14 | Day |
2016 | Year | 04 | Month | 20 | Day |
2016 | Year | 03 | Month | 22 | Day |
2018 | Year | 09 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024834
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