Unique ID issued by UMIN | UMIN000008967 |
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Receipt number | R000010481 |
Scientific Title | Efficacy of zinc-carnosine chelate compound, Polaprezinc, enemas in patients with ulcerative colitis |
Date of disclosure of the study information | 2012/09/24 |
Last modified on | 2012/09/24 01:29:02 |
Efficacy of zinc-carnosine chelate compound, Polaprezinc, enemas in patients with ulcerative colitis
Efficacy of Polaprezinc enema in UC
Efficacy of zinc-carnosine chelate compound, Polaprezinc, enemas in patients with ulcerative colitis
Efficacy of Polaprezinc enema in UC
Japan |
Ulcerative Colitis
Gastroenterology |
Others
NO
The purpose of this study was to evaluate the efficacy of Polaprezinc enemas for moderate to severe UC patients.
Efficacy
Confirmatory
Pragmatic
Not applicable
The primary end point was a clinical response at week 1.
Secondary end points were a mucosal healing and a pathological response at week 1.
Interventional
Parallel
Randomized
Individual
Single blind -investigator(s) and assessor(s) are blinded
Placebo
NO
NO
Institution is considered as a block.
NO
Numbered container method
2
Treatment
Medicine |
Polaprezinc group: Polaprezinc enema contained 150 mg of Polaprezinc suspension in tap water (total volume 100 mL) daily for one week
Placebo group: 100 mL tap water enema daily for one week
18 | years-old | <= |
Not applicable |
Male and Female
Moderate to severe active ulcerative colitis patients who undergo usual induction therapy with a mesalazine, a corticosteroid, and intravenous hyperalimentation.
Key exclusion criteria:
(1) Patients who attend to another clinical trial
(2) Patients who is disqualified by physician's assessment
(3) Patients who have serious complications
(4) Patients who have allergic reaction to Polaprezinc
30
1st name | |
Middle name | |
Last name | Masayuki Saruta |
The Jikei University School of Medicine
Division of Gastroenterology and Hepatology
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
03-3433-1111
1st name | |
Middle name | |
Last name | Masayuki Saruta |
The Jikei University School of Medicine
Division of Gastroenterology and Hepatology
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
03-3433-1111
The Jikei University School of Medicine
Division of Gastroenterology and Hepatology
self funding
Self funding
NO
東京慈恵会医科大学(東京都)
2012 | Year | 09 | Month | 24 | Day |
Partially published
Completed
2008 | Year | 10 | Month | 01 | Day |
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2012 | Year | 09 | Month | 23 | Day |
2012 | Year | 09 | Month | 24 | Day |
2012 | Year | 09 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010481
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