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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000008967 |
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Date of registration:
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24/09/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of zinc-carnosine chelate compound, Polaprezinc, enemas in patients with ulcerative colitis
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Scientific title:
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Efficacy of zinc-carnosine chelate compound, Polaprezinc, enemas in patients with ulcerative colitis - Efficacy of Polaprezinc enema in UC |
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Date of first enrolment:
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2009/01/01 |
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Target sample size:
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30 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010481 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not applicable
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Countries of recruitment
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Japan
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Contacts
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Name:
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Masayuki Saruta |
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Address:
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3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
Japan |
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Telephone:
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03-3433-1111 |
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Email:
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Affiliation:
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The Jikei University School of Medicine Division of Gastroenterology and Hepatology |
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Name:
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Masayuki Saruta |
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Address:
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3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
Japan |
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Telephone:
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03-3433-1111 |
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Email:
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Affiliation:
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The Jikei University School of Medicine Division of Gastroenterology and Hepatology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 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
Age minimum:
18years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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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
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Primary Outcome(s)
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The primary end point was a clinical response at week 1.
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Secondary Outcome(s)
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Secondary end points were a mucosal healing and a pathological response at week 1.
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Source(s) of Monetary Support
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self funding
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/01/2012 |
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URL:
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