Investigation of Efficacy, Safety and Pharmacokinetics with OC-108, a Novel Agent for Sclerosing Therapy of Internal Hemorrhoids-Early Phase II Study-
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Accession number;04A0542888
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| Title;Investigation of Efficacy, Safety and Pharmacokinetics with OC-108, a Novel Agent for Sclerosing Therapy of Internal Hemorrhoids-Early Phase II Study- |
| Author;
TAKAMURA HISAO
(Kenseikai, Nara Daicho Komon Byo Senta)
TAKANO MASAHIRO
(Daicho-Komonbyo Senta Takano Byoin)
OBA HIDEMI
(Rissho Koseikai Kosei Hosp.)
FUKANO MASAHIKO
(Federation of National Public Servic Personnel Mutual Aid Assoc., Inada Noborito Hospital, JPN)
IWADARE JUN'ICHI
(Social Insurance, Central General Hospital, JPN)
()
HAMANO KYOICHI
(Tokyo Women's Med. Coll.)
MIYOSHI SHINJI
(Mitsubishi Pharma Corp., JPN)
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Journal Title;Japanese Pharmacology & Therapeutics
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Journal Code:Z0947A
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ISSN:0386-3603
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VOL.32;NO.6;PAGE.355-365(2004)
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| Figure&Table&Reference;FIG.6, TBL.9, REF.10 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Sclerotherapy using OC-108 was used to treat patients with prolapsing internal hemorrhoids (Goligher's classification III and IV degrees) at four medical institutions from April 1998 to March 1999. Of a total of 16 patients, one patient was excluded from all analyses, leading to an analytical set of 15 patients (from 20 to less than 65 years old). At 28 days after injection, the improvement rate was 100%, 92% and 100% for prolapse, bleeding and the size of hemorrhoid, respectively. Of adverse reactions (subjective symptoms/objective findings), one patient (6.7%) presented with "hematuria, pollakiuria and polyuria", which probably resulted from errors in the injection procedure. The symptoms disappeared with drug treatment. Abnormal laboratory findings were seen in four patients (26.7%), but the changes were transient and returned to reference ranges or tended to be recovered to predose levels without treatment. Although aluminum that originates from the main ingredient of OC-108, i.e., aluminum potassium sulfate, transfers into blood circulation and results in a transient increase, there is no long-term continuation of the increased concentration since OC-108 therapy is completed after single doses and aluminum was excreted in urine relatively rapidly. (author abst.) |
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