Gan to kagaku ryoho. Cancer & chemotherapy
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Gan To Kagaku Ryoho · Sep 1993
Multicenter Study Clinical Trial Controlled Clinical Trial[Granisetron oral phase III clinical trial--study on the inhibitory effect of granisetron for nausea/vomiting induced by chemotherapy for tumors in the hematopoietic organs].
The efficacy and safety of oral granisetron against nausea and vomiting induced by chemotherapy for tumors in the hematopoietic organs were investigated. Depending on the day of anticancer drug administration, single administration or 2 to 6-day repeated administration of granisetron at 2 mg once daily was conducted. ⋯ Adverse events which were suspected to be related to granisetron included 1 case of mild feeling of residual urine and another demonstrating very mild eosinophilia. From the above results, it was confirmed that granisetron was a safe and effective antiemetic against nausea and vomiting induced by anticancer drug administration.
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Gan To Kagaku Ryoho · Aug 1993
Multicenter Study Clinical Trial Controlled Clinical Trial[Study on the inhibitory effect of oral granisetron against nausea/vomiting induced by cytosine arabinoside containing chemotherapy for tumors in the hematopoietic organs].
We investigated the antiemetic effect, safety and usefulness of granisetron tablet on nausea/vomiting induced by cytosine arabinoside (Ara-C) in the chemotherapy for tumors in the hematopoietic organs. Out of 52 cases with malignant tumors in the hematopoietic organs including acute leukemia, 30 in granisetron group had no antiemetic treatment, were evaluated for the clinical efficacy of granisetron and 22 in control group. Their chemotherapies were combination therapy with Ara-C and daunorubicin (DNR), Ara-C and mitoxantrone (MIT), or Ara-C and etoposide (VP-16). ⋯ Granisetron was judged as "Safe" in 31 out of 32 cases (96.9%). In terms of usefulness, the drug was rated "Extremely useful" or "Useful" in 26 out of 30 cases (86.7%). The above results have shown that granisetron tablet, when administered orally once daily at a dose of 2 mg, has an excellent antiemetic effect, and is a safe and useful drug.
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Gan To Kagaku Ryoho · Jul 1993
Multicenter Study Comparative Study Clinical Trial Controlled Clinical Trial[Clinical evaluation of granisetron for nausea and vomiting induced by anticancer drugs--multi-centered placebo-controlled double-blind comparative study].
A placebo-controlled double-blind comparative trial was conducted to objectively assess the antiemetic effect on nausea and vomiting induced by anticancer drugs including cisplatin (CDDP) and safety of granisetron tablet (2 mg). In the present trial, single oral administration of the trial drug was performed one hour before the start of CDDP administration. 1) In clinical efficacy, the drug was assessed as "remarkably effective" or "effective" in 76.9% (30/39) in G group and 15.2% (7/46) in P group. ⋯ S., the dose of CDDP and the number of anticancer drugs concomitantly used with CDDP. 4) The clinical effect of single oral administration of granisetron tablet (2 mg) persisted for approximately 24 hours. 5) In terms of the safety of the trial drug, there was no adverse event or abnormal laboratory fluctuation which might pose a clinical problem. From the above results, it was concluded that single oral administration of granisetron at a dose of 2 mg could suppress nausea and vomiting induced by the administration of anticancer drugs.
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Gan To Kagaku Ryoho · Jul 1993
Multicenter Study Clinical Trial Controlled Clinical Trial[Clinical evaluation of granisetron for nausea and vomiting induced by anticancer drugs--optimal dose-finding study].
The efficacy, safety and usefulness of oral granisetron for nausea and vomiting induced by the administration of anticancer drugs were compared among four doses using the subjects registered through telephone calls by the physicians-in-charge. The clinical efficacy of the drug was assessed as "remarkably effective" or "effective" in 50.0% (11/22) in the 0.5 mg group. 68.4% (13/19) in the 1 mg group, 81.0% (17/21) in the 2 mg group and 78.3% (18/23) in the 4 mg group. ⋯ No adverse event or abnormal laboratory value fluctuation which might pose a clinical problem was observed. From these results, single administration of oral granisetron at a dose of 2 mg once a day was considered to be the optimal administration and dosage for nausea and vomiting induced by the administration of anticancer drugs.
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Gan To Kagaku Ryoho · Oct 1992
Multicenter Study Comparative Study Clinical Trial Controlled Clinical Trial[Anti-emetic effect and safety of single dose of ondansetron injection in double-blind comparison study with placebo].
In order to make an objective evaluation of anti-emetic effect, safety and usefulness of ondansetron injection in nausea and vomiting associated with cancer chemotherapy, we carried out a double-blind placebo controlled comparative study in patients receiving high-single dose (50 mg/m2 or more) of cisplatin. Either 4 mg of ondansetron or saline injection was given intravenously at 15 min. before administration of cisplatin. If anti-emetic effect of the test drug was insufficient, an additional dose of 4mg of ondansetron was given intravenously, as the rescue medication. ⋯ Furthermore, fever developed in 1 case in placebo group after the rescue medication. Elevation of total bilirubin value was observed in 2 cases in ondansetron group and 1 case in placebo group, however, these changes were mild and did not pose noteworthy clinical problem. From these results, ondansetron was shown to possess an excellent anti-emetic effect on nausea and emesis induced by highly emetogenic anti-cancer drugs, such as cisplatin, and to have no problem in safety, and thus it was considered to be a useful anti-emetic agent.