NEWS HIGHLIGHTS
Published Studies Related to Kytril Injection (Granisetron)
Randomized, double-blind, crossover study of palonosetron compared with granisetron for the prevention of chemotherapy-induced nausea and vomiting in a Chinese population. [2011.03]
The objective of this study was to compare the efficacy and tolerability of palonosetron and granisetron in a Chinese population receiving highly emetogenic cisplatin-based chemotherapy or moderately emetogenic chemotherapy. Patients were stratified by chemotherapy with cisplatin (yes/no) and then randomly assigned to receive either palonosetron (0.25 mg i.v.) in the first cycle followed by granisetron (3 mg i.v.) in the second cycle or vice versa...
Efficacy and tolerability of transdermal granisetron for the control of
chemotherapy-induced nausea and vomiting associated with moderately and highly
emetogenic multi-day chemotherapy: a randomized, double-blind, phase III study. [2011]
the control of chemotherapy-induced nausea and vomiting (CINV)... CONCLUSIONS: The GTDS provides effective, well-tolerated control of CINV
Dexamethasone with either granisetron or ondansetron for postoperative nausea and vomiting in laparoscopic surgery. [2010.02]
In a prospective randomized double-blind study, we compared the effectiveness of dexamethasone 8 mg with either granisetron 1 mg or ondansetron 4 mg in the prevention of postoperative nausea and vomiting in patients undergoing laparoscopic surgery. Hundred ASA I and II patients scheduled for laparoscopic surgery were enrolled in the study and 84 patients completed it...
Reduction of severity of pruritus after elective caesarean section under spinal anaesthesia with subarachnoid morphine: a randomised comparison of prophylactic granisetron and ondansetron. [2010.01]
BACKGROUND: The incidence of pruritus after elective caesarean section under spinal anaesthesia with subarachnoid morphine may be 60-100%, and is a common cause of maternal dissatisfaction. Ondansetron has been shown to reduce pruritus but the effect is short-lived. The objective of this randomized double-blind trial was to evaluate the anti-pruritic efficacy of granisetron compared with ondansetron... CONCLUSIONS: Administration of granisetron 3mg i.v. reduces the severity of pruritus and the use of rescue anti-pruritic medication, and improves satisfaction but does not reduce the overall incidence of pruritus in women who have received subarachnoid morphine 150 microg compared to ondansetron 8 mg i.v. Copyright 2009 Elsevier Ltd. All rights reserved.
Enhanced tolerability of the 5-hydroxytryptophane challenge test combined with granisetron. [2010.01]
A recently developed oral serotonergic challenge test consisting of 5-Hydroxytryptophane (5-HTP, 200 mg) combined with carbidopa (CBD, 100 mg + 50 mg) exhibited dose-related neuroendocrine responsiveness and predictable pharmacokinetics. However, its applicability is limited by nausea and vomiting...
Clinical Trials Related to Kytril Injection (Granisetron)
A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy [Active, not recruiting]
This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of
Kytril in preventing PONV in children. Patients will be randomized to receive a single dose
of either 20 micrograms or 40 micrograms Kytril iv 15 minutes prior to the end of surgery
with general anesthesia for tonsillectomy or adenotonsillectomy. The anticipated time on
study treatment is <3 months, and the target sample size is 100-500 individuals.
Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years [Not yet recruiting]
Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years [Not yet recruiting]
Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years [Recruiting]
Phase 4 Trial to Evaluate the Efficacy and Safety of Sancuso Patch in CINV (Chemotherapy-induced Nausea and Vomiting) Associated With the Administration of MEC (Moderately Emetogenic Chemotherapy) [Recruiting]
Multicenter, randomized, open-label, paralled-group, active-controlled study. The study is
to demonstrate non-inferiority of the Granisetron Transdermal Delivery System (GTDS)
compared with the intravenous and oral Granisetron in the prevention of CINV associated with
moderately emetogenic Chemotherapy.
Patients scheduled to receive the one cycle of a ME chemotherapy regimen administered for
1-4 days will attend a Screening Visit 2 to 28 days before start of ME chemotherapy.
Eligible patients will be randomized to 1 of 2 treatment groups at the Randomization Visit
(1 to 2 days prior to ME chemotherapy).
- Sancuso patch
- Kytril inj.+Kytril tab.
The patch will be applied 2days (48-24h) prior to first daily dose of the moderately
emetogenic chemotherapy regimen and remain in place for 6 days. The patient will be assessed
daily until 4days after first chemotherapy administration. Adverse Events (AEs) will be
collected until 14 days after the final dose of IP. Non-serious AEs will be followed-up
until 14 days after the final dose of IP. Serious adverse events will be followed-up until
they are resolved, stable or until the patient is lost to follow-up.
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