Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Helsinn Healthcare SA |
---|---|
Information provided by: | Helsinn Healthcare SA |
ClinicalTrials.gov Identifier: | NCT00828295 |
The objective of the study is to assess the safety and efficacy of two doses of IV palonosetron each administered as a single dose for the prevention of postoperative nausea and vomiting through 72 hours postoperatively in children aged 28 days up to 16 years inclusive undergoing surgical procedures requiring general endotracheal inhalation anesthesia.
Condition | Intervention | Phase |
---|---|---|
Postoperative Nausea and Vomiting |
Drug: palonosetron |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double-Blind, Randomized, Parallel Group, Stratified Study to Assess the Safety and Efficacy of Single IV Doses of Palonosetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients |
Enrollment: | 150 |
Study Start Date: | August 2008 |
Study Completion Date: | January 2009 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1 mcg/kg arm: Experimental
Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)
|
Drug: palonosetron
palonosetron IV 1 mcg/kg
|
3 mcg/kg arm: Experimental
Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
|
Drug: palonosetron
palonosetron 3mcg/kg IV
|
Ages Eligible for Study: | up to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
MAIN INCLUSION CRITERIA
Inpatient scheduled to undergo surgical procedures requiring general endotracheal anesthesia, including:
Russian Federation | |
Federal State Institution Moscow Research Institute of Pediatrics and Pediatric Surgery under the Federal Agency for High-Tech Medical Care | |
Moscow, Russian Federation | |
Federal State Institution Central Research Institute of Traumatology and Orthopedics n.a. N.N. Priorov under the Federal Agency for High-Tech Medical Care | |
Moscow, Russian Federation | |
Federal State Institution St. Petersburg Research Institute of Ear, Throat, Nose and Speech under the Federal Agency for High-Tech Medical Care | |
St. Petersburg, Russian Federation | |
State Healthcare Institution 'Regional Pediatric Clinical Hospital' | |
Yaroslavl, Russian Federation | |
State Higher Educational Institution: "St. Petersburg State Pediatric Medical Academy under the Federal Agency for Healthcare and Social Development" | |
St. Petersburg, Russian Federation | |
Ukraine | |
Ukrainian Specialized Children's Hospital "OKHMATDYT", Anesthesiology and Intensive Care Department, P.L. Shupyk National Medical Academy of Postgraduate Education, Pediatric Anesthesiology and Intensive Care Department | |
Kyiv, Ukraine | |
M.Gorkyi Donetsk National Medical University, Pediatric Surgery Department; Children's Regional Clinical Hospital | |
Donetsk, Ukraine | |
Regional Children's Hospital, ENT Department, Ivano-Frankivsk State Medical University, ENT Department | |
Ivano-Frankivsk, Ukraine | |
Children's Clinical Hospital "OKHMATDYT", Institute of Congenital Pathology under the Academy of Medical Sciences of Ukraine | |
Lviv, Ukraine | |
Regional Children's Clinical Hospital. Dnipropetrovsk State Medical Academy, Pediatric Surgery Department | |
Dnipropetrovsk, Ukraine | |
Specialized Children's Hospital "OKHMATDYT", Orthopedics and Traumatology Department, O.O. Bohomolets National Medical University, Pediatric Surgery Department | |
Kyiv, Ukraine | |
Cherkassy Regional Hospital, Pediatric Surgery Department | |
Cherkassy, Ukraine | |
Ukrainian Specialized Children's Hospital "OKHMATDYT", ENT Department, P.L. Shupyk National Medical Academy of Postgraduate Education, Pediatric ENT Department | |
Kyiv, Ukraine |
Responsible Party: | Helsinn Healthcare SA ( Maria Elisa Borroni/Study Coordinator ) |
Study ID Numbers: | PALO-07-29 |
Study First Received: | January 22, 2009 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00828295 History of Changes |
Health Authority: | United States: Food and Drug Administration; Russia: Ethics Committee; Russia: Ministry of Health and Social Development of the Russian Federation; Russia: Pharmacological Committee, Ministry of Health; Ukraine: Ministry of Health; Ukraine: State Pharmacological Center - Ministry of Health |
Postoperative Nausea and Vomiting palonosetron pediatric |
Signs and Symptoms Neurotransmitter Agents Palonosetron Postoperative Nausea and Vomiting Vomiting |
Postoperative Complications Signs and Symptoms, Digestive Nausea Serotonin |
Postoperative Nausea and Vomiting Neurotransmitter Agents Vomiting Signs and Symptoms, Digestive Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Pharmacologic Actions |
Signs and Symptoms Palonosetron Serotonin Antagonists Pathologic Processes Serotonin Agents Postoperative Complications Nausea |