Evaluation of Safety and Efficacy of Nasea(R)/Ramosetron Inj. in Patients Undergoing Facial Bone Fracture Operations
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ClinicalTrials.gov Identifier: NCT01637545 |
Recruitment Status
:
Terminated
(Principal Investigator is away on business)
First Posted
: July 11, 2012
Last Update Posted
: May 8, 2015
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Sponsor:
Seoul National University Hospital
Information provided by (Responsible Party):
Chan-Yeong Heo, Seoul National University Hospital
Tracking Information | ||||
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First Submitted Date ICMJE | July 8, 2012 | |||
First Posted Date ICMJE | July 11, 2012 | |||
Last Update Posted Date | May 8, 2015 | |||
Study Start Date ICMJE | December 2011 | |||
Actual Primary Completion Date | February 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
incidence and severity of nausea and vomiting [ Time Frame: for 24 h after surgery at 0-6h, 6-12 h and 12-24 h ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01637545 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
patient satisfaction with the effect [ Time Frame: at 24 h after surgery ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Evaluation of Safety and Efficacy of Nasea(R)/Ramosetron Inj. in Patients Undergoing Facial Bone Fracture Operations | |||
Official Title ICMJE | Phase 4 Study of Nasea(R)/Ramosetron Inj.as Anti-emetics in the Patients Undergoing Facial Bone Fracture Operations | |||
Brief Summary | Postoperative nausea and vomiting (PONV) is one of the most common and distressing complications after anaesthesia and surgery, and may lead to serious postoperative complications This prospective, randomized study designed to evaluate the best injection time to get the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT(3) antagonist in patients undergoing facial bone surgery. | |||
Detailed Description |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Prevention |
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Condition ICMJE | Facial Bones Fracture | |||
Intervention ICMJE | Drug: Ramosetron
G1 - Ramosetron 0.3mg i.v. just before the beginning of the surgery G2 - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room G3 - No medication but regular antiemetics injection if the patient want Other Name: Nasea® |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
49 | |||
Original Estimated Enrollment ICMJE |
99 | |||
Actual Study Completion Date | February 2015 | |||
Actual Primary Completion Date | February 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Senior | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01637545 | |||
Other Study ID Numbers ICMJE | B-1107-131-007 L-2011-329-1 ( Other Grant/Funding Number: Astellas Pharm. Co. ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Chan-Yeong Heo, Seoul National University Hospital | |||
Study Sponsor ICMJE | Seoul National University Hospital | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Seoul National University Hospital | |||
Verification Date | May 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |