Evaluation of Safety and Efficacy of Nasea(R)/Ramosetron Inj. in Patients Undergoing Facial Bone Fracture Operations

This study has been terminated.

(Principal Investigator is away on business)

Sponsor:

Information provided by (Responsible Party):

Chan-Yeong Heo, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01637545

First received: July 8, 2012

Last updated: May 7, 2015

Last verified: May 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

July 8, 2012

Last Updated Date

May 7, 2015

Start Date ^ICMJE

December 2011

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

Participants
- 100 patients with undergoing facial bone surgery are going to be randomly allocated to one of the 3 groups
Randomization
- G1(n=33) - Ramosetron 0.3mg i.v. just before the beginning of the surgery
- G2(n=33) - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room
- G3(n=33) - No medication but regular antiemetics i.v. if the patient wants
The primary endpoint
- the incidence of nausea and vomiting for 24 h after surgery at 0-6h, 6-12 h and 12-24 h
The secondary endpoints
- the severity of nausea, need for rescue medication
- patient satisfaction with efficacy

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Prevention

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®

Study Arms

Active Comparator: Preop. ramosetron 0.3mg i.v.
G1 - Ramosetron 0.3mg i.v. just before the beginning of the surgery

Intervention: Drug: Ramosetron
Active Comparator: Postop. ramosetron 0.3mg i.v.
G2 - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room

Intervention: Drug: Ramosetron
Active Comparator: No Ramosetron
G3 - No medication but regular antiemetics injection if the patient wants

Intervention: Drug: Ramosetron

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

February 2015

Primary Completion Date

February 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient who sign informed consent form for the study
patient who are considered as surgical candidates with facial bones fracture

Exclusion Criteria:

Patient who have had nausea/vomiting episodes

Sex/Gender

Sexes Eligible for Study:

All

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

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. )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Chan-Yeong Heo, Seoul National University Hospital

Study Sponsor ^ICMJE

Seoul National University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Chanyeong Heo, Ph.D.

Seoul National University Bundang Hospital

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

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