임상연구정보서비스

Search: Search

Population analysis of ramosetron for postoperative nausea and vomiting

Status Approved

First Submitted Date

2014/02/05
Registered Date

2014/04/07
Last Updated Date

2017/09/13

Move list page

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0001039
Unique Protocol ID	2012-102
Public/Brief Title	Population analysis of ramosetron
Scientific Title	Population analysis of ramosetron for postoperative nausea and vomiting
Acronym	ramosetron PONV
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	HCRE 12051-6
Approval Date	2012-10-30
Institutional Review Board Name	Chonnam National University Hwasun Hospital Institutional Review Board
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Seongwook Jeong
Title	MD, PhD
Telephone	+82-61-379-8546
Affiliation	Chonnam National University Hospital Hwasun Hospital
Address	322 Seoyangro, Hwasuneup, Hwasungun
Contact Person for Public Queries
Name	Seongwook Jeong
Title	MD, PhD
Telephone	+82-61-379-8546
Affiliation	Chonnam National University Hospital Hwasun Hospital
Address	322 Seoyangro, Hwasuneup, Hwasungun
Contact Person for Updating Information
Name	Seongwook Jeong
Title	MD, PhD
Telephone	+82-61-379-8546
Affiliation	Chonnam National University Hospital Hwasun Hospital
Address	322 Seoyangro, Hwasuneup, Hwasungun

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2013-02-05 Actual
Target Number of Participant	51
Primary Completion Date	2013-12-09 , Actual
Study Completion Date	2014-03-31 , Actual
Name of Study	Chonnam National University Hospital Hwasun Hospital
Recruitment Status	Completed
Date of First Enrollment	2013-02-05 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ministry of Health & Welfare
Organization Type	Government
Project ID	A07000112311450100

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Chonnam National University Hospital Hwasun Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	We will administer the ramosetron with three dose each, 0.3, 0.45 and 0.6 mg intravemously just before the wound closure in patients for the elective operation under general anesthesia. Then sample the 5mL blood at 0, 2, 5, 10, 15, 30 minutes, 1, 2, 6, 24, 48 hours for the populational analysis of pharmacokinetics and investigate the Rhodes index for nausea vomiting and retching at 1, 6, 24, 48 hours after the ramosetron injection. We also investigate the single nucleotide polymorphism for CYP2D6, CYP1A1/2 which may contribute the ramosetron metabolism and would be a covariate in the populational pharmacokinetic and pharmacodynamic model of ramosetron.

Study Summary Information

Lay Summary

We will administer the ramosetron with three dose each, 0.3, 0.45 and 0.6 mg intravemously just before the wound closure in patients for the elective operation under general anesthesia. Then sample the 5mL blood at 0, 2, 5, 10, 15, 30 minutes, 1, 2, 6, 24, 48 hours for the populational analysis of pharmacokinetics and investigate the Rhodes index for nausea vomiting and retching at 1, 6, 24, 48 hours after the ramosetron injection. We also investigate the single nucleotide polymorphism for CYP2D6, CYP1A1/2 which may contribute the ramosetron metabolism and would be a covariate in the populational pharmacokinetic and pharmacodynamic model of ramosetron.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Prevention
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator, Caregiver
Allocation	RCT
Intervention Type	Drug
Intervention Description	ramosetron 0.3, 0.45, 0.6mg bolus intravenous injection just before surgery accoring to the group.
Number of Arms	3
Arm 1	Arm Label ramosetron 0.3
	Target Number of Participant 17
	Arm Type Active comparator
	Arm Description ramosetron 0.3mg bolus intravenous injection just before surgery
Arm 2	Arm Label ramosetron 0.45
	Target Number of Participant 17
	Arm Type Experimental
	Arm Description ramosetron 0.45mg bolus intravenous injection just before surgery
Arm 3	Arm Label ramosetron 0.6
	Target Number of Participant 17
	Arm Type Experimental
	Arm Description ramosetron 0.6mg bolus intravenous injection just before surgery

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (S00-T98)Injury, poisoning and certain other consequences of external causes (T81.8)Other complications of procedures, NEC
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~No Limit
	Description .American Society of Anesthesiology Physical status classification is 1 or 2 patients. .19 years of age or over .Surgery under elective general anesthesia. .Patients signed up the voluntary written consent to participate in clinical studies. .Apfel's Postoperative nausea and vomiting risk score is 3 or more.
Exclusion Criteria	.Under nineteen years of age .Patients with known hypersensitivity for fentanyl, ketorolac or test drug(Ramosetron). .Medications within 24 hours before surgery have potentials affecting the postoperative nausea and vomiting such as antiemetics, steroids, antihistamines,or psychotropic drugs. .American Society of Anesthesiology Physical status classification is 3 or more patients. .Patients go through nasogastric tube after surgery, .Hemoglobin is less than 10.0g/dL. .Patients participated in a screening of another clinical trial of medication within 30days. .Patients donate more than 450ml blood or blood products within 30days. .Patients with active hepatitis .Heavy aldohol drinker or clinical significant findings in patients with alcoholism .Patients with organ dysfunction or history associated with alcohol. .Besides the above all, investigators have determined that the patient is not appropriate.
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Non-compartment pharmacokinetic analysis
Timepoint	with the concentrations for the sample of 0, 2, 5, 10, 15, 30 minutes, 1, 2, 6, 24, 48 hours after drug injection
Primary Outcome(s) 2
Outcome	Populational pharmacokinetic analysis with NONMEM Ⅶ level 2
Timepoint	with the concentrations for the sample of 0, 2, 5, 10, 15, 30 minutes, 1, 2, 6, 24, 48 hours after drug injection
Primary Outcome(s) 3
Outcome	Populational pharmadynamic analysis with NONMEM Ⅶ level 2
Timepoint	with the Rhodes Index for the point of 1, 6, 24, 48 hours after the drug injection
Secondary Outcome(s) 1
Outcome	collection and reporting of all adverse events
Timepoint	During all the periods of the clinical trial

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	Yes
Final Enrollment Number
Number of Publication	1
Publications 1	Lee SH, Cho SY, Yoo KY, Jeong S. Population pharmacokinetics of ramosetron.. J Pharmacokinet Pharmacodyn. SCI. 2016-02-01 , VOL : 43 page : 73 ~ 83 https://link.springer.com/article/10.1007%2Fs10928-015-9455-8
Results Upload
Date of Posting Results	2014/04/07
Protocol URL or File Upload
Brief Summary	Ramosetron is a selective serotonergic 5-hydroxy-tryptamine receptor 3 antagonist that is used to prevent and treat postoperative nausea and vomiting. This study aimed to characterize the population pharmacokinetics of ramosetron in patients undergoing surgery with general anesthesia. Patients aged 19–80 years received a single intravenous bolus of ramosetron (0.3, 0.45, or 0.6 mg) 30 min before the end of surgery. Blood samples were collected, and plasma concentrations of ramosetron were measured by high performance liquid chromatography-tandem mass spectrometry. Pooled data from 50 patients and 479 pharmacokinetic samples were used for population pharmacokinetic analysis using the nonlinear mixed effect modeling program (NONMEM®). The pharmacokinetics of ramosetron was best described by a three-compartment mammillary model with first-order elimination. Based on allometric principles, body weight was incorporated in the base model, along with fixed allometric exponents. The typical value of clearance was 0.19 L/h in a 60-kg subject, and it decreased approximately 3 % for every year of age, starting at age of 57. The bootstrap method and visual predictive check showed that the final pharmacokinetic model was appropriate. A population pharmacokinetic model of ramosetron was constructed in adult surgical patients, providing a foundation for further defining the relationship between ramosetron dose and postoperative nausea and vomiting.

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

Move list page Move to top