Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00090

2 Trial Registration Date

2005-11-16

i Registration Status

Prospective

3 Secondary IDs

None

4 Source(s) of Funding

Departmental

5 Primary Sponsor

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

6 Secondary Sponsor

None

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Matthew Chan

ii Address

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

iii Phone

26322736

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Matthew Chan

ii Address

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

iii Phone

26322736

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Single dose Aprepitant to Prevent Postoperative Nausea and Vomiting

10 Public Title

NA

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

NA

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2005-11-01

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Postoperative nausea and vomiting

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Aprepitant

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Preoperative single dose

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

All women undergoing open gynecologic surgery will be eligible if they: (1) are aged between 18 and 60 years; (2) are American Society of Anesthesiologists physical status 1-2;

ii Exclusion Criteria

Exclusion criteria: (1) Patients had preexisting nausea or vomiting (2) Patients had received opioids or drugs with known antiemetic properties in the 24 hours before surgery. (3) Pregnant patients.

iii Age Minimum

18

iv Age Maximum

60

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2005-12-01

21 Target Sample Size

320

22 Recruitment Status

Unknown

23 Primary Outcome

Complete treatment response (i.e. no vomiting, no nausea and no need for rescue antiemetics)

24 Secondary Outcome

Patient satisfaction and quality of reciovery

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-11-25

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000671

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NA

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Trial History Detail on 2011-04-01