Trial Outcomes & Findings for Impact of CYP3A4*1G Polymorphism on Metabolism of Fentanyl in Chinese Patients Undergoing Lower Abdominal Surgery (NCT NCT01181492)

Results Overview

According to CYP3A4\*1G polymorphism,patients are devided into three groups: \*1/\*1,\*1/\*1G,\*1G/\*1G

Recruitment status

COMPLETED

Target enrollment

176 participants

Primary outcome timeframe

48 hours after operation

Results posted on

2013-11-01

Participant Flow

In Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, from November 2008 to April 2010 a total of 176 patients were recruited in this study precedure.

Participant milestones

Participant milestones
Measure	1/1 Grouped by CYP3A4\*1G polymorphism, wild-type homozygote	1/1G Grouped by CYP3A4\1G polymorphism,\1/\*1G: mutant heterozygote	1G/1G Grouped by CYP3A4\1G polymorphism,\1G/\*1G: mutant homozygote
Overall Study STARTED	103	66	7
Overall Study COMPLETED	103	66	7
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of CYP3A4*1G Polymorphism on Metabolism of Fentanyl in Chinese Patients Undergoing Lower Abdominal Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1/1 n=103 Participants Grouped by CYP3A4\*1G polymorphism, wild-type homozygote	1/1G n=66 Participants Grouped by CYP3A4\1G polymorphism,\1/\*1G: mutant heterozygote	1G/1G n=7 Participants Grouped by CYP3A4\1G polymorphism,\1G/\*1G: mutant homozygote	Total n=176 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	103 Participants n=5 Participants	66 Participants n=7 Participants	7 Participants n=5 Participants	176 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	45.5 years STANDARD_DEVIATION 11.7 • n=5 Participants	47.1 years STANDARD_DEVIATION 10.1 • n=7 Participants	42.3 years STANDARD_DEVIATION 7.8 • n=5 Participants	45.9 years STANDARD_DEVIATION 11.1 • n=4 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	34 Participants n=7 Participants	4 Participants n=5 Participants	93 Participants n=4 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	32 Participants n=7 Participants	3 Participants n=5 Participants	83 Participants n=4 Participants
Region of Enrollment China	103 participants n=5 Participants	66 participants n=7 Participants	7 participants n=5 Participants	176 participants n=4 Participants

PRIMARY outcome

Timeframe: 48 hours after operation

Population: the number of participants for analysis was determined according to gene type of CYP3A4\*1G polymorphism which was carried by participant.

According to CYP3A4\*1G polymorphism,patients are devided into three groups: \*1/\*1,\*1/\*1G,\*1G/\*1G

Outcome measures

Outcome measures
Measure	1/1 n=103 Participants Grouped by CYP3A4\*1G polymorphism, wild-type homozygote	1/1G n=66 Participants Grouped by CYP3A4\1G polymorphism,\1/\*1G: mutant heterozygote	1G/1G n=7 Participants Grouped by CYP3A4\1G polymorphism,\1G/\*1G: mutant homozygote
CYP3A4*1G Polymorphism	103 participants	66 participants	7 participants

SECONDARY outcome

Timeframe: 24 hours after operation

The visual analog scale (VAS) is used for pain evaluation at rest which from 0 to 10 (higher values represent morepain) during patient-controlled analgesia (PCA) treatment 24 h after operation

Outcome measures

Outcome measures
Measure	1/1 n=103 Participants Grouped by CYP3A4\*1G polymorphism, wild-type homozygote	1/1G n=66 Participants Grouped by CYP3A4\1G polymorphism,\1/\*1G: mutant heterozygote	1G/1G n=7 Participants Grouped by CYP3A4\1G polymorphism,\1G/\*1G: mutant homozygote
The Visual Analog Scale 24 Hours Postoperative	3.7 units on a scale Standard Deviation 1.3	3.7 units on a scale Standard Deviation 1.1	3.4 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 24 h after surgery

PCA fentanyl consumption and adverse effects are recorded during the first 24 h after surgery.

Outcome measures

Outcome measures
Measure	1/1 n=103 Participants Grouped by CYP3A4\*1G polymorphism, wild-type homozygote	1/1G n=66 Participants Grouped by CYP3A4\1G polymorphism,\1/\*1G: mutant heterozygote	1G/1G n=7 Participants Grouped by CYP3A4\1G polymorphism,\1G/\*1G: mutant homozygote
PCA Fentanyl Consumption	395.0 μg Standard Deviation 138.5	359.8 μg Standard Deviation 120.2	247.1 μg Standard Deviation 73.2

Adverse Events

1/1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

1/1G

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

1G/1G

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zhang Xianwei

Huazhong University of Science&Technology

Phone: 027 83662853

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Trial Outcomes & Findings for Impact of CYP3A4*1G Polymorphism on Metabolism of Fentanyl in Chinese Patients Undergoing Lower Abdominal Surgery (NCT NCT01181492)

Results Overview

Participant Flow

Participant milestones

Reasons for withdrawal

Baseline Characteristics

Baseline characteristics by cohort

PRIMARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

Adverse Events

*1/*1

*1/*1G

*1G/*1G

Serious adverse events

Other adverse events

Additional Information

Zhang Xianwei

Results disclosure agreements

1/1

1/1G

1G/1G