Trial Outcomes & Findings for Pharmacogenomics and Post-Operative Nausea and Vomiting (NCT NCT03503292)

NCT ID: NCT03503292

Last Updated: 2020-10-28

Results Overview

The total number count of post operative nausea episodes were determined by nursing documentation or by treatment with rescue antinausea medication.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 92 participants
• Primary outcome timeframe: 0-48 hours post bariatric surgery
• Results posted on: 2020-10-28

Participant Flow

Participant milestones

Measure	CYP2D6 Rapid Metabolizer (Granisetron) Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment Granisetron: Rapid metabolizer received 1mg IV Granisetron	CYP2D6 Normal Metabolizer (Ondansetron) Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment Ondansetron: Poor or normal metabolizers received 4mg Ondansetron IV
Overall Study STARTED	2	90
Overall Study COMPLETED	2	90
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacogenomics and Post-Operative Nausea and Vomiting

Baseline characteristics by cohort

Measure	CYP2D6 Rapid Metabolizer (Granisetron) n=2 Participants Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment Granisetron: Rapid metabolizer received 1mg IV Granisetron	CYP2D6 Normal Metabolizer (Ondansetron) n=90 Participants Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment Ondansetron: Poor or normal metabolizers received 4mg Ondansetron IV	Total n=92 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 21.2 • n=5 Participants	47.1 years STANDARD_DEVIATION 13.0 • n=7 Participants	47.2 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	78 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	84 Participants n=7 Participants	86 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	90 participants n=7 Participants	92 participants n=5 Participants
Body Mass Index (BMI)	46.6 kg/m2 STANDARD_DEVIATION 15.9 • n=5 Participants	45.4 kg/m2 STANDARD_DEVIATION 9.0 • n=7 Participants	45.4 kg/m2 STANDARD_DEVIATION 9.1 • n=5 Participants

PRIMARY outcome

Timeframe: 0-48 hours post bariatric surgery

The total number count of post operative nausea episodes were determined by nursing documentation or by treatment with rescue antinausea medication.

Outcome measures

Measure	CYP2D6 Rapid Metabolizer (Granisetron) n=2 Participants Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment Granisetron: Rapid metabolizer received 1mg IV Granisetron	CYP2D6 Normal Metabolizer (Ondansetron) n=90 Participants Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment Ondansetron: Poor or normal metabolizers received 4mg Ondansetron IV
Episodes of Postoperative Nausea	0 episodes	16 episodes

PRIMARY outcome

Timeframe: 0-48 hours post bariatric surgery

The total number count of post operative vomiting episodes were determined by nursing documentation or by treatment with rescue antinausea medication.

Outcome measures

Measure	CYP2D6 Rapid Metabolizer (Granisetron) n=2 Participants Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment Granisetron: Rapid metabolizer received 1mg IV Granisetron	CYP2D6 Normal Metabolizer (Ondansetron) n=90 Participants Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment Ondansetron: Poor or normal metabolizers received 4mg Ondansetron IV
Episodes of Postoperative Vomiting	0 episodes	4 episodes

Adverse Events

CYP2D6 Rapid Metabolizer (Granisetron)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CYP2D6 Normal Metabolizer (Ondansetron)

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

Yvette N. Martin McGrew, M.D., Ph.D.

Mayo Clinic

Phone: 507-255-7481

Email: martin.yvette@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place