Trial Outcomes & Findings for A Study to Examine the Safety and Tolerability of MK0517 for the Prevention of Post-Operative Nausea and Vomiting (0517-015) (NCT NCT00231777)

Last Updated: 2015-08-19

Results Overview

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

216 participants

Primary outcome timeframe

Baseline and 24 hours

Results posted on

2015-08-19

Participant Flow

First Patient In: 02-Aug-2005; Last Patient Out: 29-Nov-2005; 15 study centers in the US

Patient is at least 18 years of age and is scheduled to undergo open abdominal surgery or vaginal hysterectomy requiring overnight hospital stay (24-hour hospital stay after end of surgery).

Participant milestones

Participant milestones
Measure	MK0517 Intravenous (IV) 40 mg On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.	Ondansetron IV 4 mg On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
Overall Study STARTED	170	46
Overall Study COMPLETED	164	44
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Reasons for withdrawal
Measure	MK0517 Intravenous (IV) 40 mg On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.	Ondansetron IV 4 mg On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
Overall Study Lost to Follow-up	3	0
Overall Study Other	3	2

Baseline Characteristics

A Study to Examine the Safety and Tolerability of MK0517 for the Prevention of Post-Operative Nausea and Vomiting (0517-015)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK0517 Intravenous (IV) 40 mg n=167 Participants On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron. Data Reported is for all all participants who received active study therapy.	Ondansetron IV 4 mg n=44 Participants On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517. The formulation of MK0517 used in this study was a non polysorbate (PS80) formulation which was not further developed and is not available for use. Data Reported is for all all participants who received active study therapy.	Total n=211 Participants Total of all reporting groups
Age, Continuous	46.4 years STANDARD_DEVIATION 11.01 • n=5 Participants	43.3 years STANDARD_DEVIATION 8.51 • n=7 Participants	45.8 years STANDARD_DEVIATION 10.59 • n=5 Participants
Sex: Female, Male Female	161 Participants n=5 Participants	42 Participants n=7 Participants	203 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 participants n=5 Participants	1 participants n=7 Participants	6 participants n=5 Participants
Race/Ethnicity, Customized Black	20 participants n=5 Participants	7 participants n=7 Participants	27 participants n=5 Participants
Race/Ethnicity, Customized Hispanic American	17 participants n=5 Participants	5 participants n=7 Participants	22 participants n=5 Participants
Race/Ethnicity, Customized Native American	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized White	124 participants n=5 Participants	31 participants n=7 Participants	155 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 24 hours

Population: All patients as treated (APaT) which included all patients who received active study therapy.

Outcome measures

Outcome measures
Measure	MK0517 Intravenous (IV) 40 mg n=167 Participants On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.	Ondansetron IV 4 mg n=44 Participants On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
Number of Patients With Clinical Adverse Experiences (CAEs)	125 Participants	32 Participants

PRIMARY outcome

Timeframe: Baseline and 24 hours

Population: All patients as treated (APaT) which included all patients who received active study therapy. patients in the MK0517 40 mg treatment group were randomized but did not have at least one post-baseline laboratory test and therefore were not counted as part of the N analyzed.

A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.

Outcome measures

Outcome measures
Measure	MK0517 Intravenous (IV) 40 mg n=165 Participants On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.	Ondansetron IV 4 mg n=44 Participants On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
Number of Patients With Laboratory Adverse Experiences (LAEs)	9 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline and 24 hours

Population: All patients as treated (APaT) which included all patients who received active study therapy.

Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs

Outcome measures

Outcome measures
Measure	MK0517 Intravenous (IV) 40 mg n=167 Participants On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.	Ondansetron IV 4 mg n=44 Participants On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
Number of Patients With Drug-related CAEs	33 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline and 24 hours

Population: All patients as treated (APaT) which included all patients who received active study therapy.

Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose

Outcome measures

Outcome measures
Measure	MK0517 Intravenous (IV) 40 mg n=167 Participants On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.	Ondansetron IV 4 mg n=44 Participants On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
Number of Patients With Serious CAEs	15 Participants	3 Participants

Adverse Events

MK0517 Intravenous (IV) 40 mg

Serious events: 15 serious events

Other events: 124 other events

Deaths: 0 deaths

Ondansetron IV 4 mg

Serious events: 3 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	MK0517 Intravenous (IV) 40 mg n=167 participants at risk On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.	Ondansetron IV 4 mg n=44 participants at risk On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
Cardiac disorders Atrial Fibrillation	0.60% 1/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	0.00% 0/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Cardiac disorders Cardiac Arrest	1.2% 2/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	0.00% 0/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Cardiac disorders Tachycardia	0.60% 1/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	0.00% 0/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Gastrointestinal disorders Constipation	0.60% 1/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	0.00% 0/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Gastrointestinal disorders Ileus	1.8% 3/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	0.00% 0/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Gastrointestinal disorders Intestinal Perforation	0.60% 1/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	0.00% 0/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Infections and infestations Abscess	0.60% 1/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	0.00% 0/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Infections and infestations Gastroenteritis	0.00% 0/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	2.3% 1/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Infections and infestations Pelvic Abscess	0.60% 1/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	0.00% 0/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Infections and infestations Pneumonia	1.8% 3/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	0.00% 0/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Infections and infestations Sepsis	0.60% 1/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	0.00% 0/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Infections and infestations Urinary Tract Infection	0.60% 1/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	0.00% 0/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Injury, poisoning and procedural complications Bladder Injury	0.00% 0/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	2.3% 1/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Injury, poisoning and procedural complications Post Procedural Complication	0.00% 0/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	2.3% 1/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Musculoskeletal and connective tissue disorders Muscle Haemorrhage	0.60% 1/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	0.00% 0/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Nervous system disorders Anoxic Encephalopathy	0.60% 1/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	0.00% 0/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Renal and urinary disorders Urinary Retention	0.60% 1/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	0.00% 0/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Reproductive system and breast disorders Pelvic Congestion	0.00% 0/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	2.3% 1/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Reproductive system and breast disorders Vaginal Haemorrhage	0.60% 1/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	0.00% 0/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Reproductive system and breast disorders Vaginal Laceration	0.60% 1/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	0.00% 0/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.60% 1/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	0.00% 0/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.60% 1/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	0.00% 0/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.60% 1/167 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.	0.00% 0/44 • 1-day plus 14 days post-therapy Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.