Post-Operative Nausea and Vomiting
Conditions
Brief summary
A new intravenous medication is being tested for the prevention of the nausea and vomiting that occurs after surgery. This new medication is being compared to another intravenous medication that is already available to patients for this indication.
Interventions
DRUGComparator: MK0517
a single administration of 40 mg MK0517 by IV immediately prior to surgery
a single administration of 4 mg ondansetron by IV immediately prior to surgery
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Open abdominal surgery requiring 24 hour hospital stay * General anesthesia * Post-operative opioids * ASA status of I-III
Exclusion criteria
* Patient exhibits evidence of any clinically significant respiratory, metabolic, hepatic, renal dysfunction, or cardiovascular condition or congestive heart failure (CHF) * Morbid obesity * Patient is mentally incapacitated or has a significant emotional or psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Clinical Adverse Experiences (CAEs) | Baseline and 24 hours | 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 |
| Number of Patients With Laboratory Adverse Experiences (LAEs) | Baseline and 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Drug-related CAEs | Baseline and 24 hours | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs |
| Number of Patients With Serious CAEs | Baseline and 24 hours | 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 |
Participant flow
Recruitment details
First Patient In: 02-Aug-2005; Last Patient Out: 29-Nov-2005; 15 study centers in the US
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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.
Data Reported is for all all participants who received active study therapy. | 167 |
| 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.
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. | 44 |
| Total | 211 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Other | 3 | 2 |
Baseline characteristics
| Characteristic | Ondansetron IV 4 mg | Total | MK0517 Intravenous (IV) 40 mg |
|---|---|---|---|
| Age, Continuous | 43.3 years STANDARD_DEVIATION 8.51 | 45.8 years STANDARD_DEVIATION 10.59 | 46.4 years STANDARD_DEVIATION 11.01 |
| Race/Ethnicity, Customized Asian | 1 participants | 6 participants | 5 participants |
| Race/Ethnicity, Customized Black | 7 participants | 27 participants | 20 participants |
| Race/Ethnicity, Customized Hispanic American | 5 participants | 22 participants | 17 participants |
| Race/Ethnicity, Customized Native American | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 31 participants | 155 participants | 124 participants |
| Sex: Female, Male Female | 42 Participants | 203 Participants | 161 Participants |
| Sex: Female, Male Male | 2 Participants | 8 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 124 / 167 | 31 / 44 |
| serious Total, serious adverse events | 15 / 167 | 3 / 44 |
Outcome results
Primary
Number of Patients With Clinical Adverse Experiences (CAEs)
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
Time frame: Baseline and 24 hours
Population: All patients as treated (APaT) which included all patients who received active study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK0517 Intravenous (IV) 40 mg | Number of Patients With Clinical Adverse Experiences (CAEs) | 125 Participants |
| Ondansetron IV 4 mg | Number of Patients With Clinical Adverse Experiences (CAEs) | 32 Participants |
Primary
Number of Patients With Laboratory Adverse Experiences (LAEs)
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK0517 Intravenous (IV) 40 mg | Number of Patients With Laboratory Adverse Experiences (LAEs) | 9 Participants |
| Ondansetron IV 4 mg | Number of Patients With Laboratory Adverse Experiences (LAEs) | 2 Participants |
Secondary
Number of Patients With Drug-related CAEs
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Time frame: Baseline and 24 hours
Population: All patients as treated (APaT) which included all patients who received active study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK0517 Intravenous (IV) 40 mg | Number of Patients With Drug-related CAEs | 33 Participants |
| Ondansetron IV 4 mg | Number of Patients With Drug-related CAEs | 8 Participants |
Secondary
Number of Patients With Serious CAEs
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
Time frame: Baseline and 24 hours
Population: All patients as treated (APaT) which included all patients who received active study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK0517 Intravenous (IV) 40 mg | Number of Patients With Serious CAEs | 15 Participants |
| Ondansetron IV 4 mg | Number of Patients With Serious CAEs | 3 Participants |