Phase 3
N=216
A Study to Examine the Safety and Tolerability of MK0517 for the Prevention of Post-Operative Nausea and Vomiting (0517-015)
Post-Operative Nausea and Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT00231777 ↗Enrolled (actual)
216
Serious AEs
8.5%
Results posted
Jun 2010
Primary outcome: Primary: Number of Patients With Clinical Adverse Experiences (CAEs) — 125; 32 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Comparator: MK0517 (Drug); Comparator: ondansetron (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Nov 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Clinical Adverse Experiences (CAEs) |
125; 32 | — |
| PRIMARY Number of Patients With Laboratory Adverse Experiences (LAEs) |
9; 2 | — |
| SECONDARY Number of Patients With Drug-related CAEs |
33; 8 | — |
| SECONDARY Number of Patients With Serious CAEs |
15; 3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00231777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.