CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 216 enrolled
Drug / intervention
Comparator: MK0517 +1 moredrug
Likely dose
MK0517 40 mg IV single dose immediately prior to surgery OR ondansetron 4 mg IV single dose immediately prior to surgeryAI-extracted
Key inclusion· 4
  • ✓Open abdominal surgery requiring at least 24-hour hospital stay
  • ✓General anesthesia required
  • ✓Post-operative opioids required
  • ✓ASA physical status I, II, or III
Key exclusion· 4
  • ✕Clinically significant respiratory, metabolic, hepatic, renal, or cardiovascular dysfunction
  • ✕Congestive heart failure (CHF)
  • ✕Morbid obesity
  • ✕Mental incapacity or significant emotional/psychiatric disorder

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00231777
NCT00231777Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study Conducted Under In-House Blinding Conditions, to Examine the Safety and Tolerability of IV MK0517 for the Prevention of Postoperative Nausea and Vomiting (PONV)

Merck Sharp & Dohme LLC·interventional·Posted Oct 4, 2005·Updated Aug 19, 2015

In Brief

A Phase 3 clinical trial evaluating Comparator: MK0517 and Comparator: ondansetron for Post-Operative Nausea and Vomiting. Completed, enrolled 216 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-Operative Nausea and Vomiting
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 4, 2005
Enrollment StartJul 1, 2005
Primary CompletionNov 1, 2005
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 20.7 years ago

Interventions

Comparator: MK0517drug

a single administration of 40 mg MK0517 by IV immediately prior to surgery

Comparator: ondansetrondrug

a single administration of 4 mg ondansetron by IV immediately prior to surgery