Pilot Study to Assess Palonosetron Versus Ondansetron as Rescue Medication in Subjects That Develop Postoperative Nausea and Vomiting (PONV) in the Postanesthesia Care Unit (PACU)
CompletedPhase 2Results postedLast updated 11 January 2021
What this trial tests
Phase 2 trial testing Ondansetron in Postoperative Nausea and Vomiting in 239 participants. Completed in 18 December 2009.
18 and older, any sex, with Postoperative Nausea and Vomiting. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Complete ControlPrimary· Up to 72 hours postdose
Complete control was defined as participants with no emetic episode, no rescue medication, and no more than 3 on the nausea numeric rating scale (NRS) severity score. The 11-point NRS scale (ranging from 0-10), where 0 means no nausea, 2 or 3 was mild nausea, around 5 was moderate nausea, 7 and higher was severe nausea and 10 means the worst possible nausea. Higher scores were considered as worse outcome.
Group
Value
95% CI
Palonosetron
25.0
Ondansetron
18.0
Percentage of Participants With Complete ResponseSecondary· Up to 72 hours postdose
Complete response was defined as participants with no emetic episode and no use of rescue medication. An emetic episodic is defined as any number of retches (unproductive emesis) in a single 5-minute period; 1 or a sequence of vomits in a close succession not relieved by a period of relaxation of at least 2 minutes; or retching of less than (\<) 5 minutes duration combined with a single vomit.
Group
Value
95% CI
Palonosetron
31.3
Ondansetron
26.0
Percentage of Participants Who Did Not Experience Any Episode of EmesisSecondary· Up to 72 hours postdose
Group
Value
95% CI
Palonosetron
70.8
Ondansetron
52.0
Percentage of Participants Who Did Not Receive Any Rescue Medication Post-surgical ProcedureSecondary· Up to 72 hours postdose
Group
Value
95% CI
Palonosetron
37.5
Ondansetron
44.0
Change From Baseline in Nausea Severity ScoreSecondary· Baseline up to 72 hours postdose
Severity of nausea was assessed at specific time points using an 11-point NRS scale (ranging from 0-10) for evaluation of nausea severity. On the 0-10 rating scale, 0 means no nausea, 2 or 3 was mild nausea, around 5 was moderate nausea, 7 and higher was severe nausea and 10 means the worst possible nausea. Higher scores were considered as worse outcome.
Baseline
Group
Value
95% CI
Palonosetron
5.7
± 1.84
Ondansetron
5.9
± 1.86
Change at 72 hours postdose
Group
Value
95% CI
Palonosetron
-5.1
± 2.36
Ondansetron
-5.6
± 2.25
Modified Osoba Nausea and Emesis Module Questionnaire ScoreSecondary· 24, 48 and 72 hours postdose
Modified Osoba nausea and emesis module questionnaire was used to assess the impact of nausea and emesis on functional interference at 24, 48 and 72 hours postdose. The modified Osoba questionnaire included specific questions regarding the interference of nausea and emesis in daily activities (appetite, sleep, physical activities, social life, and enjoyment of life) with respective choices. The raw score of the modified Osoba questionnaire was the arithmetic mean of the non-missing item scores, using 1 for the answer "not at all", 2 for the answer "a little", 3 for the answer "quite a bit", an
24 Hours Postdose
Group
Value
95% CI
Palonosetron
11.3
± 27.38
Ondansetron
12.1
± 23.94
48 Hours Postdose
Group
Value
95% CI
Palonosetron
6.5
± 19.29
Ondansetron
7.0
± 18.44
72 Hours Postdose
Group
Value
95% CI
Palonosetron
6.7
± 17.80
Ondansetron
6.2
± 15.25
Adverse events — posted to ClinicalTrials.gov
Time frame: From on or after date of first dose of study drug up to and including 30 days after last dose of study drug, or up to approximately 158 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Palonosetron
Serious: 6/48 (13%)
Deaths: 0/48
Ondansetron
Serious: 8/50 (16%)
Deaths: 0/50
Serious adverse events (14 terms)
Reaction
System
Palonosetron
Ondansetron
Procedural pain
Injury, poisoning and procedural complications
—
—
Extrasystoles
Cardiac disorders
—
—
Myocardial infarction
Cardiac disorders
—
—
Gastrointestinal disorder
Gastrointestinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Ileus
Gastrointestinal disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Cellulitis
Infections and infestations
—
—
Operative haemorrhage
Injury, poisoning and procedural complications
—
—
Anaemia postoperative
Injury, poisoning and procedural complications
—
—
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to investigate palonosetron versus ondansetron as rescue medication in subjects that develop postoperative nausea and vomiting (PONV) in the Postanaesthesia Care Unit (PACU).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT06861010 — Evaluating the Safety and Efficacy of Ondansetron in the Prevention of Post Endoscopic Retrograde Cholangiopancreatograp
· Phase 3
· recruiting
NCT07310563 — A Trial to Evaluate Interactions Between Antiemetic Medication and AMG 133 in Participants Living With Overweight or Obe
· Phase 1
· completed
NCT06898268 — Efficacy and Safety of Ondansetron Versus Metaclopromide Treatment in Infants With Gastro Oesophageal Reflux
· NA
· completed
NCT06475846 — A Trial of HRS5580 in Prevention of Postoperative Nausea and Vomiting of Adults
· Phase 2
· completed
NCT06390787 — The Efficacy of B6 and Metoclopramide Combination in Comparison With the Other Antiemetics
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· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eisai Inc.
Last refreshed: 11 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00967499.