Trial · NCT00967499
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)
NCT00967499, Phase 2, Completed, Eisai Inc.; results first posted 2021-01-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT00967499. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00967499
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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)
- NCT number
- NCT00967499
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 239 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Postoperative Nausea and Vomiting
- Interventions
- Ondansetron, Palonosetron
- First posted
- 2009-08-28
- Last updated
- 2021-01-11
- Results first posted
- 2021-01-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Complete Control | 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. |
| Secondary | Percentage of Participants With Complete Response | 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. |
| Secondary | Percentage of Participants Who Did Not Experience Any Episode of Emesis | Up to 72 hours postdose | |
| Secondary | Percentage of Participants Who Did Not Receive Any Rescue Medication Post-surgical Procedure | Up to 72 hours postdose | |
| Secondary | Change From Baseline in Nausea Severity Score | 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. |
| Secondary | Modified Osoba Nausea and Emesis Module Questionnaire Score | 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", and 4 for the answer "very much". Raw score range from 5-20 and the total score was computed by linearly transformed the raw score to final score range as 0 to 100 by calculating (\[RS-1\]/range)\*100, with RS being the raw score and range being 3 in this case of answers scored from 1 to 4. Lower scores indicate better quality of life. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete Control | Up to 72 hours postdose | The full analysis set included all participants who were randomly assigned to and received study medication. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Response | Up to 72 hours postdose | The full analysis set included all participants who were randomly assigned to and received study medication. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Did Not Experience Any Episode of Emesis | Up to 72 hours postdose | The full analysis set included all participants who were randomly assigned to and received study medication. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Did Not Receive Any Rescue Medication Post-surgical Procedure | Up to 72 hours postdose | The full analysis set included all participants who were randomly assigned to and received study medication. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Nausea Severity Score | Baseline up to 72 hours postdose | The full analysis set included all participants who were randomly assigned to and received study medication. Here overall number of participants analyzed N signifies participants who were evaluable for this outcome measure. Here number analyzed n are the participants who were evaluable for the outcome measure at given categories. | score on a scale | MEAN |
| SECONDARY | Modified Osoba Nausea and Emesis Module Questionnaire Score | 24, 48 and 72 hours postdose | The full analysis set included all participants who were randomly assigned to and received study medication. Here overall number of participants analyzed are participants who were evaluable for this outcome measure. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Complete Control | Palonosetron | 25.0 | percentage of participants | ||
| Percentage of Participants With Complete Control | Ondansetron | 18.0 | percentage of participants | ||
| Percentage of Participants With Complete Response | Palonosetron | 31.3 | percentage of participants | ||
| Percentage of Participants With Complete Response | Ondansetron | 26.0 | percentage of participants | ||
| Percentage of Participants Who Did Not Experience Any Episode of Emesis | Palonosetron | 70.8 | percentage of participants | ||
| Percentage of Participants Who Did Not Experience Any Episode of Emesis | Ondansetron | 52.0 | percentage of participants | ||
| Percentage of Participants Who Did Not Receive Any Rescue Medication Post-surgical Procedure | Palonosetron | 37.5 | percentage of participants | ||
| Percentage of Participants Who Did Not Receive Any Rescue Medication Post-surgical Procedure | Ondansetron | 44.0 | percentage of participants | ||
| Change From Baseline in Nausea Severity Score | Palonosetron | Baseline | 5.7 | Standard Deviation 1.84 | score on a scale |
| Change From Baseline in Nausea Severity Score | Ondansetron | Baseline | 5.9 | Standard Deviation 1.86 | score on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Palonosetron | 111 | |
| Overall Study | STARTED | Ondansetron | 109 | |
| Overall Study | Treated (Full Analysis Set) | Palonosetron | 48 | |
| Overall Study | Treated (Full Analysis Set) | Ondansetron | 50 | |
| Overall Study | COMPLETED | Palonosetron | 46 | |
| Overall Study | COMPLETED | Ondansetron | 49 | |
| Overall Study | NOT COMPLETED | Palonosetron | 65 | |
| Overall Study | NOT COMPLETED | Ondansetron | 60 |
Source ClinicalTrials.gov
Adverse events148
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bradycardia | Cardiac disorders | Palonosetron | 1 | 48 | |
| other | Bradycardia | Cardiac disorders | Ondansetron | 0 | 50 | |
| other | Tachycardia | Cardiac disorders | Palonosetron | 0 | 48 | |
| other | Tachycardia | Cardiac disorders | Ondansetron | 1 | 50 | |
| other | Ventricular extrasystoles | Cardiac disorders | Palonosetron | 0 | 48 | |
| other | Ventricular extrasystoles | Cardiac disorders | Ondansetron | 1 | 50 | |
| other | Motion sickness | Ear and labyrinth disorders | Palonosetron | 1 | 48 | |
| other | Motion sickness | Ear and labyrinth disorders | Ondansetron | 0 | 50 | |
| other | Eye swelling | Eye disorders | Palonosetron | 0 | 48 | |
| other | Eye swelling | Eye disorders | Ondansetron | 1 | 50 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Palonosetron | 0 | 48 |
| Total, all-cause mortality | Ondansetron | 0 | 50 |
| Total, other adverse events | Palonosetron | 43 | 48 |
| Total, other adverse events | Ondansetron | 49 | 50 |
| Total, serious adverse events | Palonosetron | 6 | 48 |
| Total, serious adverse events | Ondansetron | 8 | 50 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25127659 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Palonosetron vs Ondansetron: deaths from any cause | Trial comparisons |
| Palonosetron vs Ondansetron: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00967499
GET https://conductscience.org/api/trials/v1/NCT00967499/events?page=2