Trial Outcomes & Findings for 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 NCT00967499)

Last Updated: 2021-01-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

239 participants

Primary outcome timeframe

Up to 72 hours postdose

Results posted on

2021-01-11

Participant Flow

Participants took part in the study at 8 investigative sites in the United States from 13 July 2009 to 18 December 2009. PONV is postoperative nausea and vomiting and PACU is postanesthesia care unit.

A total of 239 participants were enrolled and screened, of which 19 participants were screen failures and 220 participants were randomized out of which only 98 participants received the treatment. 122 randomized participants were not treated as they did not experience PONV within 6 hours of PACU admission.

Participant milestones

Participant milestones
Measure	Palonosetron Participants received a single dose of palonosetron 0.075 milligram (mg), intravenously, over a period of 10 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.	Ondansetron Participants received a single dose of ondansetron 4 mg, intravenously, over a period of 30 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.
Overall Study STARTED	111	109
Overall Study Treated (Full Analysis Set)	48	50
Overall Study COMPLETED	46	49
Overall Study NOT COMPLETED	65	60

Reasons for withdrawal

Reasons for withdrawal
Measure	Palonosetron Participants received a single dose of palonosetron 0.075 milligram (mg), intravenously, over a period of 10 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.	Ondansetron Participants received a single dose of ondansetron 4 mg, intravenously, over a period of 30 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.
Overall Study Adverse Event	0	1
Overall Study Protocol Violation	1	0
Overall Study Sponsor Decision	1	0
Overall Study Randomized but not treated	63	59

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Palonosetron n=48 Participants Participants received a single dose of palonosetron 0.075 mg, intravenously, over a period of 10 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.	Ondansetron n=50 Participants Participants received a single dose of ondansetron 4 mg, intravenously, over a period of 30 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.	Total n=98 Participants Total of all reporting groups
Age, Continuous	41.0 years STANDARD_DEVIATION 10.22 • n=5 Participants	42.5 years STANDARD_DEVIATION 13.80 • n=7 Participants	41.8 years STANDARD_DEVIATION 12.14 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	50 Participants n=7 Participants	98 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	45 Participants n=7 Participants	83 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 72 hours postdose

Population: The full analysis set included all participants who were randomly assigned to and received study medication.

Outcome measures

Outcome measures
Measure	Palonosetron n=48 Participants Participants received a single dose of palonosetron 0.075 mg, intravenously, over a period of 10 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.	Ondansetron n=50 Participants Participants received a single dose of ondansetron 4 mg, intravenously, over a period of 30 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.
Percentage of Participants With Complete Control	25.0 percentage of participants	18.0 percentage of participants

SECONDARY outcome

Timeframe: Up to 72 hours postdose

Population: The full analysis set included all participants who were randomly assigned to and received study medication.

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.

Outcome measures

Outcome measures
Measure	Palonosetron n=48 Participants Participants received a single dose of palonosetron 0.075 mg, intravenously, over a period of 10 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.	Ondansetron n=50 Participants Participants received a single dose of ondansetron 4 mg, intravenously, over a period of 30 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.
Percentage of Participants With Complete Response	31.3 percentage of participants	26.0 percentage of participants

SECONDARY outcome

Timeframe: Up to 72 hours postdose

Population: The full analysis set included all participants who were randomly assigned to and received study medication.

Outcome measures

Outcome measures
Measure	Palonosetron n=48 Participants Participants received a single dose of palonosetron 0.075 mg, intravenously, over a period of 10 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.	Ondansetron n=50 Participants Participants received a single dose of ondansetron 4 mg, intravenously, over a period of 30 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.
Percentage of Participants Who Did Not Experience Any Episode of Emesis	70.8 percentage of participants	52.0 percentage of participants

SECONDARY outcome

Timeframe: Up to 72 hours postdose

Population: The full analysis set included all participants who were randomly assigned to and received study medication.

Outcome measures

Outcome measures
Measure	Palonosetron n=48 Participants Participants received a single dose of palonosetron 0.075 mg, intravenously, over a period of 10 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.	Ondansetron n=50 Participants Participants received a single dose of ondansetron 4 mg, intravenously, over a period of 30 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.
Percentage of Participants Who Did Not Receive Any Rescue Medication Post-surgical Procedure	37.5 percentage of participants	44.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to 72 hours postdose

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Palonosetron n=47 Participants Participants received a single dose of palonosetron 0.075 mg, intravenously, over a period of 10 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.	Ondansetron n=48 Participants Participants received a single dose of ondansetron 4 mg, intravenously, over a period of 30 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.
Change From Baseline in Nausea Severity Score Baseline	5.7 score on a scale Standard Deviation 1.84	5.9 score on a scale Standard Deviation 1.86
Change From Baseline in Nausea Severity Score Change at 72 hours postdose	-5.1 score on a scale Standard Deviation 2.36	-5.6 score on a scale Standard Deviation 2.25

SECONDARY outcome

Timeframe: 24, 48 and 72 hours postdose

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Palonosetron n=47 Participants Participants received a single dose of palonosetron 0.075 mg, intravenously, over a period of 10 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.	Ondansetron n=47 Participants Participants received a single dose of ondansetron 4 mg, intravenously, over a period of 30 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.
Modified Osoba Nausea and Emesis Module Questionnaire Score 24 Hours Postdose	11.3 score on a scale Standard Deviation 27.38	12.1 score on a scale Standard Deviation 23.94
Modified Osoba Nausea and Emesis Module Questionnaire Score 48 Hours Postdose	6.5 score on a scale Standard Deviation 19.29	7.0 score on a scale Standard Deviation 18.44
Modified Osoba Nausea and Emesis Module Questionnaire Score 72 Hours Postdose	6.7 score on a scale Standard Deviation 17.80	6.2 score on a scale Standard Deviation 15.25

Adverse Events

Palonosetron

Serious events: 6 serious events

Other events: 43 other events

Deaths: 0 deaths

Ondansetron

Serious events: 8 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Palonosetron n=48 participants at risk Participants received a single dose of palonosetron 0.075 mg, intravenously, over a period of 10 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.	Ondansetron n=50 participants at risk Participants received a single dose of ondansetron 4 mg, intravenously, over a period of 30 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV.
Cardiac disorders Extrasystoles	0.00% 0/48 • 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	2.0% 1/50 • 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
Cardiac disorders Myocardial infarction	0.00% 0/48 • 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	2.0% 1/50 • 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
Gastrointestinal disorders Gastrointestinal disorder	2.1% 1/48 • 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	0.00% 0/50 • 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
Gastrointestinal disorders Vomiting	2.1% 1/48 • 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	0.00% 0/50 • 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
Gastrointestinal disorders Ileus	0.00% 0/48 • 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	2.0% 1/50 • 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
Gastrointestinal disorders Nausea	0.00% 0/48 • 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	2.0% 1/50 • 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
Infections and infestations Cellulitis	0.00% 0/48 • 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	2.0% 1/50 • 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
Injury, poisoning and procedural complications Procedural pain	6.2% 3/48 • 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	4.0% 2/50 • 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
Injury, poisoning and procedural complications Operative haemorrhage	2.1% 1/48 • 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	0.00% 0/50 • 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
Injury, poisoning and procedural complications Anaemia postoperative	0.00% 0/48 • 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	2.0% 1/50 • 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
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	2.1% 1/48 • 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	0.00% 0/50 • 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
Renal and urinary disorders Urinary retention	0.00% 0/48 • 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	2.0% 1/50 • 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
Surgical and medical procedures Pain management	0.00% 0/48 • 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	2.0% 1/50 • 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
Vascular disorders Thrombophlebitis	0.00% 0/48 • 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	2.0% 1/50 • 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

Other adverse events

Additional Information

Eisai Medical Services

Eisai, Inc.

Phone: 1-888-422-4743

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place