Trial · NCT02449291

Study of APD421 as PONV Treatment (no Prior Prophylaxis)

NCT02449291, Phase 3, Completed, Acacia Pharma Ltd; results first posted 2018-12-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of APD421 as PONV Treatment (no Prior Prophylaxis). Trials, record NCT02449291. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02449291

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of APD421 as PONV Treatment (no Prior Prophylaxis)
NCT number: NCT02449291
Status: Completed
Phases: Phase 3
Enrollment: 568 participants, actual
Lead sponsor: Acacia Pharma Ltd
Conditions: Postoperative Nausea and Vomiting
Interventions: APD421, Placebo
First posted: 2015-05-20
Last updated: 2019-01-22
Results first posted: 2018-12-19
Limitations and caveats: There were no limitations or caveats associated with this study.

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Complete Response (Success of Initial PONV Treatment)	0-24 hours after treatment	The primary efficacy variable was the dichotomous variable: success or failure of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes\* to 24 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 24-hour period after administration of study medication.
Secondary	Number of Participants With Complete Response 0-2 Hrs	0-2 hours after administration of study medication	Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes to 2 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 2-hour period after administration of study medication.
Secondary	Number of Participants With Complete Response 2-24 Hrs	2-24 hours after administration of study medication	Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) and no administration of anti-emetic rescue medication from 2 to 24 hours after administration of study medication.
Secondary	Time to Treatment Failure	0-24 hours after study drug administration	Time to first violation of the criteria for complete response
Secondary	Number of Patients Experiencing Incidence of Emesis	30 mins to 24 hours after study drug administration	Number of patients experiencing vomiting or retching during the time period from 30 minutes to 24 hours after administration of study medication
Secondary	Number of Participants Using Rescue Medication	0-24 hours after study drug administration	Proportion of patients receiving pre-specified anti-emetic rescue medication at any time in the 24 hours post-treatment period
Secondary	Incidence of Significant Nausea	30 mins to 24 hours after study drug administration	Proportion of patients with nausea score ≥4 on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.
Secondary	Incidence of Nausea	30 mins to 24 hours after study drug administration	Proportion of patients with nausea score ≥1 on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.
Secondary	Maximum Severity of Nausea	30 mins to 24 hours after study drug administration	Highest recorded nausea score on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.
Secondary	Evolution Score of Nausea (0-30 Mins)	0-30 minutes after study drug administration	The evolution score of nausea was calculated as the area under the curve (AUC) of the nausea scores on a scale 0-10 (where 0 is no nausea and 10 is the worst nausea imaginable) obtained at four pre-planned time points: pre-dose (0-min), and 5, 15 and 30 minutes after administration of study medication, as well as any spontaneously reported episodes of nausea during the time period, plotted against time. A higher score represents a worse outcome.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Complete Response (Success of Initial PONV Treatment)	0-24 hours after treatment	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Complete Response 0-2 Hrs	0-2 hours after administration of study medication	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Complete Response 2-24 Hrs	2-24 hours after administration of study medication	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to Treatment Failure	0-24 hours after study drug administration	minutes	MEDIAN
SECONDARY	Number of Patients Experiencing Incidence of Emesis	30 mins to 24 hours after study drug administration	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Using Rescue Medication	0-24 hours after study drug administration	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Incidence of Significant Nausea	30 mins to 24 hours after study drug administration	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Incidence of Nausea	30 mins to 24 hours after study drug administration	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Maximum Severity of Nausea	30 mins to 24 hours after study drug administration	score on a scale	MEAN
SECONDARY	Evolution Score of Nausea (0-30 Mins)	0-30 minutes after study drug administration	Score on a scale*min	MEAN

Source ClinicalTrials.gov

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Complete Response (Success of Initial PONV Treatment)	APD421 5mg IV	60		Participants
Complete Response (Success of Initial PONV Treatment)	APD421 10mg IV	59		Participants
Complete Response (Success of Initial PONV Treatment)	Placebo	39		Participants
Number of Participants With Complete Response 0-2 Hrs	APD421 5mg	112		Participants
Number of Participants With Complete Response 0-2 Hrs	APD421 10mg	105		Participants
Number of Participants With Complete Response 0-2 Hrs	Placebo	79		Participants
Number of Participants With Complete Response 2-24 Hrs	APD421 5mg	100		Participants
Number of Participants With Complete Response 2-24 Hrs	APD421 10mg	109		Participants
Number of Participants With Complete Response 2-24 Hrs	Placebo	96		Participants
Time to Treatment Failure	APD421 5mg	159	Inter-Quartile Range 68 to NA	minutes

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	APD421 Standard	191
Overall Study	STARTED	APD421 High	188
Overall Study	STARTED	Placebo	181
Overall Study	COMPLETED	APD421 Standard	186
Overall Study	COMPLETED	APD421 High	186
Overall Study	COMPLETED	Placebo	180
Overall Study	NOT COMPLETED	APD421 Standard	5
Overall Study	NOT COMPLETED	APD421 High	2
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events60

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	Flatulence	Gastrointestinal disorders	APD421 5 mg	24	191	25
other	Flatulence	Gastrointestinal disorders	APD421 10 mg	17	188	17
other	Flatulence	Gastrointestinal disorders	Placebo	21	181	21
other	Nausea	Gastrointestinal disorders	APD421 5 mg	15	191	17
other	Nausea	Gastrointestinal disorders	APD421 10 mg	18	188	18
other	Nausea	Gastrointestinal disorders	Placebo	19	181	22
other	Constipation	Gastrointestinal disorders	APD421 5 mg	14	191	14
other	Constipation	Gastrointestinal disorders	APD421 10 mg	13	188	13
other	Constipation	Gastrointestinal disorders	Placebo	16	181	16
other	Infusion site pain	General disorders	APD421 5 mg	8	191	8

1 to 10 of 60Source ClinicalTrials.gov

See all 60 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	APD421 5 mg	0	191
Total, all-cause mortality	APD421 10 mg	0	188
Total, all-cause mortality	Placebo	0	181
Total, other adverse events	APD421 5 mg	43	191
Total, other adverse events	APD421 10 mg	45	188
Total, other adverse events	Placebo	49	181
Total, serious adverse events	APD421 5 mg	5	191
Total, serious adverse events	APD421 10 mg	4	188
Total, serious adverse events	Placebo	5	181

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31094774	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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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