Trial · NCT02646566
Study of APD421 as PONV Treatment (Prior Prophylaxis)
NCT02646566, Phase 3, Completed, Acacia Pharma Ltd; results first posted 2018-12-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of APD421 as PONV Treatment (Prior Prophylaxis). Trials, record NCT02646566. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02646566
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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 (Prior Prophylaxis)
- NCT number
- NCT02646566
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 705 participants, actual
- Lead sponsor
- Acacia Pharma Ltd
- Conditions
- Postoperative Nausea and Vomiting
- Interventions
- APD421, Placebo
- First posted
- 2016-01-05
- Last updated
- 2019-01-22
- Results first posted
- 2018-12-19
- Limitations and caveats
- There were no limitations or caveats with this study
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Complete Response (Success of Initial PONV Treatment) | 0-24 hours after administration of study medication | 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 0-4 Hrs | 0-4 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 4 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 4-hour period after administration of study medication. |
| Secondary | Number of Participants With Complete Response 0-6 Hrs | 0-6 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 6 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 6-hour period 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 With 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 Patients Receiving Rescue Medication | 0-24 hours after study drug administration | Number of patients receiving pre-specified anti-emetic rescue medication at any time in the 24 hours post-treatment period |
| Secondary | Number of Patients With an Incidence of Significant Nausea | 30 mins to 24 hours after study drug administration | Number 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 | Number of Patients With an Incidence of Nausea | 30 mins to 24 hours after drug administration | Number 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Complete Response (Success of Initial PONV Treatment) | 0-24 hours after administration of study medication | Modified ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete Response 0-2 Hrs | 0-2 hours after administration of study medication | Modified ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete Response 0-4 Hrs | 0-4 hours after administration of study medication | Modified ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete Response 0-6 Hrs | 0-6 hours after administration of study medication | Modified ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Treatment Failure | 0-24 hours after study drug administration | Modified ITT population | minutes | MEDIAN |
| SECONDARY | Number of Patients With Incidence of Emesis | 30 mins to 24 hours after study drug administration | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Receiving Rescue Medication | 0-24 hours after study drug administration | Modified ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With an Incidence of Significant Nausea | 30 mins to 24 hours after study drug administration | Modified ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With an Incidence of Nausea | 30 mins to 24 hours after drug administration | Modified ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Severity of Nausea | 30 mins to 24 hours after study drug administration | Modified ITT population | Score on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Complete Response (Success of Initial PONV Treatment) | APD421 5mg | 80 | Participants | ||
| Number of Participants With Complete Response (Success of Initial PONV Treatment) | APD421 10mg | 96 | Participants | ||
| Number of Participants With Complete Response (Success of Initial PONV Treatment) | Placebo | 67 | Participants | ||
| Number of Participants With Complete Response 0-2 Hrs | APD421 5mg | 134 | Participants | ||
| Number of Participants With Complete Response 0-2 Hrs | APD421 10mg | 160 | Participants | ||
| Number of Participants With Complete Response 0-2 Hrs | Placebo | 116 | Participants | ||
| Number of Participants With Complete Response 0-4 Hrs | APD421 5mg | 105 | Participants | ||
| Number of Participants With Complete Response 0-4 Hrs | APD421 10mg | 136 | Participants | ||
| Number of Participants With Complete Response 0-4 Hrs | Placebo | 87 | Participants | ||
| Number of Participants With Complete Response 0-6 Hrs | APD421 5mg | 99 | Participants |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | APD421 5mg | 237 | |
| Overall Study | STARTED | APD421 10mg | 230 | |
| Overall Study | STARTED | Placebo | 235 | |
| Overall Study | COMPLETED | APD421 5mg | 231 | |
| Overall Study | COMPLETED | APD421 10mg | 226 | |
| Overall Study | COMPLETED | Placebo | 230 | |
| Overall Study | NOT COMPLETED | APD421 5mg | 6 | |
| Overall Study | NOT COMPLETED | APD421 10mg | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events72
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 | Nausea | Gastrointestinal disorders | APD421 IV 5mg | 30 | 237 | 33 |
| other | Nausea | Gastrointestinal disorders | APD421 IV 10mg | 27 | 230 | 28 |
| other | Nausea | Gastrointestinal disorders | Placebo | 30 | 235 | 32 |
| other | Flatulence | Gastrointestinal disorders | APD421 IV 5mg | 13 | 237 | 13 |
| other | Flatulence | Gastrointestinal disorders | APD421 IV 10mg | 13 | 230 | 13 |
| other | Flatulence | Gastrointestinal disorders | Placebo | 18 | 235 | 18 |
| other | Constipation | Gastrointestinal disorders | APD421 IV 5mg | 13 | 237 | 13 |
| other | Constipation | Gastrointestinal disorders | APD421 IV 10mg | 11 | 230 | 11 |
| other | Constipation | Gastrointestinal disorders | Placebo | 17 | 235 | 17 |
| other | Vomiting | Gastrointestinal disorders | APD421 IV 5mg | 11 | 237 | 14 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | APD421 IV 5mg | 0 | 237 |
| Total, all-cause mortality | APD421 IV 10mg | 0 | 230 |
| Total, all-cause mortality | Placebo | 0 | 235 |
| Total, other adverse events | APD421 IV 5mg | 64 | 237 |
| Total, other adverse events | APD421 IV 10mg | 66 | 230 |
| Total, other adverse events | Placebo | 78 | 235 |
| Total, serious adverse events | APD421 IV 5mg | 6 | 237 |
| Total, serious adverse events | APD421 IV 10mg | 3 | 230 |
| Total, serious adverse events | Placebo | 5 | 235 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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/NCT02646566
GET https://conductscience.org/api/trials/v1/NCT02646566/results?page=2