PONVPhase 3NCT01991860

US Phase III Study of APD421 in PONV

A Phase 3 study testing APD421- Amisulpride for IV injection in people with PONV, run by Acacia Pharma Ltd at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: PONV
What is being tested?: APD421- Amisulpride for IV injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 364 participants
Where: 1 siteUnited States
Study dates: Aug 2013to Jan 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patients ≥ 18 years of age
Patients undergoing elective surgery (open or laparoscopic technique) under general anaesthesia, expected to last at least one hour from induction of anaesthesia to wound closure and expected to require at least one overnight stay in hospital

Who cannot join

Patients scheduled for outpatient/day case surgery
Patients scheduled to undergo intra-thoracic, transplant or central nervous system surgery
Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal or epidural) block
Patients who are expected to remain ventilated for a period after surgery
Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke
Durham, North Carolina

Other trials in United States

About this study

Official title: Randomized, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting

A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.

Conditions: PONV
Being tested: APD421- Amisulpride for IV injection, Placebo
Medical subject headings: Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

APD421- Amisulpride for IV injectionDrug
Also called Amisulpride for IV injection
APD421 ( Amisulpride) at 5mg given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia
PlaceboDrug
Matching Placebo given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia

Study groups in NCT01991860
Study group	Role	What they receive
APD421	Experimental	APD421 (amisulpride), at 5mg given by single intravenous (IV) administration by slow push over one minute at induction of anaesthesia. Receives: Drug: APD421- Amisulpride for IV injection
Placebo	Placebo comparator	Matching placebo given by single IV administration by slow push over one minute at induction of anaesthesia Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Complete Response
The primary efficacy analysis was a comparison of the incidence of Complete Response, defined as no emesis (vomiting or retching) and no use of rescue medication in the 24 hours after the end of surgery, between the active group and the placebo group using Pearson χ2 test with Yates's continuity correction, and with a two-sided significance level of 5%.
Measured: 24 hours after the end of surgery

Secondary outcomes (6)

Number of Participants With no Nausea.
Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "No nausea" means no score ≥ 1.
Measured: 24 hours after end of surgery
Number of Participants With no Emesis
Emesis is defined as vomiting (production of even the smallest amount of stomach contents) or retching (muscular movements of vomiting but without expulsion of stomach contents, usually because of an empty stomach)
Measured: 24 hours after end of surgery
Number of Participants With no Use of Rescue Medication
Any agent given in the post-operative period with the intention of providing anti-emetic rescue was counted as rescue anti-emetic medication for the purposes of efficacy determination, even if it did not achieve control of emesis or was given incorrectly (e.g., wrong dosage or route). Any agent given in the post-operative period which would be expected, by virtue of its pharmacology, dosage and route, to exert a clinically meaningful anti-emetic effect was considered as rescue anti-emetic medication, even if administered inadvertently or without the intention of providing rescue.
Measured: 24 hours after end of surgery
The Number of Participants With no Emesis, no Significant Nausea and no Use of Rescue Medication
No occurrence of vomiting/retching, no nausea score ≥ 4 on verbal response scale (where 0=no nausea at all and 10=the worst nausea imaginable) and no use of rescue medication.
Measured: 24 hours after the end of surgery
The Number of Participants With no Significant Nausea
Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "No significant nausea" means no score ≥ 4.
Measured: 24 hours after the end of surgery
Number of Participants With "Total Response"
Total response is defined as no occurrence of vomiting/retching, no nausea score ≥ 1 and no use of rescue medication.
Measured: 24 hours after the end of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Jan 2014

First posted25 Nov 2013 (estimated)
Study startAug 2013
Primary completionJan 2014
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PONVStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 364 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01991860
Sponsor's protocol ID: DP10015
Status last verified: Jan 2019
First submitted: 11 Nov 2013
Last updated: 12 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
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Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
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Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Not yet recruitingPhase 4
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
Postoperative Vomiting, Postoperative Nausea and Vomiting

All PONV trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting
ClinicalTrials.gov ID: NCT01991860
Acronym / sponsor ID: DP10015
Conditions: PONV
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 364 participants (actual)
Lead sponsor: Acacia Pharma LtdIndustry (pharma, biotech, devices)
Study start: Aug 2013
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 25 Nov 2013 (estimated)
Results: Posted 6 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
APD421	Experimental	Drug: APD421- Amisulpride for IV injectionAPD421 (amisulpride), at 5mg given by single intravenous (IV) administration by slow push over one minute at induction of anaesthesia.
Placebo	Placebo comparator	Drug: PlaceboMatching placebo given by single IV administration by slow push over one minute at induction of anaesthesia

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male or female patients ≥ 18 years of age
Patients undergoing elective surgery (open or laparoscopic technique) under general anaesthesia, expected to last at least one hour from induction of anaesthesia to wound closure and expected to require at least one overnight stay in hospital

Key exclusion criteria (5 listed)

Patients scheduled for outpatient/day case surgery
Patients scheduled to undergo intra-thoracic, transplant or central nervous system surgery
Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal or epidural) block
Patients who are expected to remain ventilated for a period after surgery
Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
APD421- Amisulpride for IV injectionAlso: Amisulpride for IV injectionAPD421 ( Amisulpride) at 5mg given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia	Drug	APD421
PlaceboMatching Placebo given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia	Drug	Placebo

Primary outcome

Number of Participants With Complete Response
Time frame: 24 hours after the end of surgery
The primary efficacy analysis was a comparison of the incidence of Complete Response, defined as no emesis (vomiting or retching) and no use of rescue medication in the 24 hours after the end of surgery, between the active group and the placebo group using Pearson χ2 test with Yates's continuity correction, and with a two-sided significance level of 5%.

6 secondary outcomes

Number of Participants With no Nausea.
Time frame: 24 hours after end of surgery
Number of Participants With no Emesis
Time frame: 24 hours after end of surgery
Number of Participants With no Use of Rescue Medication
Time frame: 24 hours after end of surgery
The Number of Participants With no Emesis, no Significant Nausea and no Use of Rescue Medication
Time frame: 24 hours after the end of surgery
The Number of Participants With no Significant Nausea
Time frame: 24 hours after the end of surgery
Number of Participants With "Total Response"
Time frame: 24 hours after the end of surgery

Results and safety

Results posted to the registry on 6 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
5mg APD421	176	172
Placebo	166	164

Primary outcome: Number of Participants With Complete Response

Time frame: 24 hours after the end of surgery. Count of participants. Unit: Participants

Measure	APD421 at 5mg n = 176	Placebo n = 166
Value	78	54

APD421 at 5mg vs Placebo: p = 0.033, Chi-squared, Corrected

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 days. Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
APD421 5mg Dose	8 of 176 (4.5%)	169 of 176 (96%)	0 of 176
Placebo	9 of 166 (5.4%)	160 of 166 (96.4%)	0 of 166

Limitations and caveats (from the sponsor): There were no limitations and caveats in this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for PONV

Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Not yet recruitingPhase 4
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
Postoperative Vomiting, Postoperative Nausea and Vomiting

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tong J Gan, MD principal investigator

Duke University Medical College

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing APD421- Amisulpride for IV injection in people with PONV, run by Acacia Pharma Ltd at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Complete Response (time frame: 24 hours after the end of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01991860.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.