PONVPhase 3NCT02337062

Phase IIIb Study of APD421 in Combination as PONV Prophylaxis

A Phase 3 study testing APD421 in people with PONV, run by Acacia Pharma Ltd at 25 sites in 3 countries.

Completed

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

Trial summary

A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting (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
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,147 participants
Where: 25 sitesin 3 countries
Study dates: Feb 2015to Sep 2015
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
Patients with at least 3 "Apfel" risk factors for PONV

Who cannot join

Patients scheduled to undergo transplant 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

25 sites in 3 countries.

Country

City, postcode or hospital

25 sites in 3 countries

United States14 sites

Albany Medical Center Hospital
Albany, New York, 12208
First Street Surgical Center
Bellaire, Texas, 77401
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
Duke University Medical Center
Durham, North Carolina, 27710
Victory Medical Center Houston
Houston, Texas, 77004
Memorial Hermann-Memorial City Hospital
Houston, Texas, 77024
University of Kansas Medical Center
Kansas City, Kansas, 66160
Jackson Memorial Hospital
Miami, Florida, 33136
UCSF School of Medicine
San Francisco, California, 94143
Helen Keller Hospital
Sheffield, Alabama, 35660
Stony Brook Medicine
Stony Brook, New York, 11794
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157

Other trials in United States

Germany6 sites

HELIOS Klinikum Aue
Aue, 08280
Universitätsklinikum Bonn
Bonn, 53127
Klinikum Ludwigshafen
Ludwigshafen, 67063
Universitätsmedizin Mainz
Mainz, 55131
Philipps University
Marburg, 35033
University Hospitals of Würzburg
Würzburg

Other trials in Germany

France5 sites

University Hospital
Besançon, 25030
Centre Hospitalier Lyon-Sud
Lyon, 69495
Centre Hospitalier de Mulhouse
Mulhouse, 68051
Hopital Foch
Paris
CHU de Hautepierre
Strasbourg

Other trials in France

About this study

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

A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting (PONV).

Conditions: PONV
Being tested: APD421, 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.

APD421Drug
PlaceboDrug

Study groups in NCT02337062
Study group	Role	What they receive
APD421 + standard anti-emetic	Experimental	Single dose of IV APD421 Receives: Drug: APD421
Placebo + standard anti-emetic	Placebo comparator	Single dose of IV placebo 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
Complete response defined as no emesis and no use of rescue medication in the 24 hour period after end of surgery (defined as wound closure)
Measured: 24 hours after the end of surgery

Secondary outcomes (5)

Number of Participants With 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 the end of surgery
Number of Participants Receiving Rescue Medication
Rescue medication defined as an antiemetic (or other medication) given with the intention of relieving nausea and/or emesis, or any incidental use of a drug known to have antiemetic potential
Measured: 24 hours after the end of surgery
Number of Participants With Any 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. "Any nausea" means a score ≥ 1.
Measured: 24 hours after the end of surgery
Number of Participants With 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. "Significant nausea" means a score ≥ 4.
Measured: 24 hours after end of surgery
Time to First Violation of Criteria for PONV
Criteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the end of surgery
Measured: 24 hours after end of surgery

Timeline

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

Feb 2015Sep 2015

First posted13 Jan 2015 (estimated)
Study startFeb 2015
Primary completionSep 2015
Study completionSep 2015

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: 1,147 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02337062
Sponsor's protocol ID: DP10017
Status last verified: Mar 2019
First submitted: 9 Jan 2015
Last updated: 20 Mar 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
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
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting

All PONV trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Combination Prophylaxis Against Post-operative Nausea and Vomiting in High-risk Patients
ClinicalTrials.gov ID: NCT02337062
Acronym / sponsor ID: DP10017
Conditions: PONV
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,147 participants (actual)
Lead sponsor: Acacia Pharma LtdIndustry (pharma, biotech, devices)
Study start: Feb 2015
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 13 Jan 2015 (estimated)
Results: Posted 4 Aug 2017

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 when combined with a standard anti-emetic in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting (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 + standard anti-emetic	Experimental	Drug: APD421Single dose of IV APD421
Placebo + standard anti-emetic	Placebo comparator	Drug: PlaceboSingle dose of IV placebo

Who may qualify

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

Key inclusion criteria (3 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
Patients with at least 3 "Apfel" risk factors for PONV

Key exclusion criteria (4 listed)

Patients scheduled to undergo transplant 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	Drug	APD421 + standard anti-emetic
Placebo	Drug	Placebo + standard anti-emetic

Primary outcome

Number of Participants With Complete Response
Time frame: 24 hours after the end of surgery
Complete response defined as no emesis and no use of rescue medication in the 24 hour period after end of surgery (defined as wound closure)

5 secondary outcomes

Number of Participants With Emesis
Time frame: 24 hours after the end of surgery
Number of Participants Receiving Rescue Medication
Time frame: 24 hours after the end of surgery
Number of Participants With Any Nausea
Time frame: 24 hours after the end of surgery
Number of Participants With Significant Nausea
Time frame: 24 hours after end of surgery
Time to First Violation of Criteria for PONV
Time frame: 24 hours after end of surgery

Results and safety

Results posted to the registry on 4 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
APD421 + Standard Anti-emetic	572	555
Placebo + Standard Anti-emetic	575	556

Primary outcome: Number of Participants With Complete Response

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

Measure	APD421 5mg + Standard Anti-emetic n = 572	Placebo + Standard Anti-emetic n = 575
Value	330	268

APD421 5mg + Standard Anti-emetic vs Placebo + Standard Anti-emetic: p <0.001, Chi-squared

Population analysed: Modified intent-to-treat

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: For the 7 day period after study drug administration. Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
APD421 + Standard Anti-emetic	14 of 572 (2.4%)	111 of 572 (19.4%)	1 of 572
Placebo + Standard Anti-emetic	14 of 575 (2.4%)	120 of 575 (20.9%)	0 of 575

Limitations and caveats (from the sponsor): There were no limitations and caveats that occurred during the duration of this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 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
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, 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.

Peter Kranke, MD principal investigator

Würzburg University Hospitals

25 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing APD421 in people with PONV, run by Acacia Pharma Ltd at 25 sites in 3 countries.

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 3 inclusion and 4 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 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Germany, France. 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 4 Aug 2017). 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 NCT02337062.

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 20 Mar 2019.