PONVPhase 3NCT01991821

European Phase III Study of APD421 in PONV

A Phase 3 study testing APD421 in people with PONV, run by Acacia Pharma Ltd at 2 sites in 2 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 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
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 368 participants
Where: 2 sitesin 2 countries
Study dates: Jul 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

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

France1 site

CHU de Hautepierre
Strasbourg

Other trials in France

Germany1 site

University Hospitals of Würzburg
Würzburg

Other trials in Germany

About this study

Official title: Randomised, 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, 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 NCT01991821
Study group	Role	What they receive
APD421	Experimental	IV APD421 single dose Receives: Drug: APD421
Placebo	Placebo comparator	IV placebo single dose Receives: Drug: Placebo

What is being measured

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

Complete Response (no Emesis, Significant Nausea or Rescue Medication)
The primary efficacy analysis was a comparison of the incidence of Complete Response (absence of PONV1) in the 0-24-hour period after surgery, between the active treatment group and the placebo group using Pearson square test with Yates's continuity correction at a two-sided significance level of 5%.
Measured: 24 hours after end of surgery

Secondary outcomes (6)

Complete Response (no Emesis or Rescue Medication)
Measured: 24 hrs after end of surgery
Total Response (no Emesis, Nausea or Rescue Medication)
Measured: 24 hrs after end of surgery
Incidence of Emesis (Vomiting/Retching)
An assessment of a participant experiencing an episode of emesis (vomiting/ retching) or received anti-emetic rescue medication during the 24hours after the completion of the surgery
Measured: 24 hours after end of surgeryry
Incidence of Nausea
Count of patients experiencing an episode of nausea scored ≥ 1 of 0-10 verbal response scale during the 24 hours period after the completion of surgery
Measured: 24 hours after end of surgery
Incidence of Significant Nausea
Count of participants with nausea score ≥ 4 on 0-10 verbal response scale
Measured: 24 hours after end of surgery
Use of Rescue Medication
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.

Jul 2013Jan 2014

First posted25 Nov 2013 (estimated)
Study startJul 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: 368 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01991821
Sponsor's protocol ID: DP10014
Status last verified: Aug 2019
First submitted: 11 Nov 2013
Last updated: 20 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 Aug 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 Prophylaxis Against Post-operative Nausea and Vomiting
ClinicalTrials.gov ID: NCT01991821
Acronym / sponsor ID: DP10014
Conditions: PONV
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 368 participants (actual)
Lead sponsor: Acacia Pharma LtdIndustry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 25 Nov 2013 (estimated)
Results: Posted 2 Aug 2019

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: APD421IV APD421 single dose
Placebo	Placebo comparator	Drug: PlaceboIV placebo single dose

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	Drug	APD421
Placebo	Drug	Placebo

Primary outcome

Complete Response (no Emesis, Significant Nausea or Rescue Medication)
Time frame: 24 hours after end of surgery
The primary efficacy analysis was a comparison of the incidence of Complete Response (absence of PONV1) in the 0-24-hour period after surgery, between the active treatment group and the placebo group using Pearson square test with Yates's continuity correction at a two-sided significance level of 5%.

6 secondary outcomes

Complete Response (no Emesis or Rescue Medication)
Time frame: 24 hrs after end of surgery
Total Response (no Emesis, Nausea or Rescue Medication)
Time frame: 24 hrs after end of surgery
Incidence of Emesis (Vomiting/Retching)
Time frame: 24 hours after end of surgeryry
Incidence of Nausea
Time frame: 24 hours after end of surgery
Incidence of Significant Nausea
Time frame: 24 hours after end of surgery
Use of Rescue Medication
Time frame: 24 hours after end of surgery

Results and safety

Results posted to the registry on 2 Aug 2019, 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	169	6
Placebo	178	11

Primary outcome: Complete Response (no Emesis, Significant Nausea or Rescue Medication)

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

Measure	APD421 n = 169	Placebo n = 178
Value	95	83

APD421 vs Placebo: p = 0.093, Chi-squared, Corrected

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Any AE that is serious occurring during the course of the study, irrespective of the treatment received by the subject must be reported to the pharmacovigilance provider within 24hours of it's recognition. Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
APD421 at 5mg	3 of 169 (1.8%)	91 of 169 (53.8%)	0 of 169
Placebo	4 of 178 (2.2%)	178 of 178 (100%)	0 of 178

Limitations and caveats (from the sponsor): There are no limitations and caveats with this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 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.

Pierre Diemunsch, MD principal investigator

Hôpital de Hautepierre

2 sites in 2 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 2 sites in 2 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 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 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France, Germany. 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 2 Aug 2019). 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?

Complete Response (no Emesis, Significant Nausea or Rescue Medication) (time frame: 24 hours after 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 NCT01991821.

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 Aug 2019.