Postoperative Nausea and VomitingPhase 2NCT00895830
Dose-ranging Study of APD405 in Post-operative Nausea and Vomiting (PONV)
A Phase 2 study testing APD405 in people with Postoperative Nausea and Vomiting, run by Acacia Pharma Ltd at 18 sites in 4 countries.
Trial summary
To assess the efficacy and safety of different doses of APD405 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- APD405
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 257 participants
- Where
- 18 sitesin 4 countries
- Study dates
- May 2009to Nov 2009
- Phase
- Phase 2
- 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
- Written informed consent
- Patients undergoing elective surgery under general anaesthesia requiring at least one overnight stay in hospital for either:
- Hysterectomy (any surgical technique)
- Cholecystectomy (any surgical technique)
- Other elective surgery requiring overnight admission to hospital and scheduled to last at least 1 hour from induction of anaesthesia
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- Patients with at least 2 risk factors for PONV, defined as 2 of the following:
- Past history of PONV and/or motion sickness
- Non-smoking status
- Female gender
- Planned opiate use for post-operative analgesia
- American Society of Anesthesiologists (ASA) risk score I-III (see Appendix 3)
- Adequate hepatic and renal function
- Alanine aminotransferase (ALT) <2.5 * upper limit normal (ULN)
- Aspartate aminotransferase (AST) <2.5 * ULN
- Bilirubin <1.5 * ULN
- Creatinine <1.5 * ULN
- Adequate haematological function
- Haemoglobin ≥9.5 g/dL
- White blood count 4.0-11.0 * 10^9/L
- Platelet count ≥150 - 400 * 10^9/L
- Ability and willingness to give written informed consent
Who cannot join
- Patients undergoing outpatient/day case surgery
- Patients undergoing surgery where the patient is expected to remain ventilated for a period after surgery
- Patients undergoing intra-thoracic, transplant or central nervous system surgery
- Patients receiving a local anaesthetic/regional neuraxial (intrathecal or epidural) block
- Patients receiving monoamine oxidase inhibitor (MAOI) therapy currently or in the preceding 3 weeks
- Patients with a pre-existing vestibular disorder or history of dizziness
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- Patients that are expected to need a naso- or oral-gastric tube in situ after surgery is completed
- Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
- Patients treated with regular anti-emetic therapy including corticosteroids
- Patients receiving CYP3A4 inducers or inhibitors within 7 days prior to study including but not limited to erythromycin, itraconazole, nefazodone, diltiazem, verapamil, rifampicin
- Patients with pre-existing nausea or vomiting 24 hours before surgery
- Patients who are breast feeding or pregnant
- Patients with a history of alcohol abuse
- Patients diagnosed with Parkinson's disease
- Patients who have received anti-cancer chemotherapy in the previous 4 weeks
- Patients with pre-existing clinically significant cardiac arrhythmia
- Patients with a history of epilepsy
- Patients who have participated in a previous study within the last 28 days (French sites only: Patients who have participated in a previous study within the last 6 months, if required by national or local regulations)
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
France7 sites
University Hospital
Besançon
Hôpital mère enfant
Bron, 69500
Hôpital Huriez
Lille
University Hospital
Nancy
Hôpital FOCH
Paris
University Hospital
Reims
Hautepierre Hospital
Strasbourg, 67000
Germany6 sites
Charité - Universitätsmedizin
Berlin
Universität Heidelberg
Heidelberg
University of Leipzig
Leipzig
Klinikum Ludwigshafen
Ludwigshafen
Philipps University
Marburg
University Hospitals of Würzburg
Würzburg
United States3 sites
Duke University Medical Center
Durham, North Carolina, 27710
Memorial Hermann-Memorial City Hospital
Houston, Texas, 77024
UCSF Medical Center at Mt Zion
San Francisco, California, 94115
Switzerland2 sites
Geneva University Hospitals
Geneva
Centre Hospitalier Universitaire Vaudois
Lausanne
About this study
Official title: Randomised, Double-blind, Placebo-controlled, Phase II Study to Assess the Safety and Efficacy of Different Doses of Intravenous APD405 for the Prevention of Post-operative Nausea and Vomiting
To assess the efficacy and safety of different doses of APD405 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- APD405, 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.
APD405Drug
IV
PlaceboDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Experimental | 0.3mg dose level Receives: Drug: APD405 |
| 3 | Experimental | 1mg dose level Receives: Drug: APD405 |
| 4 | Experimental | 2mg dose level Receives: Drug: APD405 |
| 5 | Experimental | 3mg dose level Receives: Drug: APD405 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experienced Post-operative Nausea or Vomiting
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2009
- Study completionNov 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acacia Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Martin Tramèr, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895830
- Sponsor's protocol ID
- DP10002
- Status last verified
- Mar 2011
- First submitted
- 7 May 2009
- Last updated
- 29 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kranke P, Rohm KD, Diemunsch P, Gan TJ, Apfel CC, Eberhart L, Minkowitz HS, Wallenborn J, Chassard D, Lebuffe G, Fox GM, Tramer MR. Intravenous buspirone for the prevention of postoperative nausea and vomiting. Eur J Clin Pharmacol. 2012 Nov;68(11):1465-72. doi: 10.1007/s00228-012-1284-8. Epub 2012 May 1.
PubMed 22546895
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo-controlled, Phase II Study to Assess the Safety and Efficacy of Different Doses of Intravenous APD405 for the Prevention of Post-operative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT00895830
- Acronym / sponsor ID
- DP10002
- Conditions
- Postoperative Nausea and Vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Acacia Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 8 May 2009 (estimated)
- Results
- Posted 24 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy and safety of different doses of APD405 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Experimental | Drug: APD4050.3mg dose level |
| 3 | Experimental | Drug: APD4051mg dose level |
| 4 | Experimental | Drug: APD4052mg dose level |
| 5 | Experimental | Drug: APD4053mg dose level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Male or female patients ≥ 18 years of age
- Written informed consent
- Patients undergoing elective surgery under general anaesthesia requiring at least one overnight stay in hospital for either:
- Patients with at least 2 risk factors for PONV, defined as 2 of the following:
- American Society of Anesthesiologists (ASA) risk score I-III (see Appendix 3)
Key exclusion criteria (18 listed)
- Patients undergoing outpatient/day case surgery
- Patients undergoing surgery where the patient is expected to remain ventilated for a period after surgery
- Patients undergoing intra-thoracic, transplant or central nervous system surgery
- Patients receiving a local anaesthetic/regional neuraxial (intrathecal or epidural) block
- Patients receiving monoamine oxidase inhibitor (MAOI) therapy currently or in the preceding 3 weeks
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 |
|---|---|---|
| APD405IV | Drug | 2, 3, 4, 5 |
| PlaceboIV | Drug | 1 |
Primary outcome
Experienced Post-operative Nausea or Vomiting
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22546895Kranke P, Rohm KD, Diemunsch P, Gan TJ, Apfel CC, Eberhart L, Minkowitz HS, Wallenborn J, Chassard D, Lebuffe G, Fox GM, Tramer MR. Intravenous buspirone for the prevention of postoperative nausea and vomiting. Eur J Clin Pharmacol. 2012 Nov;68(11):1465-72. doi: 10.1007/s00228-012-1284-8. Epub 2012 May 1.
Related trials for Postoperative Nausea and Vomiting
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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
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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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.
Martin Tramèr, MD principal investigator
University Hospital, Geneva
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APD405 in people with Postoperative Nausea and Vomiting, run by Acacia Pharma Ltd at 18 sites in 4 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 22 inclusion and 18 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 29 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Germany, United States, Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 24 Mar 2011). 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?
Experienced Post-operative Nausea or Vomiting (time frame: 24 hours). 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 NCT00895830, which also lists 1 linked publication.
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 29 Mar 2011.