NauseaPONVNCT00956215
Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients
A study testing Aprepitant in people with Nausea and Vomiting, run by University of Pennsylvania at 1 site in United States.
Trial summary
The study drug, Aprepitant, is currently used to control chemotherapy induced nausea and vomiting and is also approved for post-operative nausea and vomiting. The investigators' evaluation of it in morbidly obese patients will demonstrate its ability to control nausea and vomiting post-operatively in this subset of… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Aprepitant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subjects included in this study must be:
- Female
- At least 18 years of age
- Non-smoking
- At high risk for PONV
- Obese with a BMI of at least 45 kg/m2
- Undergoing upper gastrointestinal surgery requiring postoperative opioid analgesia
Who cannot join
- Subjects will be excluded if:
- They have a known allergy to Aprepitant or Ondansetron
- They are currently taking Orap (pimozide), Seldane (terfenadine), Hismanal (astemizole), or Propulsid (cisapride)
- They are pregnant
- They are breastfeeding
- They plan on getting pregnant in the 2 months following surgery
Show all 9Show fewer
- They are not able to receive patient controlled analgesia (PCA) following surgery
- They have a known drug or alcohol abuse problem
- They have chronic nausea and vomiting
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized and Placebo-Controlled Evaluation of Aprepitant for Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients
The study drug, Aprepitant, is currently used to control chemotherapy induced nausea and vomiting and is also approved for post-operative nausea and vomiting. The investigators' evaluation of it in morbidly obese patients will demonstrate its ability to control nausea and vomiting post-operatively in this subset of patients.
Read the detailed description
The purpose of this study is to evaluate the effectiveness of Aprepitant, also known as Emend, in reducing post-operative nausea and vomiting in morbidly obese patients. Post-operative nausea and vomiting that occurs in morbidly obese patients can greatly increase the chances of complications during the post-operative period. By treating morbidly obese patients with Aprepitant, the goal is to reduce the risk of such complications that may be induced by nausea and vomiting.
- Being tested
- Aprepitant, Aprepitant placebo
- Keywords
- post operative, obese
- Medical subject headings
- Nausea, Vomiting, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantDrug
80 mg tablet of Aprepitant with 50 ml of water 30 minutes before surgery
Aprepitant placeboDrug
80 mg placebo tablet with 50 ml of water no later than 30 minutes before induction of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 80mg of Aprepitant | Active comparator | Patients will be randomized to receive 80mg of Aprepitant with 50 ml of water no later than 30 minutes before induction of anesthesia. Receives: Drug: Aprepitant |
| 80 mg of placebo | Placebo comparator | . Patients will be randomized to placebo with 50 ml of water no later than 30 minutes before induction of anesthesia. Receives: Drug: Aprepitant placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of 80mg Aprepitant in preventing post operative nausea or vomiting in morbidly obese patients (BMI of 45 kg/m2 or higher) undergoing upper gastrointestinal surgery.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startMay 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashish Sinha, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956215
- Sponsor's protocol ID
- Emend
- Acronym
- PONV
- Status last verified
- Feb 2012
- First submitted
- 10 Aug 2009
- Last updated
- 16 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized and Placebo-Controlled Evaluation of Aprepitant for Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients
- ClinicalTrials.gov ID
- NCT00956215
- Acronym / sponsor ID
- PONV / Emend
- Keywords
- post operative, obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 11 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study drug, Aprepitant, is currently used to control chemotherapy induced nausea and vomiting and is also approved for post-operative nausea and vomiting. The investigators' evaluation of it in morbidly obese patients will demonstrate its ability to control nausea and vomiting post-operatively in this subset of patients.
Detailed description
The purpose of this study is to evaluate the effectiveness of Aprepitant, also known as Emend, in reducing post-operative nausea and vomiting in morbidly obese patients. Post-operative nausea and vomiting that occurs in morbidly obese patients can greatly increase the chances of complications during the post-operative period. By treating morbidly obese patients with Aprepitant, the goal is to reduce the risk of such complications that may be induced by nausea and vomiting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 80mg of Aprepitant | Active comparator | Drug: AprepitantPatients will be randomized to receive 80mg of Aprepitant with 50 ml of water no later than 30 minutes before induction of anesthesia. |
| 80 mg of placebo | Placebo comparator | Drug: Aprepitant placebo. Patients will be randomized to placebo with 50 ml of water no later than 30 minutes before induction of anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female
- At least 18 years of age
- Non-smoking
- At high risk for PONV
- Obese with a BMI of at least 45 kg/m2
Key exclusion criteria (9 listed)
- They have a known allergy to Aprepitant or Ondansetron
- They are currently taking Orap (pimozide), Seldane (terfenadine), Hismanal (astemizole), or Propulsid (cisapride)
- They are pregnant
- They are breastfeeding
- They plan on getting pregnant in the 2 months following surgery
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 |
|---|---|---|
| Aprepitant80 mg tablet of Aprepitant with 50 ml of water 30 minutes before surgery | Drug | 80mg of Aprepitant |
| Aprepitant placebo80 mg placebo tablet with 50 ml of water no later than 30 minutes before induction of anesthesia. | Drug | 80 mg of placebo |
Primary outcome
To assess the efficacy of 80mg Aprepitant in preventing post operative nausea or vomiting in morbidly obese patients (BMI of 45 kg/m2 or higher) undergoing upper gastrointestinal surgery.
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2012.
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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.
Ashish Sinha, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aprepitant in people with Nausea and Vomiting, run by University of Pennsylvania 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 7 inclusion and 9 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 16 Feb 2012. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the efficacy of 80mg Aprepitant in preventing post operative nausea or vomiting in morbidly obese patients (BMI of 45 kg/m2 or higher) undergoing upper gastrointestinal surgery. (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2012; AzTrials last refreshed its copy on 8 Nov 2026.