Alex Macario MD
A Randomized Controlled Study of Rolapitant for the Prevention of Nausea and Vomiting Following Surgery
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
In adults, there are three major categories of risk factors for PONV: patient specific (female gender, history of PONV or motion sickness, and nonsmoking status), anesthesia related (use of volatile anesthetics, nitrous oxide, and intraoperative and postoperative opioids), and operative (duration and type of surgery). Women are more likely to experience nausea and vomiting after surgery. Some patients require drugs to prevent this nausea and vomiting. The purpose of this study is to 1) find the best dose of rolapitant for the prevention of nausea and vomiting that may occur after surgery 2) to find out the safety and effectiveness of Rolapitant and 3) to find out how well rolapitant works as compared to ondansetron.
Recruiting Status:
CompletedStanford Recruiting Status:
CompletedCondition(s):
Intervention(s):
- Drug: Rolapitant Dose 1 - Rolapitant 5 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
- Drug: Rolapitant Dose 2 - Rolapitant 20 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
- Drug: Rolapitant Dose 3 - Rolapitant 70 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
- Drug: Rolapitant Dose 4 - 200 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
- Drug: Ondansetron - Ondansetron 4 mg x 1 intravenous and rolapitant placebo (4 capsules) x 1 oral on Day 1
- Drug: Placebo - Rolapitant placebo (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Women age 18 or older of any race with an American Society of Anesthesiologists (ASA) physical status of I to III who are scheduled to undergo elective open abdominal surgery under general anesthesia;
2. Postoperative hospitalization expected to last at least 24 hours;
3. Subjects expected to require postoperative intravenous opioid PCA;
4. Subjects whose surgery is expected to require at least 1 hour, but not more than 4 hours, of general anesthesia using the regimen defined in this protocol;
5. Subjects must be able to swallow study medication;
6. Subjects who have a negative serum pregnancy test within 7 days of surgery and a negative urine pregnancy test on the day of surgery or who have been surgically sterilized or are postmenopausal. Subjects of childbearing potential who do not have a negative serum pregnancy test within 7 days of surgery must have a negative serum pregnancy test on the day of surgery. Subjects who have a negative serum pregnancy test within 1 day of surgery do not need a urine pregnancy test on the day of surgery. If approved by the site's institutional review board (IRB), subjects of childbearing potential who are undergoing hysterectomy may have a negative urine pregnancy test on the day of surgery only. Subjects of childbearing potential must have been using a medically acceptable form of birth control for at least 1 month prior to Screening. Subjects of childbearing potential who are not undergoing hysterectomy must be willing to use a medically acceptable form of birth control until completion of Visit 8 (between 30 and 60 days following surgery). Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptive, and surgical sterilization (eg, hysterectomy or tubal ligation);
7. Any preoperative clinical laboratory test results received prior to surgery must be clinically acceptable to the investigator; and
8. Subjects must be willing to give written informed consent and able to adhere to dose and visit schedules, including participation in the Visit 8 follow-up between 30 and 60 days following surgery.
Key Exclusion Criteria:
1. Subjects with clinically significant or unstable cardiac, respiratory, hepatic, renal, or other major organ system disease;
2. Subjects scheduled to receive propofol for maintenance of anesthesia;
3. Subjects with a known hypersensitivity to ondansetron (or any other 5-HT3 antagonist), to any agent that is part of the anesthesia regimen, or to other medications to be administered under this protocol;
4. Subjects who are scheduled to undergo surgery for treatment of infertility with an intention to become pregnant within 2 months following surgery;
5. Subjects who are breast feeding;
6. Subjects who have retching/vomiting or moderate or severe nausea in the 24 hours prior to anesthesia or suffer from chronic nausea and/or vomiting;
7. Subjects who are presently scheduled to undergo gastrointestinal surgery that might be expected to impair the absorption of oral medication (eg, gastric bypass or surgery for duodenal ulcer);
8. Subjects who, in the opinion of the investigator, would experience an unacceptable risk from administration of study drug;
9. Subjects who have been treated with any drug or other treatment with antiemetic efficacy within the last 5 days prior to the start of treatment, or subjects who are scheduled to receive any such drug or other treatment prior to Day 5 of the study. For example, subjects who have received the following drugs within 5 days of surgery or who would need to resume treatment with these drugs within 5 days following surgery should not be enrolled:
a. 5-HT3 antagonists (eg, ondansetron, granisetron, dolasetron, or tropisetron)
b. Antihistamines (eg, diphenhydramine, promethazine, etc)
c. Scopolamine
d. Phenothiazines (eg, prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or
chlorpromazine)
e. Butyrophenones (eg, haloperidol or droperidol)
f. Benzamides (eg, metoclopramide or alizapride)
g. Domperidone
h. Cannabinoids
i. NK1 antagonist (eg, aprepitant)
10. Subjects who are expected to require opioid adjunct medications (eg, gabapentin, pregabalin, dexmedetomidine, ketamine, or clonidine intraoperatively or postoperatively for pain management;
11. Subjects who are expected to require the following analgesics for pain management intraoperatively or while subjects are receiving intravenous PCA: oral opioids (including tramadol) and injectable NSAIDs or local anesthetics, except for 1% to 2% lidocaine injected into the incision during surgery;
12. Subjects with a body mass index (BMI) >40;
13. Subjects with a condition requiring daily opioid use within 7 days prior to surgery;
14. Subjects who are receiving oral or injectable corticosteroids;
15. Subjects who are expected to require placement of a nasogastric tube for gastric suction;
16. Subjects who are expected to require postoperative management in an intensive care or step-down unit or who are otherwise expected to require a prolonged postoperative hospitalization;
17. Subjects who are scheduled to undergo radical hysterectomy or pelvic exenteration;
18. Subjects who have participated in a clinical trial of an investigational drug within 30 days prior to drug
administration;
19. Subjects who are participating in any other clinical study;
20. Subjects who are part of the staff personnel directly involved with this study; and
21. Subjects who are family members of the investigational study staff.
Additional Study Details
Official Title:
A Randomized, Double-Blind, Double-Dummy, Dose-Ranging, Active- and Placebo-Controlled Study of Single-Dose Oral Rolapitant Monotherapy for the Prevention of Postoperative Nausea and Vomiting (PONV)Anticipated start date:
10/2/2007Lead Sponsor:
Schering-PloughInvestigator(s):
Study Type:
InterventionalPurpose:
PreventionAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- No emetic episodes (regardless of rescue medication use) for 0 to 24 hours.
Total Number to be Enrolled:
600Total Number to be Enrolled at Stanford:
12More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
6/12/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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