Scheduled Prophylactic Antiemetics for Reduction of Emesis With Doxycycline (SPARED) Trial (SPARED)
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|ClinicalTrials.gov Identifier: NCT02456662|
Recruitment Status : Recruiting
First Posted : May 28, 2015
Last Update Posted : October 15, 2018
Background/Purpose of the Study Doxycycline is an antibiotic used for infection prevention before surgical pregnancy termination, and a side effect of it is nausea/vomiting. The investigators' study explores whether or not taking the anti-emetic ondansetron prior to doxycycline decreases rates of nausea/vomiting. Patients enrolled in the investigators' study will take either ondansetron or a placebo before they take doxycycline to see if ondansetron decreases their nausea/vomiting. Reducing nausea/vomiting may prevent more infections, and decrease the rates of general anesthesia, patient risks and hospital costs. Decreasing nausea/vomiting will also improve patient experience.
Study Design This will be a randomized controlled trial. Data will be collected by administrating surveys and a log where patients will record the timing of their medications and episodes of nausea/vomiting. The primary outcome is nausea/vomiting after taking the anti-emetic/placebo and doxycycline. 400 eligible patients will be enrolled over two years, 200 in the intervention group and 200 in the placebo group.
Rationale for Study Design A randomized controlled trial will be used to determine the effects of the anti-emetic ondansetron on rates of nausea/vomiting.
Subject Characteristics Patients will be pregnant females, 18-45 years old, who are undergoing surgical termination of pregnancy.
Design 1-2 days before the procedure, patients will complete a demographic questionnaire and a survey about symptoms of nausea/vomiting. They will use a log to record symptoms they experience between taking the anti-emetic/placebo and when they present for their procedure. When patients come to the hospital, they will fill out a repeat survey rating their nausea/vomiting.
|Condition or disease||Intervention/treatment||Phase|
|Drug-induced Nausea and Vomiting||Drug: Ondansetron Drug: Placebo||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial of Scheduled Prophylactic Antiemetics for Reduction of Emesis With Doxycycline|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
Placebo Comparator: Placebo
160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive placebo tablet 30 minutes prior to taking 200mg PO doxycycline
placebo (identical to study medication- ondansetron) PO 30 minutes prior to 200mg PO doxycycline
Active Comparator: Ondansetron
160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive 8mg ondansetron tablet 30 minutes prior to taking 200mg PO doxycycline
8mg PO ondansetron 30 minutes prior to 200mg PO doxycycline
Other Name: zofran
- Nausea and vomiting after doxycycline use [ Time Frame: maximum 24 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456662
|Contact: Sarah J Betstadt, MD, MPH||585-276-5368||sarah_Betstadt@urmc.rochester.edu|
|Contact: Keelin Abbottfirstname.lastname@example.org|
|United States, New York|
|Lattimore Women's Health Practice||Recruiting|
|Rochester, New York, United States, 14620|
|Contact: Keelin Abbott 585-275-2691 email@example.com|
|Principal Investigator:||Sarah J Betstadt, MD, MPH||University of Rochester|