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Scheduled Prophylactic Antiemetics for Reduction of Emesis With Doxycycline (SPARED) Trial
NA trial testing Ondansetron in Drug-induced Nausea and Vomiting in 319 participants. Completed in 3 April 2019.
| Lead sponsor | University of Rochester |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 319 |
| Start date | 7 October 2015 |
| Primary completion | 3 April 2019 |
| Estimated completion | 3 April 2019 |
| Sites | 1 location across United States |
University of Rochester
Adults 18 to 45, female only, with Drug-induced Nausea and Vomiting. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of participants experiencing symptoms (vomiting or nausea+vomiting) at the time of or after doxycycline
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 45 | |
| Ondansetron | 19 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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