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NCT02985840
Ondansetron Versus Dexamethasone/Ondansetron to Treat Acute Nausea in the Emergency Department
Phase 4 trial testing Ondansetron in Nausea in 127 participants. Terminated before completion.
15 November 2016
Quick facts
| Lead sponsor | OhioHealth |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 127 |
| Start date | 28 January 2014 |
| Primary completion | 15 November 2016 |
| Estimated completion | 15 November 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ondansetron (ondansetron) — full drug profile →
- Dexamethasone (dexamethasone) — full drug profile →
Conditions studied
- Nausea — all drugs for Nausea →
- Abdominal Pain — all drugs for Abdominal Pain →
Sponsor
OhioHealth — full company profile →
Who can join
18 and older, any sex, with Nausea or Abdominal Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Nausea is a common complaint in patients who present to the emergency department (ED). Although the number of conditions that can present with nausea are numerous, the mainstay of treatment has become intravenous ondansetron (Zofran), not only due to its rapid onset but also its availability. One of the major drawbacks to using this form is that it often needs to be redosed. This study aims to compare intravenous (IV) ondansetron alone versus IV ondansetron given with IV dexamethasone (Decadron) as another viable option when treating patients with nausea in the emergency department. Previous studies in patients undergoing surgical procedures have shown that when IV dexamethasone is given with IV ondansetron to post-operative patients they have less nausea and vomiting than ondansetron alone, and were even found to show decreased post-operative pain associated with nausea. It has also been shown to decrease the need to re-dose antiemetic medication. Although this combination has not been tested in the emergency department it is believed by these investigators that the additional use of dexamethasone may decrease the need to use repeated doses of ondansetron. The investigators believe this may change the way physicians currently approach the nauseated patient in regards to treatment. That rather than possibly giving multiple doses of one medication over and over to reduce a patient's nausea, physicians can give two medications together at one time. The investigators hope to demonstrate that by giving intravenous dexamethasone and ondansetron together, it may be possible to reduce the number of patients who need additional doses of nausea medication.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02985840
- Europe PMC full search
- ASCO Meeting Library
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- NCT06475846 — A Trial of HRS5580 in Prevention of Postoperative Nausea and Vomiting of Adults · Phase 2 · completed
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Other recruiting trials for Nausea
Currently open trials in the same condition.
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Other OhioHealth trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02985840 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by OhioHealth
- Last refreshed: 26 September 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02985840.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing