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NCT00392574
A Multicenter, Double-Blind, Randomized Study to Compare The Safety and Efficacy of Prulifloxacin Versus Placebo in the Treatment of Acute Gastroenteritis in Adult Travelers
Phase 3 trial testing Prulifloxacin in Acute Gastroenteritis in Adult Travelers in 282 participants. Completed in 1 March 2008.
1 February 2008
Quick facts
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 282 |
| Start date | 1 August 2006 |
| Primary completion | 1 February 2008 |
| Estimated completion | 1 March 2008 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Prulifloxacin — full drug profile →
- Placebo
Conditions studied
- Acute Gastroenteritis in Adult Travelers — all drugs for Acute Gastroenteritis in Adult Travelers →
Sponsor
Merck Sharp & Dohme LLC — full company profile →
Who can join
18 and older, any sex, with Acute Gastroenteritis in Adult Travelers. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Time to last unformed stool
Time frame: Study days 1-3
Sponsor's own description
The objective of this pivotal Phase III study is to investigate the safety and efficacy of prulifloxacin versus placebo in the treatment of subjects with acute bacterial gastroenteritis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00392574
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT00392574 (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 Merck Sharp & Dohme LLC
- Last refreshed: 27 April 2015
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/NCT00392574.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing