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NCT00448422
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 Bacterial Gastroenteritis in 268 participants. Completed in 1 August 2008.
1 August 2008
Quick facts
| Lead sponsor | Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 268 |
| Start date | 1 December 2006 |
| Primary completion | 1 August 2008 |
| Estimated completion | 1 August 2008 |
| Sites | 1 location across India |
Drugs / interventions tested
- prulifloxacin — full drug profile →
Conditions studied
- Acute Bacterial Gastroenteritis — all drugs for Acute Bacterial Gastroenteritis →
Sponsor
Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) — full company profile →
Who can join
18 and older, any sex, with Acute Bacterial Gastroenteritis. 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 (TLUS)
Time frame: End of Therapy
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 patients with acute bacterial gastroenteritis (traveler's diarrhea.
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 NCT00448422
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) trials
Trials by the same sponsor.
- NCT01691248 — Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in A · Phase 3 · completed
- NCT01591863 — Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Di · Phase 2 · completed
- NCT00468728 — PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) · Phase 3 · completed
- NCT00314951 — Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018) · Phase 3 · completed
- NCT00097422 — OPT-80 in Clostridium Difficile-Associated Diarrhea (CDAD) · Phase 2 · completed
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 NCT00448422 (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 Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Last refreshed: 22 September 2010
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/NCT00448422.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing