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NCT02920242
A Study Comparing Two Rifaximin Tablets in Patients With Travelers' Diarrhea.
Phase 3 trial testing Rifaximin (Sandoz GmbH) tablet in Travelers' Diarrhea in 28 participants. Terminated before completion.
23 May 2017
Quick facts
| Lead sponsor | Sandoz |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 15 December 2016 |
| Primary completion | 23 May 2017 |
| Estimated completion | 23 May 2017 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Rifaximin (Sandoz GmbH) tablet — full drug profile →
- Rifaximin (Xifaxan) — full drug profile →
- Placebo
Conditions studied
- Travelers' Diarrhea — all drugs for Travelers' Diarrhea →
Sponsor
Sandoz — full company profile →
Who can join
18 and older, any sex, with Travelers' Diarrhea. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: up to day 5 +/- 1 day. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Other adverse events (6 terms — click to expand)
| Reaction | System | Rifaximin | Xifaxan | Placebo |
|---|---|---|---|---|
| Headache | Nervous system disorders | — | — | — |
| Dizziness | Nervous system disorders | — | — | — |
| Lacrimation increased | Eye disorders | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Medication error | Injury, poisoning and procedural complications | — | — | — |
Data from ClinicalTrials.gov NCT02920242 adverse events section.
Sponsor's own description
This study compared safety and efficacy of a generic rifaximin tablet to the reference listed drug in the treatment of travelers' diarrhea. Additionally both the generic and reference formulations were tested for superiority against a placebo tablet. It was planned that 450 patients would be enrolled, but only 28 patients were randomized. Of these, 1 patient discontinued due to failure to meet the inclusion/exclusion criteria. The remaining 27 patients received study drug and 25 patients completed the study. The study was terminated due to slow enrolment. The final analysis included only safety analysis in the Safety population, due to the low number of randomized patients. No efficacy analysis was performed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02920242
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT02920242 (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 Sandoz
- Last refreshed: 25 March 2019
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/NCT02920242.
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