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NCT02210325 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea
A Phase 3 study of Uncomplicated Urogenital Gonorrhea, sponsored by Melinta Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 264
- Enrollment target
- 5
- Study locations
NCT02210325 is a Phase 3 study of Uncomplicated Urogenital Gonorrhea that has completed, run by Melinta Therapeutics. The registered enrollment target is 264 participants. The trial reports 5 study locations across 4 states.
The verdict
NCT02210325, a Phase 3 study of Uncomplicated Urogenital Gonorrhea, has completed, sponsored by Melinta Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 264 participants
- Enrollment target
- 5
- Study locations
Study Summary
This study will compare a single dose of oral solithromycin to the standard of care (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with urogenital gonorrhea. A completed open-label Phase 2 study with single doses of solithromycin resulted in 100% microbiological eradication in male and female patients with uncomplicated urogenital gonorrhea.
Conditions Studied
Interventions
- DRUG azithromycin
- DRUG ceftriaxone
- DRUG solithromycin
Study Locations (5)
Ohio
- - Cleveland
- - Toledo
Maryland
- - Baltimore
New South Wales
- - Sydney
Victoria
- - Melbourne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2014-08 |
| Est. Completion | 2017-02-22 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02210325
The ClinicalTrials.gov registry entry for NCT02210325 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 264 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Melinta Therapeutics, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Uncomplicated Urogenital Gonorrhea appearing as the primary indexed condition, and to 3 interventions - of which azithromycin is the first listed.
NCT02210325 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Ohio, Maryland, New South Wales.
Frequently Asked Questions
What is clinical trial NCT02210325 about?
NCT02210325 is a clinical study titled "Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea". This study will compare a single dose of oral solithromycin to the standard of care (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with urogenital gonorrhea. A completed open-label Phase 2 study with single doses of solithromycin resulted in 100% microbiological erad...
What is the current status of trial NCT02210325?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 264 participants. The study started on 2014-08. Estimated completion is 2017-02-22.
What conditions does trial NCT02210325 study?
This clinical trial studies the following conditions: Uncomplicated Urogenital Gonorrhea.
What interventions are being tested in trial NCT02210325?
The interventions under investigation include: azithromycin (DRUG), ceftriaxone (DRUG), solithromycin (DRUG).
Who is sponsoring clinical trial NCT02210325?
This trial is sponsored by Melinta Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02210325 being conducted?
This trial has 5 study locations across Maryland, Ohio, New South Wales, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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