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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: Completed Phase 3 study of Uncomplicated Urogenital Gonorrhea, sponsored by Melinta Therapeutics.
NCT02210325 is a Phase 3 study of Uncomplicated Urogenital Gonorrhea that has completed, run by Melinta Therapeutics. The registered enrollment target is 264 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT02210325 record still lists
NCT02210325 is an interventional study that assigns participants to a tested intervention. The registered 264 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower).
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 lists 5 locations in 4 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02210325's enrollment target sits among peer trials
264 1225th of 2000 higher than 773 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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