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A Phase III study of Solithromycin in patients with sinusitis

A Phase III, multi-center, randomized, double-blind, non-inferiority study of Solithromycin versus Cefcapene pivoxil hydrochloride hydrate in patients with sinusitis

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223677
Enrollment
Unknown
Registered
2017-10-13
Start date
2017-10-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinusitis

Interventions

investigational material(s) Generic name etc : Solithromycin INN of investigational material : Solithromycin Therapeutic category code : 614 Antibiotic preparations acting mainly on gram-positive bact

Sponsors

Toyama Chemical Co., Ltd.(Current FUJIFILM Toyama Chemical Co., Ltd.)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Age: 20 years of age and older (at the time of obtaining informed consents) 2.Gender : Both 3.Inpatient/Outpatient status: Outpatient 4.Signed the informed consent form by patients 5.Sinusitis with clear infection symptoms

Exclusion criteria

Exclusion criteria: 1.Having improvement of clinical symptoms due to target disease by other systemic antibiotics 2.Having a history of allergy to macrolide, penicillin or cephem antibiotics 3.Others

Design outcomes

Primary

MeasureTime frame
efficacy and safety profile—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026