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fluconazole · 5 trials · 6 indications
Therapeutic outcome was determined by combination of clinical efficacy and mycological efficacy for each participant as Effective, Ineffective or Indeterminate. The therapeutic outcome was considered as Effective when the clinical efficacy was Cure and the mycological efficacy was Eradication. Primary evaluation of therapeutic outcome was on Day 28. Response rate was calculated based on the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.
| Arm | Type | Description |
|---|---|---|
| Fluconazole | EXPERIMENTAL | - |
| Arm A | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Fluconazole | DRUG | Single oral dose of 150mg Fluconazole |
| Amphotericin B | DRUG | - |
Inclusion Criteria: * Patients with clinical symptoms and signs of vulvovaginal candidiasis. * Patients tested positive for Candida by fungal culture. * Patients who can agree not to have intercourse up to 28 days after dosing. Exclusion Criteria: * Patients with a history of hypersensitivity to ...
Fluconazole is an antifungal medicine studied and used for fungal infections including vulvovaginal candidiasis, esophageal candidiasis, cryptococcal meningitis, tinea capitis (ringworm of the scalp), and other mycoses. Its clinical program includes patients with weakened immune systems, such as those with HIV infection, as well as otherwise healthy adults and children.
Fluconazole is developed and manufactured by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer conducted the Phase 3 clinical program for the drug, including studies in vulvovaginal candidiasis, tinea capitis, and esophageal candidiasis.
Fluconazole has been studied in Phase 3 clinical trials, all of which are listed as completed. The Phase 3 program covered vulvovaginal candidiasis, tinea capitis, esophageal candidiasis, and other fungal infections, with no trials currently listed as active.
Completed Phase 3 trials of fluconazole include NCT01806623 in vulvovaginal candidiasis in Japan, NCT00645242 in children with tinea capitis in the United States and Puerto Rico, NCT00002339 in esophageal candidiasis in immunocompromised patients, and NCT00002277 comparing fluconazole with amphotericin B in fungal infections.
Yes, Diflucan is a brand name for fluconazole. Pfizer's Phase 3 study NCT00645242, which evaluated the drug in children with ringworm of the scalp, was titled as a study of Diflucan, confirming that the two names refer to the same antifungal medicine.
The listed fluconazole Phase 3 trials enrolled approximately 442 patients in total across the studies that report enrollment figures. NCT00645242 enrolled 185 children with tinea capitis, NCT01806623 enrolled 157 women with vulvovaginal candidiasis, and NCT00002339 enrolled 100 patients with esophageal candidiasis.