CClinicalTrials.gg
Sign In
CompletedNCT00666185Updated Sep 18, 2014

Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

A Phase 3 interventional study of Micafungin and Fluconazole in Candidiasis, Oral, sponsored by Astellas Pharma Inc. Completed at 37 sites in 3 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2014-09-18.

Sponsored by Astellas Pharma Inc · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
523
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study summary

To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment of patients with Esophageal Candidiasis

02

Conditions studied

  • Candidiasis, Oral

Keywords

  • Micafungin
  • Esophageal Candidiasis
  • Fluconazole
03

In context

Candidiasis

265 studies on the registry are indexed under Candidiasis; 20 are open to participants now.

This study's enrollment of 523 is above the median of 99 across 186 interventional studies indexed under Candidiasis.

Browse Candidiasis studies →

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of esophageal candidiasis confirmed by endoscopy
  • Negative pregnancy test in females of childbearing potential

Exclusion criteria

Exclusion Criteria:

  • Pregnant or nursing
  • Evidence of liver disease
  • Presence of another active opportunistic fungal infection and/or receiving acute systemic therapy for an opportunistic fungal infection
  • Concomitant esophagitis caused by herpes simplex virus or cytomegalovirus
  • Receipt of an oral or topical antifungal agent within 48 hours or a systemic agent within 72 hours of first dose of study drug
  • Non-responsive to therapy in any prior systemic antifungal clinical trail
  • History of > 2 episodes of esophageal candidiasis requiring systemic antifungal therapy
  • History of anaphylaxis attributed to azole compounds or echinocandin class of antifungals
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
523 participants (actual)

Study arms

  • Experimental
    1

    Drug: Micafungin

  • Active comparator
    2

    Drug: Fluconazole

Interventions

  • DrugMicafungin

    IV

    Also known as: Mycamine, FK463

  • DrugFluconazole

    IV

    Also known as: Diflucan

06

What researchers measure

Primary outcomes

  1. Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy

    Time frame: End of Therapy

Secondary outcomes

  1. Clinical response at end of therapy of cleared or improved

    Time frame: End of Therapy

  2. Mucosal response at end of therapy of cleared or improved

    Time frame: End of Therapy

07

Study locations

37 sites
  • Abadia Uberaba, Brazil
  • Barretos, Brazil
  • 5 Sites
    Belo Horizonte, Brazil
  • Boqueirao - Santos, Brazil
  • 2 Sites
    Campinas, Brazil
  • 2 Sites
    Curitiba, Brazil
  • Goiania, Brazil
  • Maruipe Victoria, Brazil
  • Nova Iguacu, Brazil
  • Parquelandia - Fortaleza, Brazil
  • Porto Alegre, Brazil
  • Quinta - Natal, Brazil
  • 4 Sites
    Rio de Janeiro, Brazil
  • 2 Sites
    Salvador, Brazil
  • Sao Jose do Rio Preto, Brazil
  • 8 Sites
    Sao Paulo, Brazil
  • 4 Sites
    Lima, Peru
  • Arcadia-Pretoria, South Africa
  • Bellville - Cape Town, South Africa
  • 2 Sites
    Bloemfontein, South Africa
  • Brits, South Africa
  • Cape Town, South Africa
  • Centurion, South Africa
  • Dundee, South Africa
  • 2 Sites
    Durban, South Africa
  • Hatfield - Pretoria, South Africa
  • Johannesburg, South Africa
  • Olifantsfontein, South Africa
  • Paarl, South Africa
  • 2 Sites
    Port Elizabeth, South Africa
  • Potchefstroom, South Africa
  • Pretoria West, South Africa
  • 3 Sites
    Pretoria, South Africa
  • Reiger Park, South Africa
  • Richards Bay, South Africa
  • Somerset West, South Africa
  • Westdene - Bloemfontein, South Africa
08

References and documents

Publications

  • de Wet NT, Bester AJ, Viljoen JJ, Filho F, Suleiman JM, Ticona E, Llanos EA, Fisco C, Lau W, Buell D. A randomized, double blind, comparative trial of micafungin (FK463) vs. fluconazole for the treatment of oesophageal candidiasis. Aliment Pharmacol Ther. 2005 Apr 1;21(7):899-907. doi: 10.1111/j.1365-2036.2005.02427.x. PubMed 15801925 ↗
  • Andes DR, Reynolds DK, Van Wart SA, Lepak AJ, Kovanda LL, Bhavnani SM. Clinical pharmacodynamic index identification for micafungin in esophageal candidiasis: dosing strategy optimization. Antimicrob Agents Chemother. 2013 Nov;57(11):5714-6. doi: 10.1128/AAC.01057-13. Epub 2013 Aug 19. PubMed 23959319 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00666185
Lead sponsor
Astellas Pharma Inc
Responsible party
Sponsor
First posted
Apr 24, 2008
Start date
Aug 2003
Primary completion
Feb 2004
Completion
Feb 2004
Last update
Sep 18, 2014

Study contacts

Use central contact
study director · Astellas Pharma US, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Candidiasis→

Other studies from this sponsor

Astellas Pharma Inc

Start the discussion