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Trial record 1 of 1 for:    A0561023
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The Study Of Fluconazole For Vulvovaginal Candidiasis

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ClinicalTrials.gov Identifier: NCT01806623
Recruitment Status : Completed
First Posted : March 7, 2013
Results First Posted : December 3, 2014
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 28, 2013
First Posted Date  ICMJE March 7, 2013
Results First Submitted Date  ICMJE August 14, 2014
Results First Posted Date  ICMJE December 3, 2014
Last Update Posted Date March 31, 2017
Actual Study Start Date  ICMJE March 5, 2013
Actual Primary Completion Date November 22, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2017)
Therapeutic Outcome: Response Rate [ Time Frame: Day 7, Day 14 and Day 28 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
  • Therapeutic outcome: Evaluated by combination of clinical response and mycological response for each subject as effective, ineffective or indeterminate. [ Time Frame: Day 7 ]
  • Therapeutic outcome: Evaluated by combination of clinical response and mycological response for each subject as effective, ineffective or indeterminate. [ Time Frame: Day 14 ]
  • Therapeutic outcome: Evaluated by combination of clinical response and mycological response for each subject as effective, ineffective or indeterminate. [ Time Frame: Day 28 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2017)
  • Clinical Efficacy: Cure Rate [ Time Frame: Day 7, Day 14 and Day 28 ]
    Scores of severity in signs and symptoms at each observation dates were compared with those before the treatment and the clinical efficacy was determined as Cure (the clinical symptom disappeared), Improvement (the clinical symptom was improved: the total score of clinical symptom was reduced relative to the total score before the treatment), Failure (the criteria for Cure and Improvement were not met, or other systemic antifungal drugs or local antifungal drugs were administered for the treatment of the disease to be examined) or Indeterminate (efficacy for each item was not determined for the reasons including failure to conduct the test, or other systemic antifungal agents or local antifungal drugs were administered for the treatment of infections other than the disease to be examined). Cure rate was calculated based on the following formula, "the number of participants assessed as Cure" over "total participants excluding ones assessed as Indeterminate" multiplied by 100.
  • Clinical Efficacy: Cure and Improvement Rate [ Time Frame: Day 7, Day 14 and Day 28 ]
    Scores of severity in signs and symptoms on each observation dates are compared with those before the treatment and the clinical efficacy is determined as Cure (the clinical symptom disappeared), Improvement (the clinical symptom was improved), Failure (the criteria for Cure and Improvement were not met, or other systemic antifungal drugs or local antifungal drugs were administered for the treatment of the disease to be examined) or Indeterminate (efficacy for each item was not determined for the reasons including failure to conduct the test, or other systemic antifungal agents or local antifungal drugs were administered for the treatment of infections other than the disease to be examined). Cure and improvement rate was calculated based on the following formula, "the number of participants assessed as Cure or Improvement" over "total participants excluding ones assessed as Indeterminate" multiplied by 100.
  • Mycological Efficacy: Eradication Rate [ Time Frame: Day 7, Day 14 and Day 28 ]
    Determined based on the results of culture of Candida as Eradication, Persistent or Indeterminate. Eradication rate was calculated based on the following formula, "the number of participants assessed as Eradication" over "total participants excluding ones assessed as Indeterminate" multiplied by 100.
  • Total Scores for Clinical Symptoms [ Time Frame: Day 1 (before dosing), Day 3, Day 7, Day 14 and Day 28 ]
    Sum of severity scores in vulvovaginal itching, vulvovaginal burning sensation, excoriation of vulva, vaginal discharge, vulva oedema, redness of vulva, vaginal redness, property of vaginal content. Higher scores show greater severity. Total Scores for Clinical Symptoms Severity range from 0 (best possible outcome) to 24 (worst possible outcome).
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
  • Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
  • Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
  • Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
    Area under the concentration time-curve from zero to the last measured concentration (AUClast) for Vaginal Fluid Fluconazole Concentration adjusted by Sample Weight
  • Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
  • Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
    Area under the concentration time-curve from zero to the last measured concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid
Original Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
  • Clinical efficacy [ Time Frame: Day 7 ]
    Response to treatment on signs and symptoms of vulvovaginal infection. Total score of severity in signs and symptoms on each observation date are compared with those before the treatment and the clinical efficacy is determined as Cure, Improvement, Ineffective or Indeterminate.
  • Clinical efficacy [ Time Frame: Day 14 ]
    Response to treatment on signs and symptoms of vulvovaginal infection. Total score of severity in signs and symptoms on each observation date are compared with those before the treatment and the clinical efficacy is determined as Cure, Improvement, Ineffective or Indeterminate.
  • Clinical efficacy [ Time Frame: Day 28 ]
    Response to treatment on signs and symptoms of vulvovaginal infection. Total score of severity in signs and symptoms on each observation date are compared with those before the treatment and the clinical efficacy is determined as Cure, Improvement, Ineffective or Indeterminate.
  • Mycological efficacy: Determined based on the results of culture for Candida albicans as Eradication, Persistent or Indeterminate. [ Time Frame: Day 7 ]
  • Mycological efficacy: Determined based on the results of culture for Candida albicans as Eradication, Persistent or Indeterminate. [ Time Frame: Day 14 ]
  • Mycological efficacy: Determined based on the results of culture for Candida albicans as Eradication, Persistent or Indeterminate. [ Time Frame: Day 28 ]
  • Clinical symptoms [ Time Frame: Day 3 ]
    Determined based on the score of severity in Vulvovaginal itching, vulvovaginal burning sensation, excoriation of vulva, vaginal discharge, vulva oedema, redness of vulva, vaginal redness, property of vaginal content
  • Clinical symptoms [ Time Frame: Day 7 ]
    Determined based on the score of severity in Vulvovaginal itching, vulvovaginal burning sensation, excoriation of vulva, vaginal discharge, vulva oedema, redness of vulva, vaginal redness, property of vaginal content
  • Clinical symptoms [ Time Frame: Day 14 ]
    Determined based on the score of severity in Vulvovaginal itching, vulvovaginal burning sensation, excoriation of vulva, vaginal discharge, vulva oedema, redness of vulva, vaginal redness, property of vaginal content
  • Clinical symptoms [ Time Frame: Day 28 ]
    Determined based on the score of severity in Vulvovaginal itching, vulvovaginal burning sensation, excoriation of vulva, vaginal discharge, vulva oedema, redness of vulva, vaginal redness, property of vaginal content
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
  • Maximum Observed vaginal discharge Concentration (Cmax) [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
  • Time to Reach Maximum Observed vaginal discharge Concentration (Tmax) [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Study Of Fluconazole For Vulvovaginal Candidiasis
Official Title  ICMJE A Multicenter Open-label Non-comparative Study Of Fluconazole For The Treatment Of Vulvovaginal Candidiasis.
Brief Summary As for the indication of vulvovaginal candidiasis, a single oral administration of fluconazole 150 mg has been approved and is recommended by guidelines overseas. However in Japan oral therapy with antifungal triazole such as Fluconazole has not been approved, and topical therapies such as vaginal tablets, pessary and cream are used clinically. The purpose of this trial is to confirm the efficacy and safety of single oral administration of fluconazole 150 mg for the treatment of vulvovaginal candidiasis in Japanese patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vulvovaginal Candidiasis
Intervention  ICMJE Drug: Fluconazole
Single oral dose of 150mg Fluconazole
Study Arms  ICMJE Experimental: Fluconazole
Intervention: Drug: Fluconazole
Publications * Mikamo H, Matsumizu M, Nakazuru Y, Okayama A, Nagashima M. Efficacy and safety of a single oral 150 mg dose of fluconazole for the treatment of vulvovaginal candidiasis in Japan. J Infect Chemother. 2015 Jul;21(7):520-6. doi: 10.1016/j.jiac.2015.03.011. Epub 2015 Mar 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2013)
157
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2013)
130
Actual Study Completion Date  ICMJE November 22, 2013
Actual Primary Completion Date November 22, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • Patients with severe renal dysfunction.
  • Patients with liver disorder.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01806623
Other Study ID Numbers  ICMJE A0561023
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP