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Trial record 18 of 27 for:    Clotrimazole AND Fungal Infections

Comparative Efficacy Study of 10 mg Dequalinium Chloride (Fluomizin) in the Treatment of Vulvovaginal Candidiasis

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ClinicalTrials.gov Identifier: NCT02242695
Recruitment Status : Completed
First Posted : September 17, 2014
Last Update Posted : September 15, 2016
Sponsor:
Collaborator:
Mahidol University
Information provided by (Responsible Party):
Medinova AG

Tracking Information
First Submitted Date  ICMJE October 23, 2013
First Posted Date  ICMJE September 17, 2014
Last Update Posted Date September 15, 2016
Study Start Date  ICMJE November 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2014)
Clinical cure rate [ Time Frame: Control 1 at day 4 after therapy end ]
Clinical cure rate is defined as Total Severity Score (TSC) ≤ 2
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02242695 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2014)
  • Microbiological cure rate [ Time Frame: Control 1 at 4 days after therapy end ]
    Negative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture
  • Therapeutic cure rate [ Time Frame: Control 1 at 4 days after therapy end ]
    Clinically and microbiologically cured
  • Individual clinical signs and symptoms [ Time Frame: Control 1 at 4 days after therapy end ]
    4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation
  • Presence of dyspareunia [ Time Frame: Control 1 at 4 days after therapy end ]
    yes/no
  • Direct microscopy (wet smear) [ Time Frame: Control 1 at 4 days after therapy end ]
    Presence or absence of Candida hyphea or spores
  • vaginal pH [ Time Frame: Control 1 at 4 days after therapy end ]
  • Candida culture [ Time Frame: Control 1 at 4 days after therapy end ]
    positive / negative for Candida spp
  • Global assessment of efficacy [ Time Frame: Control 1 at 4 days after therapy end ]
    4-point rating scale assessed by investigator and patient
  • Patient Satisfaction [ Time Frame: Control 1 at 4 days after therapy end ]
    presence of vaginal discomfort, increased discharge, burning sensation
  • Adverse event [ Time Frame: Control 1 at 4 days after therapy end ]
    Number of participants experiencing an adverse event
  • Global assessment of tolerability [ Time Frame: Control 1 at 4 days after therapy end ]
    4-point rating scale by investigator and patient
  • Clinical cure rate [ Time Frame: Control 2 at 6 weeks after therapy end ]
    Clinical cure rate defined as Total Symptom Score TSC ≤ 2
  • Presence of external dysuria [ Time Frame: Control 1 at 4 days after therapy end ]
    yes/no
  • Microbiological cure rate [ Time Frame: Control 2 at 6 weeks after therapy end ]
    Negative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture
  • Therapeutic cure rate [ Time Frame: Control 2 at 6 weeks after therapy end ]
    Clinically and microbiologically cured
  • Individual clinical signs and symptoms [ Time Frame: Control 2 at 6 weeks after therapy end ]
    4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation
  • Presence of dyspareunia [ Time Frame: Control 2 at 6 weeks after therapy end ]
    yes/no
  • Direct microscopy (wet smear) [ Time Frame: Control 2 at 6 weeks after therapy end ]
    Presence or absence of Candida hyphea or spores
  • vaginal pH [ Time Frame: Control 2 at 6 weeks after therapy end ]
  • Candida culture [ Time Frame: Control 2 at 6 weeks after therapy end ]
    positive / negative for Candida spp
  • Global assessment of efficacy [ Time Frame: Control 2 at 6 weeks after therapy end ]
    4-point rating scale assessed by investigator and patient
  • Patient Satisfaction [ Time Frame: Control 2 at 6 weeks after therapy end ]
    presence of vaginal discomfort, increased discharge, burning sensation
  • Adverse event [ Time Frame: Control 2 at 6 weeks after therapy end ]
    Number of participants experiencing an adverse event
  • Global assessment of tolerability [ Time Frame: Control 2 at 6 weeks after therapy end ]
    4-point rating scale by investigator and patient
  • Presence of external dysuria [ Time Frame: Control 2 at 6 weeks after therapy end ]
    yes/no
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Efficacy Study of 10 mg Dequalinium Chloride (Fluomizin) in the Treatment of Vulvovaginal Candidiasis
Official Title  ICMJE Comparative Study of the Efficacy of 10.0 mg Dequalinium Chloride (Fluomizin®) and 100 mg Clotrimazole (Canesten®) for the Treatment of Vulvovaginal Candidiasis
Brief Summary A clinical study to compare the clinical efficacy of vaginal tablets containing 10mg dequalinium chloride (Fluomizin) with the clinical efficacy of 100mg clotrimazole in patients suffering from vulvovaginal candidiasis, to assess safety of the two medications during the treatment, and to evaluate women's satisfaction with the two treatments.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Vulvovaginal Candidiasis
Intervention  ICMJE
  • Drug: Fluomizin vaginal tablets
    One vaginal tablet for 6 days and 1 placebo tablet on day 7
    Other Names:
    • 10 mg dequalinium chloride vaginal tablets
    • Donaxyl vaginal tablets
    • Naxyl vaginal tablets
  • Drug: Canesten vaginal tablets
    one vaginal tablet for 7 days
    Other Name: 100mg clotrimazole vaginal tablets
Study Arms  ICMJE
  • Experimental: Fluomizin vaginal tablets
    Fluomizin vaginal tablets containing 10mg dequalinium chloride once daily for 6 days and one placebo vaginal tablet on day 7
    Intervention: Drug: Fluomizin vaginal tablets
  • Active Comparator: Canesten vaginal tablets
    Canesten vaginal tablets containing 100mg clotrimazole once daily for 7 days
    Intervention: Drug: Canesten vaginal tablets
Publications * Not Provided

*   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: September 15, 2014)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical signs and symptoms of vulvovaginal candididiasis as Total Severity Score, Total Severity Score of at least 4 (0-15: vaginal itching (0-3), vaginal burning or soreness (0-3), abnormal vaginal discharge (0-3),vulvo/vaginal erythema or edema(0-3), vulvar excoriation or fissure formation (0-3).
  • Direct microscopy (Wet smear) positive for yeast forms (hyphae/pseudohyphae) or budding yeasts.
  • normal vaginal pH (higher than 4.5) at baseline.
  • Women aged 18 - 45 years old.
  • Women can comply with all clinical trial instructions, and can return to all follow-up visits.
  • Signed Written Informed Consent to participate in this study.

Exclusion Criteria:

  • Recurrent vulvovaginal candidiasis(4 episodes of VVC in the last 12 months).
  • Women with other cause of vaginal infections, e.g. bacterial vaginosis, aerobic vaginitis, trichomoniasis, and mixed infections
  • Women using oral or vaginal antifungals within 2 weeks prior to enrolment and during the study.
  • Women using any intra-vaginal products, also vaginal douches containing soaps and other anionic, surface-active substances, within 2 weeks prior to enrolment and during the study.
  • Women using any antibiotic or anti-infective within 2 weeks prior to enrolment.
  • Cervicitis, abnormal PAP smear in the last 6 month.
  • Severe systemic diseases (HIV infection, diabetes mellitus, cancer, tuberculosis, autoimmune diseases, severe psychiatric conditions, etc.).
  • Women with confirmed Neisseria gonorrhoea or Chlamydia trachomatis.
  • Women having menstruation bleeding at enrolment.
  • Known or suspected hypersensitivity to one of the study medications, inclusive their excipients.
  • Participation of patient in another investigational drug study concomitantly or within 30 days prior to entry in the study.
  • Patient is relative of, or staff directly reporting to, the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02242695
Other Study ID Numbers  ICMJE Flu-380112
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medinova AG
Study Sponsor  ICMJE Medinova AG
Collaborators  ICMJE Mahidol University
Investigators  ICMJE
Principal Investigator: Manopchai Thamkhantho, Prof MD Siriraj Gynaecologic ID and Female STD Unit, Mahidol University
PRS Account Medinova AG
Verification Date July 2015

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