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

Information source: Medinova AG
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vulvovaginal Candidiasis

Intervention: Fluomizin vaginal tablets (Drug); Canesten vaginal tablets (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Medinova AG

Official(s) and/or principal investigator(s):
Manopchai Thamkhantho, Prof MD, Principal Investigator, Affiliation: Siriraj Gynaecologic ID and Female STD Unit, Mahidol University

Overall contact:
Manopchai Thamkhanth, Prof MD, Phone: +66 2 419 4775, Email: tmanopchai@hotmail.com

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.

Clinical Details

Official title: Comparative Study of the Efficacy of 10.0 mg Dequalinium Chloride (FluomizinŽ) and 100 mg Clotrimazole (CanestenŽ) for the Treatment of Vulvovaginal Candidiasis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Clinical cure rate

Secondary outcome:

Microbiological cure rate

Therapeutic cure rate

Individual clinical signs and symptoms

Presence of dyspareunia

Direct microscopy (wet smear)

vaginal pH

Candida culture

Global assessment of efficacy

Patient Satisfaction

Adverse event

Global assessment of tolerability

Clinical cure rate

Presence of external dysuria

Microbiological cure rate

Therapeutic cure rate

Individual clinical signs and symptoms

Presence of dyspareunia

Direct microscopy (wet smear)

vaginal pH

Candida culture

Global assessment of efficacy

Patient Satisfaction

Adverse event

Global assessment of tolerability

Presence of external dysuria

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Manopchai Thamkhanth, Prof MD, Phone: +66 2 419 4775, Email: tmanopchai@hotmail.com

Siriraj Gynaecologic ID and Female STD Unit, Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Bangkok Noi district 10700, Thailand; Recruiting
Manopchai Thamkhantho, MD, Phone: +66 2 419 4775, Email: tmanopchai@hotmail.com
Manopchai Thamkhantho, MD, Principal Investigator
Additional Information

Starting date: November 2014
Last updated: July 6, 2015

Page last updated: August 23, 2015

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