Clotrimazole 500 mg Vaginal Tablet Therapeutic Equivalence Clinical Trial

Phase 4

Recruiting

• Conditions: Healthy Adult Females with Vulvovaginal Candidiasis

• Registration Number: CTRI/2013/01/003288
• Lead Sponsor: ACTOR PHARMA PTY LTD

Brief Summary

Thisis a multi-centric, open label, randomized, parallel group, Single DoseClinical Study to Evaluate the Therapeutic Equivalence of Clotrimazole 500 mgVaginal Tablet of Actor Pharma, South Africa.

Thestudy will be conducted at 5 sites in India only.

Approximately100  healthy adult females suffering from Vulvovaginal Candidiasis (50per arm) will be enrolled in the study (Including dropouts/withdrawals). 80completed patients excluding screen failures, drop-outs and withdrawals will beconsidered for data analysis..

Theprimary objective is to evaluate andcompare the therapeutic cure rates defined as clinical cure (resolution ofclinical signs and symptoms) and mycological cure (negative microscopy andnegative culture) at 3±1 days and 14±2 days of Clotrimazole 500 mg VaginalTablet versus Canesten®(Containing Clotrimazole 500 mg) Vaginal Tablet in healthy adult femalessuffering from Vulvovaginal Candidiasis.

.Secondary objective is tomonitor the adverse events and to ensure the safetyof patient.

 The main inclusion criteria for thestudy are Female patients should be of age between 18 to 45 years.and should havea primary diagnosis of Vulvovaginal Candidiasis (VVC).

The test drug used will be Clotrimazole500 mg Vaginal Tablet of Actor Pharma, South Africawhereas the reference drug is Canesten® (Containing Clotrimazole 500mg) Vaginal Tablet of Bayer, South Africa

Enrolledpatients will receive single dose of either test drug or reference drug, thedrug will be administered by inserting one tablet into the vagina (Intra vaginal) at bedtime on Day 0 asper the computer generated randomization sequence.

Durationof Protocol Therapy is 1 day and duration ofpatient participation is approximately 16±2 days [dosing (Day 0) and Follow-upat 3±1 days and 14±2 days after administration of the vaginal tablet.]

Patientsfulfilling inclusion/exclusion criteria at the time of screening would besubjected to medical screening (Day-2). Screening will include, clinicalevaluation and history of medication used in last 1 year. The Patient physical examinationwill be performed including vaginal pH, speculum examination of the vagina, KOHpreparation and it will be evaluated by investigators. A vaginal specimen willbe obtained for culture and susceptibility testing results. Blood and urinesamples will be collected for baseline chemistry, hematology and urinalysistests. All the results from these procedures will be documented in e-CRF. Duringtreatment visit 2 (Day 0) Vital signs, General examination and AE monitoringwill be done on visit 2. Symptoms Relief Card will be filled by investigator.Patient Diary will be provided to patient. All the data from Patient Diary willbe recorded in e-CRF in every visit by the investigator. The follow up visit (post-treatment contact) will be initiated by the investigator at 2, 4, 6 and 8days after the beginning of treatment. The Follow-upVisit 3 & 4 (Test-of-Cure Visit)will start at 3±1 days after post dose,this will be the First Test-of-Cure visit and second Test-of-Cure visit will beat 14±2 days after post dose. At all these visits clinical examination, vaginalexamination and a vaginal semi-quantitative culture will be recorded by theinvestigators. Speciation and susceptibility testing will be done on allpositive cultures.

Primary endpoint  of  the study  is  the proportion  of  patient with  therapeutic  cure, defined  as  both mycological cure and clinical cure, at the test-of-curevisits conducted on study days andSecondaryendpoints will be monitored as safety outcomes. Safety assessments can belimited to local description of toxicity. However, where appreciable systemic absorption occurs, hematology,chemistry, and urine laboratory testing will be performed as per investigatorsdiscretion.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2013-01-22
• Study Start: 2013-07-01

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Female patients aged between 18 to 45 years.
• Patient has a primary diagnosis of Vulvovaginal Candidiasis (VVC).
• Patient willing to give their informed consent.
• Postmenarcheal females with a diagnosis of VVC will be included based on the criteria listed below.
• To be clinically evaluable, Patient should have a clinical diagnosis of VVC based on history and physical examination (including vaginal examination).
• Signs and symptoms to be evaluated include: itching, burning, irritation, edema, erythema and/or excoriation of the vagina/vulva.
• Each evaluated signs and/or symptoms should be given a numerical rating based on severity Documented Papanicolaou (Pap) test at baseline or during the previous 12 months reported as either “negative for intraepithelial lesion or malignancy†or “ASCUS-atypical squamous cells of undetermined significance.†At baseline, ≥ 50% of the patient should have at least moderate severity of VVC, defined as having a minimum composite Vulvovaginal signs and symptoms score of 2.
• Presence of at least one Vulvovaginal symptom (Vulvovaginal itching, burning, or irritation) as assessed by the investigator at baseline.
• Presence of at least one Vulvovaginal sign (Vulvovaginal erythema, edema, or excoriation) as assessed by the investigator at baseline Clinical diagnosis of symptomatic Vulvovaginal Candidiasis (VVC) confirmed at baseline by positive KOH wet mount test (i.e., when examined microscopically, vaginal secretions obtained by swab of the vaginal mucosa, placed on a slide and diluted with 10% room temperature potassium hydroxide (KOH) reveal filamentous hyphae/ pseudohyphae and/or budding yeast cells).

Exclusion Criteria

• Pregnant or nursing women.
• Patient has Menstruation at the time of diagnosis.
• Diabetes mellitus [NOTE: If diabetic women are enrolled, it is important that their diabetes be controlled (Fasting blood glucose should be <200 mg/dl) and the proportion of diabetic patient be similar among all treatment groups, because cure rates might differ in diabetic versus non-diabetic women].
• Insufficiency of liver and/or of kidney (Creatinine > 2.0 mg/dl).
• Use of systemic, topical (applied to the vulva) or vaginal antibiotics, antifungals or anti-trichomonals within 7 days prior to randomization.
• Use of any systemic corticosteroid, immunosuppressive, or immune-stimulating drug within 3 months prior to randomization.
• Presence of concomitant vulvovaginitis caused by other infections (e.g., bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis or Neisseria gonorrhoeae).
• Patient with other infectious causes of vulvovaginitis (e.g., bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex, or human papilloma virus).
• Sexual intercourse 24 hours before the KOH mount test.
• Presence of another vaginal or vulvar condition that would confound the interpretation of clinical response.
• Women who will be under treatment or surgery during the study period for cervical intraepithelial neoplasia (CIN) or cervical carcinoma.
• History of allergy or sensitivity to clotrimazole, related compounds or any component of the formulation.
• HSV-II–Tzanck Smear positive patient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint of the study is the proportion of patient with therapeutic cure, defined as both	Visit 1 (Day -2) | Visit 2 (Day 0) | Visit 3 (Day 3±1) | Visit 4 (Day 14±2)
mycological cure and clinical cure, at the test-of-cure visits conducted on study days	Visit 1 (Day -2) | Visit 2 (Day 0) | Visit 3 (Day 3±1) | Visit 4 (Day 14±2)

Secondary Outcome Measures

Name	Time	Method
The type of AE(s), number of AE(s), frequency of AE(s) and proportion of patients with AE(s).	The severity, seriousness and the relationship of AE to the treatment.

Trial Locations

Locations (5)

Dr. Lads Navjeevan Hospital Pvt. Ltd (Department of gynaecology); 🇮🇳 Nashik, MAHARASHTRA, India

Family Multispeciality Hospital, Nursing Home and Research Centre (Department of gynaecology); 🇮🇳 Nagpur, MAHARASHTRA, India

S.S.Institute of Medical Sciences & Research Centre (Department of gynaecology); 🇮🇳 Davanagere, KARNATAKA, India

Sanjivani Super Speciality Hospital Pvt. Ltd. (Department of gynaecology); 🇮🇳 Ahmadabad, GUJARAT, India

Sharda General Hospital (Department of gynaecology); 🇮🇳 Jaipur, RAJASTHAN, India

Dr. Lads Navjeevan Hospital Pvt. Ltd (Department of gynaecology)

🇮🇳Nashik, MAHARASHTRA, India

Dr Neha Lad

Principal investigator

9225100643

lad.nitin@yahoo.com