The objectives of this study are to compare the efficacy and safety of Clotrimazole troche/ lozenges USP, 10 mg (Unique Pharmaceutical Laboratories, India) vs. Clotrimazole Troche/ Lozenges USP, 10 mg (Roxane Laboratories Inc., USA) in patients with oropharyngeal candidiasis, where this condition has been diagnosed by clinical examination and confirmed by fungal culture
This study is Randomized, Double Blind, Parallel, Comparative study. Approximately 26 study sites across India will participate in this study to complete sample size of 360 randomized subjects in order to achieve at least 250 per-protocol (PP) subjects. Subjects would be assigned randomly to test product or reference product in 1:1 ratio. Subjects with confirmed oral candidiasis by KOH smear/candidal culture will be given study medication 5 times a day for 14 consecutive days. The schedule of the subject's visit at study site will be as follows: 1. Visit 1 - Screening visit (-7 Days). 2. Visit 2 - Randomization (Day 1). 3. Visit 3 - Follow Up (Day 8 (+2)). 4. Visit 4 - Follow Up (Day 15 (+2)). 5. Visit 5 - Follow Up/ End of study (Day 21 (+/-4)) Subjects with complete resolution of signs and symptoms of Oral Candidiasis on Day 21 (+/-4) will be considered as treatment success.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
360
Clotrimazole troche/ lozenges, 10 mg 5 times a day for 14 consecutive days
Clotrimazole Troche/ Lozenges USP, 10 mg 5 times a day for 14 consecutive days
Grant Government Medical College & Sir JJ group of Hospital
Mumbai, Maharashtra, India
RECRUITINGCurie Manavata Cancer Centre
Nashik, Maharashtra, India
RECRUITINGManas Hospital
Nashik, Maharashtra, India
RECRUITINGGujrat Cancer and Research Institute
Ahmadābād, India
RECRUITINGHCG Hospital
Ahmadābād, India
NOT_YET_RECRUITINGSujan Surgical Cancer Hospital & Amravati cancer foundation
Amravati, India
RECRUITINGDr Hedgewar Hospital
Aurangabad, India
RECRUITINGMaulana Azad Medical College
Delhi, India
NOT_YET_RECRUITINGBhagwan Mahaveer Cancer Hospital and Research Centre
Jaipur, India
RECRUITINGChittaranjan National Cancer Institute
Kolkata, India
RECRUITING...and 16 more locations
Clinical Cure
Clinical cure i.e., complete resolution of all signs and symptoms of Oropharyngeal Candidiasis, 7 days after the end of the therapy, (Day 21(+/- 4)). Signs and Symptoms of Oral Candidiasis will be assessed using the Murray scale on day 21(+/- 4). According to the Murray Scale, lesion score 0 and symptom score 0 is considered as clinical cure.
Time frame: 7 days after the end of the therapy, (Day 21(+/- 4)
Mycological Cure
Mycological cure (negative culture and negative KOH for Candida species) at Day 15(+2) of therapy.
Time frame: Day 15(+2) of therapy.
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