Phase
Condition
Sexually Transmitted Diseases (Stds)
Fungal Infections
Oral Candidiasis
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Presence of specific signs and symptoms of Oropharyngeal Candidiasis, includingerythematous areas, white patches(thrush), mouth pain, irritation, burning, glossitis,altered taste, pruritis, dysphagia and odynophagia.
Clinical examination of oropharynx consistent with a diagnosis of oral candidiasis (such as creamy, white, curd-like patches of "thrush" or erythematous lesions onmucosal surfaces).
Confirmation of Candidiasis by findings on direct microscopic examination (potassiumhydroxide smear) consistent with Candida species or positive fungal culture forCandida species, with culture obtained in the 2 days preceding initiation of therapywith the study drug.
Subjects who are able and willing to give Informed Consent.
Exclusion
Exclusion Criteria:
Female subjects who are pregnant, lactating or planning to become pregnant during thestudy period.
Subjects diagnosed with disseminated candidiasis or requiring systemic antifungaltherapy.
Subjects diagnosed with hairy leukoplakia.
Presence of only perioral lesions, e.g., angular chelitis.
History of intolerance or sensitivity to clotrimazole (or other imidazole or azolecompounds) or any constituent of Roxane ® or the generic Clotrimazole Troche/ Lozengesor unable to tolerate oral medication.
Subjects having history of resistance to treatment with clotrimazole (Subject who areresistant to Clotrimazole after culture and sensitivity test have to be excluded fromthe study).
Subjects who have received any oral or systemic antifungal therapy within fourteen (14) days prior to randomization.
Subjects who have received any investigational therapy within 30 days prior torandomization.
Subjects who have been diagnosed with any concomitant condition that, in the opinionof the investigator, could interfere with the evaluation of efficacy or safety, orwould make it unlikely that the subject would complete the study.
Subjects who have been treated with protease inhibitors for the first time within 30days.
Subjects who have been taking medications known to have significant interaction withazoles (e.g., antacids, H2-receptor blockers, rifampin, phenytoin, carbamazepine,astemizole).
Subjects who have a history of candidal prophylaxis with any azole antifungalmedication.
Any subject with recurrent Oropharyngeal Candidiasis.
Any subject who is chronically infected with Candida.
Any subject with baseline liver function tests greater than 3 times the upper limit ofnormal (ULN).
CD4 cell count less than 200 cells/mm3. 17. Absolute neutrophil count less than 500/mm3.
Subject with history of Type II Diabetes Mellitus with Uncontrolled Blood Sugar levels. (I.e. Random Blood Sugar level > 350).
Suspected inability (or) unwillingness to comply with the study procedures.
Study Design
Study Description
Connect with a study center
Grant Government Medical College & Sir JJ group of Hospital
Mumbai, Maharashtra 400008
IndiaActive - Recruiting
Curie Manavata Cancer Centre
Nashik, Maharashtra
IndiaActive - Recruiting
Manas Hospital
Nashik, Maharashtra
IndiaActive - Recruiting
Gujrat Cancer and Research Institute
Ahmadabad,
IndiaActive - Recruiting
HCG Hospital
Ahmadabad,
IndiaSite Not Available
Sujan Surgical Cancer Hospital & Amravati cancer foundation
Amravati,
IndiaActive - Recruiting
Dr Hedgewar Hospital
Aurangabad,
IndiaActive - Recruiting
Maulana Azad Medical College
Delhi,
IndiaSite Not Available
Bhagwan Mahaveer Cancer Hospital and Research Centre
Jaipur,
IndiaActive - Recruiting
Chittaranjan National Cancer Institute
Kolkata,
IndiaActive - Recruiting
Saroj Gupta Cancer Centre & Research Institute
Kolkata,
IndiaActive - Recruiting
Mandya institute of medical science
Mandya,
IndiaActive - Recruiting
Father Muller Medical College Hospital
Mangalore,
IndiaActive - Recruiting
Tata Memorial Hospital
Mumbai,
IndiaSite Not Available
Government Medical Colllege Nagpur
Nagpur,
IndiaActive - Recruiting
Shree hospital and critical care centre
Nagpur,
IndiaActive - Recruiting
Curie Manavata Cancer Centre
Nasik,
IndiaSite Not Available
Sir Ganga Ram Hospital
New Delhi,
IndiaSite Not Available
Ashwin Medical Foundations Moraya Multispeciality Hospital
Pune,
IndiaActive - Recruiting
Deenanath Mangeshkar Hospital and Research Centre
Pune,
IndiaSite Not Available
P.D.E.AS Ayurved Rugnalaya & Sterling Multispeciality Hospital
Pune,
IndiaActive - Recruiting
Rajiv Gandhi Institute of Medical Science and RIMS Government Hospital
Srikakulam,
IndiaActive - Recruiting
Apple Hospital
Surat,
IndiaSite Not Available
Asian Institute of Medical Science
Thane,
IndiaActive - Recruiting
Kailash cancer hospital and research center
Vadodara,
IndiaActive - Recruiting
Medical College and S.S.G Hospital
Vadodara,
IndiaActive - Recruiting
S.B.K.S. Medical Institute & Research Centre
Vadodara,
IndiaActive - Recruiting
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