A Comparative Clinical Trial to Evaluate the Safety and Clinical Equivalence of Clotrimazole Troche/Lozenges USP, 10mg (Unique Pharmaceutical Laboratories, India) With Clotrimazole Troche 10mg (Roxane Laboratories Inc., USA) in Subjects With Oropharyngeal Candidiasis.

Study Overview
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Brief Summary
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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

Detailed Description
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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: Visit 1 - Screening visit (-7 Days). Visit 2 - Randomization (Day 1). Visit 3 - Follow Up (Day 8 (+2)). Visit 4 - Follow Up (Day 15 (+2)). 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.

Official Title
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A Multi-Centre, Randomized, Double Blind, Parallel-Group, Comparative Clinical Trial to Evaluate the Safety and Clinical Equivalence of Generic Clotrimazole Troche/Lozenges USP, 10mg (Unique Pharmaceutical Laboratories, India) to Clotrimazole Troche/Lozenges ® 10mg (Roxane Laboratories Inc., USA) in Subjects With Oropharyngeal Candidiasis .

Conditions
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Oropharyngeal Candidiasis

Intervention / Treatment
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* Drug: Unique Pharmaceutical Laboratories, India
* Drug: Roxane Laboratories Inc., USA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of specific signs and symptoms of Oropharyngeal Candidiasis, including erythematous 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 on mucosal surfaces). Confirmation of Candidiasis by findings on direct microscopic examination (potassium hydroxide smear) consistent with Candida species or positive fungal culture for Candida species, with culture obtained in the 2 days preceding initiation of therapy with the study drug. Subjects who are able and willing to give Informed Consent. Exclusion Criteria: Female subjects who are pregnant, lactating or planning to become pregnant during the study period. Subjects diagnosed with disseminated candidiasis or requiring systemic antifungal therapy. 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 azole compounds) or any constituent of Roxane ® or the generic Clotrimazole Troche/ Lozenges or unable to tolerate oral medication. Subjects having history of resistance to treatment with clotrimazole (Subject who are resistant to Clotrimazole after culture and sensitivity test have to be excluded from the 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 to randomization. Subjects who have been diagnosed with any concomitant condition that, in the opinion of the investigator, could interfere with the evaluation of efficacy or safety, or would make it unlikely that the subject would complete the study. Subjects who have been treated with protease inhibitors for the first time within 30 days. Subjects who have been taking medications known to have significant interaction with azoles (e.g., antacids, H2-receptor blockers, rifampin, phenytoin, carbamazepine, astemizole). Subjects who have a history of candidal prophylaxis with any azole antifungal medication. 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 of normal (ULN). CD4 cell count less than 200 cells/mm3. 17. Absolute neutrophil count less than 500/mm3. 18. Subject with history of Type II Diabetes Mellitus with Uncontrolled Blood Sugar levels. (I.e. Random Blood Sugar level > 350). 19. Suspected inability (or) unwillingness to comply with the study procedures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Test Product: Clotrimazole troche/ lozenges USP, 10 mg (Unique Pharmaceutical Laboratories, India) 10mg troche 5 times a day for 14 consecutive days | Drug: Unique Pharmaceutical Laboratories, India<br>* Clotrimazole troche/ lozenges, 10 mg 5 times a day for 14 consecutive days<br>|
| Active Comparator: Arm B<br>Reference Product: Clotrimazole Troche/Lozenges ® 10mg (Roxane Laboratories Inc., USA) troche 5 times a day for 14 consecutive days | Drug: Roxane Laboratories Inc., USA<br>* Clotrimazole Troche/ Lozenges USP, 10 mg 5 times a day for 14 consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days after the end of the therapy, (Day 21(+/- 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mycological Cure | Mycological cure (negative culture and negative KOH for Candida species) at Day 15(+2) of therapy. | Day 15(+2) of therapy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oropharyngeal Candidiasis