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| Name | Class |
|---|---|
| Unique Pharmaceuticals Ltd, India | UNKNOWN |
| THINQ Pharma CRO Ltd. | UNKNOWN |
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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Test Product: Clotrimazole troche/ lozenges USP, 10 mg (Unique Pharmaceutical Laboratories, India) 10mg troche 5 times a day for 14 consecutive days |
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| Arm B | Active Comparator | Reference Product: Clotrimazole Troche/Lozenges ® 10mg (Roxane Laboratories Inc., USA) troche 5 times a day for 14 consecutive days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unique Pharmaceutical Laboratories, India | Drug | Clotrimazole troche/ lozenges, 10 mg 5 times a day for 14 consecutive days |
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| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kalpesh B Vispute, Medical | Contact | +912225816882 | 882 | kalpesh@thinqcro.com |
| Nikhil Varma | Contact | +912225816888 | 888 | nikhil.varma@thinqcro.com |
| Name | Affiliation | Role |
|---|---|---|
| Shalini Kumar, Medical | Director Medical Services, Unique Pharmacutical Laboratories, India (A Division Of J. B. Chemicals and Pharmacuticals Limited) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grant Government Medical College & Sir JJ group of Hospital | Recruiting | Mumbai | Maharashtra | 400008 | India |
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| Roxane Laboratories Inc., USA | Drug | Clotrimazole Troche/ Lozenges USP, 10 mg 5 times a day for 14 consecutive days |
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| Curie Manavata Cancer Centre | Recruiting | Nashik | Maharashtra | India |
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| Manas Hospital | Recruiting | Nashik | Maharashtra | India |
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| Gujrat Cancer and Research Institute | Recruiting | Ahmadābād | India |
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| HCG Hospital | Not yet recruiting | Ahmadābād | India |
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| Sujan Surgical Cancer Hospital & Amravati cancer foundation | Recruiting | Amravati | India |
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| Dr Hedgewar Hospital | Recruiting | Aurangabad | India |
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| Maulana Azad Medical College | Not yet recruiting | Delhi | India |
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| Bhagwan Mahaveer Cancer Hospital and Research Centre | Recruiting | Jaipur | India |
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| Chittaranjan National Cancer Institute | Recruiting | Kolkata | India |
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| Saroj Gupta Cancer Centre & Research Institute | Recruiting | Kolkata | India |
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| Mandya institute of medical science | Recruiting | Mandya | India |
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| Father Muller Medical College Hospital | Recruiting | Mangalore | India |
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| Tata Memorial Hospital | Not yet recruiting | Mumbai | India |
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| Government Medical Colllege Nagpur | Recruiting | Nagpur | India |
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| Shree hospital and critical care centre | Recruiting | Nagpur | India |
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| Sir Ganga Ram Hospital | Not yet recruiting | New Delhi | India |
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| Ashwin Medical Foundations Moraya Multispeciality Hospital | Recruiting | Pune | India |
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| Deenanath Mangeshkar Hospital and Research Centre | Not yet recruiting | Pune | India |
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| P.D.E.AS Ayurved Rugnalaya & Sterling Multispeciality Hospital | Recruiting | Pune | India |
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| Rajiv Gandhi Institute of Medical Science and RIMS Government Hospital | Recruiting | Srikakulam | India |
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| Apple Hospital | Not yet recruiting | Surat | India |
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| Asian Institute of Medical Science | Recruiting | Thane | India |
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| Kailash cancer hospital and research center | Recruiting | Vadodara | India |
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| Medical College and S.S.G Hospital | Recruiting | Vadodara | India |
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| S.B.K.S. Medical Institute & Research Centre | Recruiting | Vadodara | India |
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