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.
NCT ID: NCT02635438
Last Updated: 2017-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
360 participants
INTERVENTIONAL
2016-12-31
2018-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm A
Test Product: Clotrimazole troche/ lozenges USP, 10 mg (Unique Pharmaceutical Laboratories, India) 10mg troche 5 times a day for 14 consecutive days
Unique Pharmaceutical Laboratories, India
Clotrimazole troche/ lozenges, 10 mg 5 times a day for 14 consecutive days
Arm B
Reference Product: Clotrimazole Troche/Lozenges ® 10mg (Roxane Laboratories Inc., USA) troche 5 times a day for 14 consecutive days
Roxane Laboratories Inc., USA
Clotrimazole Troche/ Lozenges USP, 10 mg 5 times a day for 14 consecutive days
Interventions
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Unique Pharmaceutical Laboratories, India
Clotrimazole troche/ lozenges, 10 mg 5 times a day for 14 consecutive days
Roxane Laboratories Inc., USA
Clotrimazole Troche/ Lozenges USP, 10 mg 5 times a day for 14 consecutive days
Eligibility Criteria
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Inclusion Criteria
2. 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).
3. 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.
4. Subjects who are able and willing to give Informed Consent.
Exclusion Criteria
2. Subjects diagnosed with disseminated candidiasis or requiring systemic antifungal therapy.
3. Subjects diagnosed with hairy leukoplakia.
4. Presence of only perioral lesions, e.g., angular chelitis.
5. 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.
6. 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).
7. Subjects who have received any oral or systemic antifungal therapy within fourteen (14) days prior to randomization.
8. Subjects who have received any investigational therapy within 30 days prior to randomization.
9. 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.
10. Subjects who have been treated with protease inhibitors for the first time within 30 days.
11. Subjects who have been taking medications known to have significant interaction with azoles (e.g., antacids, H2-receptor blockers, rifampin, phenytoin, carbamazepine, astemizole).
12. Subjects who have a history of candidal prophylaxis with any azole antifungal medication.
13. Any subject with recurrent Oropharyngeal Candidiasis.
14. Any subject who is chronically infected with Candida.
15. Any subject with baseline liver function tests greater than 3 times the upper limit of normal (ULN).
16. 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.
18 Years
65 Years
ALL
No
Sponsors
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Unique Pharmaceuticals Ltd, India
UNKNOWN
THINQ Pharma CRO Ltd.
UNKNOWN
Thinq Pharma-CRO Pte. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Shalini Kumar, Medical
Role: STUDY_DIRECTOR
Director Medical Services, Unique Pharmacutical Laboratories, India (A Division Of J. B. Chemicals and Pharmacuticals Limited)
Locations
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Grant Government Medical College & Sir JJ group of Hospital
Mumbai, Maharashtra, India
Curie Manavata Cancer Centre
Nashik, Maharashtra, India
Manas Hospital
Nashik, Maharashtra, India
Gujrat Cancer and Research Institute
Ahmadābād, , India
HCG Hospital
Ahmadābād, , India
Sujan Surgical Cancer Hospital & Amravati cancer foundation
Amravati, , India
Dr Hedgewar Hospital
Aurangabad, , India
Maulana Azad Medical College
Delhi, , India
Bhagwan Mahaveer Cancer Hospital and Research Centre
Jaipur, , India
Chittaranjan National Cancer Institute
Kolkata, , India
Saroj Gupta Cancer Centre & Research Institute
Kolkata, , India
Mandya institute of medical science
Mandya, , India
Father Muller Medical College Hospital
Mangalore, , India
Tata Memorial Hospital
Mumbai, , India
Government Medical Colllege Nagpur
Nagpur, , India
Shree hospital and critical care centre
Nagpur, , India
Sir Ganga Ram Hospital
New Delhi, , India
Ashwin Medical Foundations Moraya Multispeciality Hospital
Pune, , India
Deenanath Mangeshkar Hospital and Research Centre
Pune, , India
P.D.E.AS Ayurved Rugnalaya & Sterling Multispeciality Hospital
Pune, , India
Rajiv Gandhi Institute of Medical Science and RIMS Government Hospital
Srikakulam, , India
Apple Hospital
Surat, , India
Asian Institute of Medical Science
Thāne, , India
Kailash cancer hospital and research center
Vadodara, , India
Medical College and S.S.G Hospital
Vadodara, , India
S.B.K.S. Medical Institute & Research Centre
Vadodara, , India
Countries
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Central Contacts
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Facility Contacts
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Dr. Mohan Jagade
Role: primary
Dr. Suwarna Tambade
Role: primary
Dr. Bhushan Nemade
Role: primary
Dr. Geeta Joshi
Role: primary
Dr. Shamik Mehta
Role: primary
Dr. Dwarakadas Adwani
Role: primary
Dr. Venkatesh Deshpande
Role: primary
Dr. Ravi Meher
Role: primary
Dr. Tej Prakash Soni
Role: primary
Dr. K K Mukherjee
Role: primary
Dr. Dhrubajyoti Mukhopadhyay
Role: primary
Dr. Hanumanth Prasad
Role: primary
Dr. Savita Lasrado
Role: primary
Dr. Devendra Chaukar
Role: primary
Dr. Kalpana Dasgupta
Role: primary
Dr. Ashish Chikhale
Role: primary
Dr. Ajay Swaroop
Role: primary
Dr. Ravindra Kulkarni
Role: primary
Dr. Bharat Purandare
Role: primary
Dr. Rakesh Neve
Role: primary
Dr. BLN Prasad
Role: primary
Dr. Ghanshyam N Patel
Role: primary
Dr. Neha Pangam
Role: primary
Dr. Shehnaz Kanthariya
Role: primary
Dr. Vimal Batra
Role: primary
Dr. Ajay George
Role: primary
Other Identifiers
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TPC-CLT-002
Identifier Type: -
Identifier Source: org_study_id