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. (TPC)
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|ClinicalTrials.gov Identifier: NCT02635438|
Recruitment Status : Unknown
Verified October 2017 by Thinq Pharma-CRO Pte. Ltd..
Recruitment status was: Recruiting
First Posted : December 18, 2015
Last Update Posted : October 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Oropharyngeal Candidiasis||Drug: Unique Pharmaceutical Laboratories, India Drug: Roxane Laboratories Inc., USA||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||"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 ".|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||November 2018|
Experimental: Arm A
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
Clotrimazole troche/ lozenges, 10 mg 5 times a day for 14 consecutive days
Active Comparator: Arm B
Reference Product: Clotrimazole Troche/Lozenges ® 10mg (Roxane Laboratories Inc., USA) troche 5 times a day for 14 consecutive days
Drug: Roxane Laboratories Inc., USA
Clotrimazole Troche/ Lozenges USP, 10 mg 5 times a day for 14 consecutive days
- Clinical Cure [ Time Frame: 7 days after the end of the therapy, (Day 21(+/- 4) ]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.
- Mycological Cure [ Time Frame: Day 15(+2) of therapy. ]Mycological cure (negative culture and negative KOH for Candida species) at Day 15(+2) of therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635438
|Contact: Kalpesh B Vispute, Medical||+912225816882 ext email@example.com|
|Contact: Nikhil Varma||+912225816888 ext firstname.lastname@example.org|
|Study Director:||Shalini Kumar, Medical||Director Medical Services, Unique Pharmacutical Laboratories, India (A Division Of J. B. Chemicals and Pharmacuticals Limited)|