NCT02635438

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.

"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 ".

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Thinq Pharma-CRO Pte. Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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: 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

• Oropharyngeal Candidiasis

Interventions

Type	Name	Description
DRUG	Unique Pharmaceutical Laboratories, India	Clotrimazole troche/ lozenges, 10 mg 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

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-09-01
• Completion: 2018-11-01
• First posted: 2015-12-18
• Last updated: 2017-10-12

Locations

26 sites across 1 country: India