Clinical Trial: 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 Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Pha

Brief 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 Summary:

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.

Sponsor: Thinq Pharma-CRO Pte. Ltd.

Current Primary Outcome: 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.


Original Primary Outcome: 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.


Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Thinq Pharma-CRO Pte. Ltd.

Dates:
Date Received: December 16, 2015
Date Started: December 2016
Date Completion: July 2017
Last Updated: December 22, 2016
Last Verified: December 2016