Clinical trial 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.
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 ".
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Oropharyngeal Candidiasis
Keywords: Oropharyngeal Candidiasis
Lead sponsor: Thinq Pharma-CRO Pte. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Unique Pharmaceuticals Ltd, India
name: THINQ Pharma CRO Ltd.
First posted: 2015-12-18
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. Presence of specific signs and symptoms of Oropharyngeal Candidiasis, including erythematous areas, white patches(thrush), mouth pain, irritation, burning, glossitis, altered taste, pruritis, dysphagia and odynophagia.
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:

1. Female subjects who are pregnant, lactating or planning to become pregnant during the study period.
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.

Primary outcomes:
measure: Clinical Cure
timeFrame: 7 days after the end of the therapy, (Day 21(+/- 4)
Secondary outcomes:
measure: Mycological Cure
timeFrame: Day 15(+2) of therapy.
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Grant Government Medical College & Sir JJ group of Hospital
state: Maharashtra
city: Nashik
country: India
facility: Curie Manavata Cancer Centre
state: Maharashtra
city: Nashik
country: India
facility: Manas Hospital
state: Maharashtra
city: Ahmadabad
country: India
facility: Gujrat Cancer and Research Institute
city: Ahmadabad
country: India
facility: HCG Hospital
city: Amravati
country: India
facility: Sujan Surgical Cancer Hospital & Amravati cancer foundation
city: Aurangabad
country: India
facility: Dr Hedgewar Hospital
city: Delhi
country: India
facility: Maulana Azad Medical College
city: Jaipur
country: India
facility: Bhagwan Mahaveer Cancer Hospital and Research Centre
city: Kolkata
country: India
facility: Chittaranjan National Cancer Institute
city: Kolkata
country: India
facility: Saroj Gupta Cancer Centre & Research Institute
city: Mandya
country: India
facility: Mandya institute of medical science
city: Mangalore
country: India
facility: Father Muller Medical College Hospital
city: Mumbai
country: India
facility: Tata Memorial Hospital
city: Nagpur
country: India
facility: Government Medical Colllege Nagpur
city: Nagpur
country: India
facility: Shree hospital and critical care centre
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
city: Pune
country: India
facility: Ashwin Medical Foundations Moraya Multispeciality Hospital
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
city: Pune
country: India
facility: P.D.E.AS Ayurved Rugnalaya & Sterling Multispeciality Hospital
city: Srikakulam
country: India
facility: Rajiv Gandhi Institute of Medical Science and RIMS Government Hospital
city: Surat
country: India
facility: Apple Hospital
city: Thane
country: India
facility: Asian Institute of Medical Science
city: Vadodara
country: India
facility: Kailash cancer hospital and research center
city: Vadodara
country: India
facility: Medical College and S.S.G Hospital
city: Vadodara
country: India
facility: S.B.K.S. Medical Institute & Research Centre
Study officials:
affiliation: Director Medical Services, Unique Pharmacutical Laboratories, India (A Division Of J. B. Chemicals and Pharmacuticals Limited)
name: Shalini Kumar, Medical
role: STUDY_DIRECTOR
References: