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.

Last updated: October 11, 2017
Sponsor: Thinq Pharma-CRO Pte. Ltd.
Overall Status: Trial Status Unknown

Phase

3

Condition

Sexually Transmitted Diseases (Stds)

Fungal Infections

Oral Candidiasis

Treatment

N/A

Clinical Study ID

NCT02635438
TPC-CLT-002
  • Ages 18-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Presence of specific signs and symptoms of Oropharyngeal Candidiasis, includingerythematous 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 onmucosal surfaces).

  3. Confirmation of Candidiasis by findings on direct microscopic examination (potassiumhydroxide smear) consistent with Candida species or positive fungal culture forCandida species, with culture obtained in the 2 days preceding initiation of therapywith the study drug.

  4. Subjects who are able and willing to give Informed Consent.

Exclusion

Exclusion Criteria:

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

  2. Subjects diagnosed with disseminated candidiasis or requiring systemic antifungaltherapy.

  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 azolecompounds) or any constituent of Roxane ® or the generic Clotrimazole Troche/ Lozengesor unable to tolerate oral medication.

  6. Subjects having history of resistance to treatment with clotrimazole (Subject who areresistant to Clotrimazole after culture and sensitivity test have to be excluded fromthe 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 torandomization.

  9. Subjects who have been diagnosed with any concomitant condition that, in the opinionof the investigator, could interfere with the evaluation of efficacy or safety, orwould make it unlikely that the subject would complete the study.

  10. Subjects who have been treated with protease inhibitors for the first time within 30days.

  11. Subjects who have been taking medications known to have significant interaction withazoles (e.g., antacids, H2-receptor blockers, rifampin, phenytoin, carbamazepine,astemizole).

  12. Subjects who have a history of candidal prophylaxis with any azole antifungalmedication.

  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 ofnormal (ULN).

  16. CD4 cell count less than 200 cells/mm3. 17. Absolute neutrophil count less than 500/mm3.

  17. Subject with history of Type II Diabetes Mellitus with Uncontrolled Blood Sugar levels. (I.e. Random Blood Sugar level > 350).

  18. Suspected inability (or) unwillingness to comply with the study procedures.

Study Design

Total Participants: 360
Study Start date:
December 01, 2016
Estimated Completion Date:
November 30, 2018

Study 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.

Connect with a study center

  • Grant Government Medical College & Sir JJ group of Hospital

    Mumbai, Maharashtra 400008
    India

    Active - Recruiting

  • Curie Manavata Cancer Centre

    Nashik, Maharashtra
    India

    Active - Recruiting

  • Manas Hospital

    Nashik, Maharashtra
    India

    Active - Recruiting

  • Gujrat Cancer and Research Institute

    Ahmadabad,
    India

    Active - Recruiting

  • HCG Hospital

    Ahmadabad,
    India

    Site Not Available

  • Sujan Surgical Cancer Hospital & Amravati cancer foundation

    Amravati,
    India

    Active - Recruiting

  • Dr Hedgewar Hospital

    Aurangabad,
    India

    Active - Recruiting

  • Maulana Azad Medical College

    Delhi,
    India

    Site Not Available

  • Bhagwan Mahaveer Cancer Hospital and Research Centre

    Jaipur,
    India

    Active - Recruiting

  • Chittaranjan National Cancer Institute

    Kolkata,
    India

    Active - Recruiting

  • Saroj Gupta Cancer Centre & Research Institute

    Kolkata,
    India

    Active - Recruiting

  • Mandya institute of medical science

    Mandya,
    India

    Active - Recruiting

  • Father Muller Medical College Hospital

    Mangalore,
    India

    Active - Recruiting

  • Tata Memorial Hospital

    Mumbai,
    India

    Site Not Available

  • Government Medical Colllege Nagpur

    Nagpur,
    India

    Active - Recruiting

  • Shree hospital and critical care centre

    Nagpur,
    India

    Active - Recruiting

  • Curie Manavata Cancer Centre

    Nasik,
    India

    Site Not Available

  • Sir Ganga Ram Hospital

    New Delhi,
    India

    Site Not Available

  • Ashwin Medical Foundations Moraya Multispeciality Hospital

    Pune,
    India

    Active - Recruiting

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune,
    India

    Site Not Available

  • P.D.E.AS Ayurved Rugnalaya & Sterling Multispeciality Hospital

    Pune,
    India

    Active - Recruiting

  • Rajiv Gandhi Institute of Medical Science and RIMS Government Hospital

    Srikakulam,
    India

    Active - Recruiting

  • Apple Hospital

    Surat,
    India

    Site Not Available

  • Asian Institute of Medical Science

    Thane,
    India

    Active - Recruiting

  • Kailash cancer hospital and research center

    Vadodara,
    India

    Active - Recruiting

  • Medical College and S.S.G Hospital

    Vadodara,
    India

    Active - Recruiting

  • S.B.K.S. Medical Institute & Research Centre

    Vadodara,
    India

    Active - Recruiting

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