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)

October 11, 2017 updated by: Thinq Pharma-CRO Pte. Ltd.

"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 ".

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Ahmadabad, India
        • Recruiting
        • Gujrat Cancer and Research Institute
        • Contact:
        • Principal Investigator:
          • Dr. Geeta Joshi
      • Ahmadabad, India
        • Not yet recruiting
        • HCG Hospital
        • Contact:
        • Principal Investigator:
          • Dr. Shamik Mehta
      • Amravati, India
        • Recruiting
        • Sujan Surgical Cancer Hospital & Amravati Cancer Foundation
        • Contact:
        • Principal Investigator:
          • Dr. Dwarakadas Adwani
      • Aurangabad, India
        • Recruiting
        • Dr Hedgewar Hospital
        • Contact:
        • Principal Investigator:
          • Dr. Venkatesh Deshpande
      • Delhi, India
        • Not yet recruiting
        • Maulana Azad Medical College
        • Contact:
        • Principal Investigator:
          • Dr. Ravi Meher
      • Jaipur, India
        • Recruiting
        • Bhagwan Mahaveer Cancer Hospital and Research Centre
        • Contact:
        • Principal Investigator:
          • Dr. Tej Prakash Soni
      • Kolkata, India
        • Recruiting
        • Chittaranjan National Cancer Institute
        • Contact:
        • Principal Investigator:
          • Dr. K K Mukherjee
      • Kolkata, India
        • Recruiting
        • Saroj Gupta Cancer Centre & Research Institute
        • Contact:
        • Principal Investigator:
          • Dr. Dhrubajyoti Mukhopadhyay
      • Mandya, India
        • Recruiting
        • Mandya institute of medical science
        • Contact:
        • Principal Investigator:
          • Dr. Hanumanth Prasad
      • Mangalore, India
        • Recruiting
        • Father Muller Medical College Hospital
        • Contact:
        • Principal Investigator:
          • Dr. Savita Lasrado
      • Mumbai, India
        • Not yet recruiting
        • Tata Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Dr. Devendra Chaukar
      • Nagpur, India
        • Recruiting
        • Government Medical Colllege Nagpur
        • Contact:
        • Principal Investigator:
          • Dr. Kalpana Dasgupta
      • Nagpur, India
        • Recruiting
        • Shree Hospital And Critical Care Centre
        • Contact:
        • Principal Investigator:
          • Dr. Ashish Chikhale
      • New Delhi, India
        • Not yet recruiting
        • Sir Ganga Ram Hospital
        • Contact:
        • Principal Investigator:
          • Dr. Ajay Swaroop
      • Pune, India
        • Recruiting
        • Ashwin Medical Foundations Moraya Multispeciality Hospital
        • Contact:
        • Principal Investigator:
          • Dr. Ravindra Kulkarni
      • Pune, India
        • Not yet recruiting
        • Deenanath Mangeshkar Hospital And Research Centre
        • Contact:
        • Principal Investigator:
          • Dr. Bharat Purandare
      • Pune, India
        • Recruiting
        • P.D.E.AS Ayurved Rugnalaya & Sterling Multispeciality Hospital
        • Contact:
        • Principal Investigator:
          • Dr. Rakesh Nave
      • Srikakulam, India
        • Recruiting
        • Rajiv Gandhi Institute of Medical Science and RIMS Government Hospital
        • Contact:
        • Principal Investigator:
          • Dr. BLN Prasad
      • Surat, India
        • Not yet recruiting
        • Apple Hospital
        • Contact:
        • Principal Investigator:
          • Dr. Ghanshyam N Patel
      • Thane, India
        • Recruiting
        • Asian Institute Of Medical Science
        • Contact:
        • Principal Investigator:
          • Dr. Neha Pangam
      • Vadodara, India
        • Recruiting
        • Kailash Cancer Hospital and Research Center
        • Contact:
        • Principal Investigator:
          • Dr. Shehnaz Kanthariya
      • Vadodara, India
        • Recruiting
        • Medical College and S.S.G Hospital
        • Contact:
        • Principal Investigator:
          • Dr. Vimal Batra
      • Vadodara, India
        • Recruiting
        • S.B.K.S. Medical Institute & Research Centre
        • Contact:
        • Principal Investigator:
          • Dr. Ajay George
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • Recruiting
        • Grant Government Medical College & Sir JJ group of Hospital
        • Contact:
        • Principal Investigator:
          • Dr. Mohan Jagade
      • Nashik, Maharashtra, India
        • Recruiting
        • Curie Manavata Cancer Centre
        • Contact:
        • Principal Investigator:
          • Dr. Suwarna Tambade
      • Nashik, Maharashtra, India
        • Recruiting
        • Manas Hospital
        • Contact:
        • Principal Investigator:
          • Dr. Bhushan Nemade

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days after the end of the therapy, (Day 21(+/- 4)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 15(+2) of therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thinq Pharma-CRO Pte. Ltd.

Collaborators

Unique Pharmaceuticals Ltd, India
THINQ Pharma CRO Ltd.

Investigators

  • Study Director: Shalini Kumar, Medical, Director Medical Services, Unique Pharmacutical Laboratories, India (A Division Of J. B. Chemicals and Pharmacuticals Limited)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2018

Study Completion (ANTICIPATED)

November 1, 2018

Study Registration Dates

First Submitted

December 16, 2015

First Submitted That Met QC Criteria

December 16, 2015

First Posted (ESTIMATE)

December 18, 2015

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPC-CLT-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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