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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)

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ClinicalTrials.gov Identifier: NCT02635438
Recruitment Status : Unknown
Verified October 2017 by Thinq Pharma-CRO Pte. Ltd..
Recruitment status was:  Recruiting
First Posted : December 18, 2015
Last Update Posted : October 12, 2017
Sponsor:
Collaborators:
Unique Pharmaceuticals Ltd, India
THINQ Pharma CRO Ltd.
Information provided by (Responsible Party):
Thinq Pharma-CRO Pte. Ltd.

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

Condition or disease Intervention/treatment Phase
Oropharyngeal Candidiasis Drug: Unique Pharmaceutical Laboratories, India Drug: Roxane Laboratories Inc., USA Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 ".
Actual Study Start Date : December 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635438


Contacts
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Contact: Kalpesh B Vispute, Medical +912225816882 ext 882 kalpesh@thinqcro.com
Contact: Nikhil Varma +912225816888 ext 888 nikhil.varma@thinqcro.com

Locations
Show Show 26 study locations
Sponsors and Collaborators
Thinq Pharma-CRO Pte. Ltd.
Unique Pharmaceuticals Ltd, India
THINQ Pharma CRO Ltd.
Investigators
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Study Director: Shalini Kumar, Medical Director Medical Services, Unique Pharmacutical Laboratories, India (A Division Of J. B. Chemicals and Pharmacuticals Limited)
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Responsible Party: Thinq Pharma-CRO Pte. Ltd.
ClinicalTrials.gov Identifier: NCT02635438    
Other Study ID Numbers: TPC-CLT-002
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Keywords provided by Thinq Pharma-CRO Pte. Ltd.:
Oropharyngeal Candidiasis
Additional relevant MeSH terms:
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Candidiasis
Mycoses