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.

NCT02635438 | Unknown Phase 3

• 1 other identifier: TPC-CLT-002
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 26

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

Conditions

Oropharyngeal Candidiasis

Keywords

Oropharyngeal Candidiasis

Outcome Measures

Primary Outcomes (1)

• Clinical Cure

  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 Outcomes (1)

• Mycological Cure

  Day 15(+2) of therapy.

Study Arms (2)

Arm A

EXPERIMENTAL

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

Arm B

ACTIVE COMPARATOR

Reference Product: Clotrimazole Troche/Lozenges ® 10mg (Roxane Laboratories Inc., USA) troche 5 times a day for 14 consecutive days

Drug: Roxane Laboratories Inc., USA

Interventions

Unique Pharmaceutical Laboratories, India DRUG

Clotrimazole troche/ lozenges, 10 mg 5 times a day for 14 consecutive days

Arm A

Roxane Laboratories Inc., USA DRUG

Clotrimazole Troche/ Lozenges USP, 10 mg 5 times a day for 14 consecutive days

Arm B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• 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.
• Subjects who are able and willing to give Informed Consent.

You may not qualify if:

• Female subjects who are pregnant, lactating or planning to become pregnant during the study period.
• Subjects diagnosed with disseminated candidiasis or requiring systemic antifungal therapy.
• Subjects diagnosed with hairy leukoplakia.
• Presence of only perioral lesions, e.g., angular chelitis.
• 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.
• 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).
• Subjects who have received any oral or systemic antifungal therapy within fourteen (14) days prior to randomization.
• Subjects who have received any investigational therapy within 30 days prior to randomization.
• 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.
• Subjects who have been treated with protease inhibitors for the first time within 30 days.
• Subjects who have been taking medications known to have significant interaction with azoles (e.g., antacids, H2-receptor blockers, rifampin, phenytoin, carbamazepine, astemizole).
• Subjects who have a history of candidal prophylaxis with any azole antifungal medication.
• Any subject with recurrent Oropharyngeal Candidiasis.
• Any subject who is chronically infected with Candida.
• Any subject with baseline liver function tests greater than 3 times the upper limit of normal (ULN).

Sponsors & Collaborators

• Thinq Pharma-CRO Pte. Ltd.: lead
• Unique Pharmaceuticals Ltd, India: collaborator
• THINQ Pharma CRO Ltd.: collaborator

Study Sites (26)

Grant Government Medical College & Sir JJ group of Hospital

Mumbai, Maharashtra, 400008, India

RECRUITING

Curie Manavata Cancer Centre

Nashik, Maharashtra, India

RECRUITING

Manas Hospital

Nashik, Maharashtra, India

RECRUITING

Gujrat Cancer and Research Institute

Ahmadābād, India

RECRUITING

HCG Hospital

Ahmadābād, India

NOT YET RECRUITING

Sujan Surgical Cancer Hospital & Amravati cancer foundation

Amravati, India

RECRUITING

Dr Hedgewar Hospital

Aurangabad, India

RECRUITING

Maulana Azad Medical College

Delhi, India

NOT YET RECRUITING

Bhagwan Mahaveer Cancer Hospital and Research Centre

Jaipur, India

RECRUITING

Chittaranjan National Cancer Institute

Kolkata, India

RECRUITING

Saroj Gupta Cancer Centre & Research Institute

Kolkata, India

RECRUITING

Mandya institute of medical science

Mandya, India

RECRUITING

Father Muller Medical College Hospital

Mangalore, India

RECRUITING

Tata Memorial Hospital

Mumbai, India

NOT YET RECRUITING

Government Medical Colllege Nagpur

Nagpur, India

RECRUITING

Shree hospital and critical care centre

Nagpur, India

RECRUITING

Sir Ganga Ram Hospital

New Delhi, India

NOT YET RECRUITING

Ashwin Medical Foundations Moraya Multispeciality Hospital

Pune, India

RECRUITING

Deenanath Mangeshkar Hospital and Research Centre

Pune, India

NOT YET RECRUITING

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

Pune, India

RECRUITING

Rajiv Gandhi Institute of Medical Science and RIMS Government Hospital

Srikakulam, India

RECRUITING

Apple Hospital

Surat, India

NOT YET RECRUITING

Asian Institute of Medical Science

Thane, India

RECRUITING

Kailash cancer hospital and research center

Vadodara, India

RECRUITING

Medical College and S.S.G Hospital

Vadodara, India

RECRUITING

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

Vadodara, India

RECRUITING

Study Officials

• Shalini Kumar, Medical

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

  STUDY DIRECTOR

Central Study Contacts

Kalpesh B Vispute, Medical

CONTACT

+912225816882; kalpesh@thinqcro.com

Nikhil Varma

CONTACT

+912225816888; nikhil.varma@thinqcro.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 18, 2015
• Study Start: December 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: November 1, 2018
• Last Updated: October 12, 2017

Record last verified: 2017-10

Locations

IN (26)