A Comparative Clinical trial to evaluate the Safety and Clinical Equivalence of Clotrimazole Troche/Lozenges USP, 10mg (manufactured by Unique Pharmaceutical Laboratories, India) with Clotrimazole Troche 10mg (Roxane Laboratories Inc., USA) in subjects with Oropharyngeal Candidiasis.
- Conditions
- Oropharyngeal Candidiasis
- Registration Number
- CTRI/2016/01/006515
- Lead Sponsor
- THINQ Pharma CRO Private Limited
- Brief Summary
**Study 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 (manufactured by Unique Pharmaceutical Laboratories, India) to Clotrimazole Troche/Lozenges ® 10mg (Roxane Laboratories Inc., USA) in subjects with Oropharyngeal Candidiasis**
**Study Rationale: - Oropharyngeal Candidiasis is a mycosis (yeast/fungal infection) of Candida species on the mucous membranes of the mouth. Clotrimazole is a broad-spectrum antifungal agent which is fungistatic and fungicidal and has not shown any serious adverse events. Topical drugs show increased bioavailability. By administration of a topical alternative, the affected area can be treated directly in a manner which greatly minimizes the adverse effects associated with oral medications. Hence, topical alternative minimizes the adverse events. Clotrimazole troche persists in the saliva at sufficient concentration for around 3 hours. This long term persistence of drug in saliva appears to be related to the slow release of clotrimazole from the oral mucosa to which the drug is apparently bound. Also, given as a troche, it may be the best choice nowadays owing to its high clinical success rate, safety, cost effectiveness, and high subject acceptability.**
**Primary Objective is to evaluate the 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)), which will be assessed using the Murray scale. According to the Murray Scale, lesion score 0 (0=none, 1=single, localized, 2=multiple, localized, 3=extensive, confluent) and symptom score 0 (0=absent, 1=mild, 2=moderate, 3=severe) will be considered as clinical cure**
**Secondary Objective is to assess the mycological cure (negative culture and negative KOH for Candida species) and complete resolution of all signs and symptoms of Oropharyngeal Candidiasis at Day 15(+2).**
**Sample Size: - 360 randomized, completed subjects in order to achieve at least 250 per-protocol (PP) subjects.**
**Study Design: - A Multi-Centre, Randomized, Double Blind, Parallel-Group, Comparative Clinical Trial. The subjects would be assigned to test product and reference product in the ratio of 1:1.**
**Arm A: Test Product: Clotrimazole troche/ lozenges USP, 10 mg (Unique Pharmaceutical Laboratories, India)**
**Arm B: Reference Product: Clotrimazole Troche/ Lozenges USP, 10 mg (Roxane Laboratories Inc., USA)**
**Duration of the Clinical Trial:- Total duration of the study will be approximately 5 months. After Randomization, the treatment will be for 14 consecutive days, and follow-up will be conducted on Day 8(+2), Day 15(+2) and Day 21(+4).**
**Statistical analysis: - Continuous data will be described using Mean, Standard Deviation, Median, Minimum and Maximum values. Categorical data will be described using counts and percentages. P value less than 0.05 will be considered as statistically significant.**
**The Per-Protocol population (PP) will include all randomized subjects who met all inclusion/exclusion criteria, had a positive baseline Candida culture, complied with minimum treatment course, returned to study site for primary end point assessment visit (Day 21 (± 4)) or discontinued from the study as treatment failure and did not have any protocol violations. This PP population will be used for efficacy analysis.**
**Efficacy: The efficacy evaluation will be calculated based on the primary and secondary endpoints of the study.**
**Safety: Safety will be evaluated by assessing laboratory parameters on visit 1 and visit 5 which includes (CBC, BSL (R), Blood urea and Serum creatinine) & LFT [T.Bil, ALKP, SGPT & SGOT]. Vital signs will be measured at all visits and will be used for safety assessment. Safety parameters will also be assessed by adverse event monitoring throughout the study.**
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 360
- 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.
- 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 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.
- CD4 cell count less than 200 cells/mm3.
- Absolute neutrophil count less than 500/mm3.
- Subject with history of Type II Diabetes Mellitus with Uncontrolled Blood Sugar levels.
- (I.e. Random Blood Sugar level > 350).
- Suspected inability (or) unwillingness to comply with the study procedures.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical cure i.e., complete resolution of all signs and symptoms of Oropharyngeal Candidiasis Day 17-25
- Secondary Outcome Measures
Name Time Method Mycological cure (negative culture and negative KOH for Candida species) Day 15-17
Trial Locations
- Locations (28)
Apple Hospital
🇮🇳Surat, GUJARAT, India
Ashwin Medical Foundations Moraya Multispeciality Hospital
🇮🇳Pune, MAHARASHTRA, India
Asian Institute of Medical Sciences
🇮🇳Thane, MAHARASHTRA, India
Bhagwan Mahaveer Cancer Hospital and Research Centre
🇮🇳Jaipur, RAJASTHAN, India
Chittaranjan National Cancer Institute
🇮🇳Kolkata, WEST BENGAL, India
Curie Manavata Cancer Centre
🇮🇳Nashik, MAHARASHTRA, India
Deenanath Mangeshkar Hospital and Research Centre
🇮🇳Pune, MAHARASHTRA, India
Dr Hedgewar Hospital
🇮🇳Aurangabad, MAHARASHTRA, India
Father Muller Medical College Hospital
🇮🇳Kannada, KARNATAKA, India
Government Medical Colllege Nagpur
🇮🇳Nagpur, MAHARASHTRA, India
Scroll for more (18 remaining)Apple Hospital🇮🇳Surat, GUJARAT, IndiaDr Ghanshyam N PatelPrincipal investigator91-9376913131drgnpatelonco@gmail.com