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.

Oropharyngeal Candidiasis Clinical Trial

— TPC  

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 ".

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02635438
• Other study ID #: TPC-CLT-002
• Status: Recruiting
• Phase: Phase 3
• First received: December 16, 2015
• Last updated: October 11, 2017
• Start date: December 2016
• Est. completion date: November 2018

Study information

• Verified date: October 2017
• Source: Thinq Pharma-CRO Pte. Ltd.
• Contact: Kalpesh B Vispute, Medical
• Phone: +912225816882
• Email: kalpesh[@]thinqcro.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: November 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Candidiasis
• Oropharyngeal Candidiasis

Intervention

Drug:
• Unique Pharmaceutical Laboratories, India
Clotrimazole troche/ lozenges, 10 mg 5 times a day for 14 consecutive days
• Roxane Laboratories Inc., USA
Clotrimazole Troche/ Lozenges USP, 10 mg 5 times a day for 14 consecutive days

Locations

Country	Name	City	State
India	Gujrat Cancer and Research Institute	Ahmadabad
India	HCG Hospital	Ahmadabad
India	Sujan Surgical Cancer Hospital & Amravati cancer foundation	Amravati
India	Dr Hedgewar Hospital	Aurangabad
India	Maulana Azad Medical College	Delhi
India	Bhagwan Mahaveer Cancer Hospital and Research Centre	Jaipur
India	Chittaranjan National Cancer Institute	Kolkata
India	Saroj Gupta Cancer Centre & Research Institute	Kolkata
India	Mandya institute of medical science	Mandya
India	Father Muller Medical College Hospital	Mangalore
India	Grant Government Medical College & Sir JJ group of Hospital	Mumbai	Maharashtra
India	Tata Memorial Hospital	Mumbai
India	Government Medical Colllege Nagpur	Nagpur
India	Shree hospital and critical care centre	Nagpur
India	Curie Manavata Cancer Centre	Nashik	Maharashtra
India	Manas Hospital	Nashik	Maharashtra
India	Sir Ganga Ram Hospital	New Delhi
India	Ashwin Medical Foundations Moraya Multispeciality Hospital	Pune
India	Deenanath Mangeshkar Hospital and Research Centre	Pune
India	P.D.E.AS Ayurved Rugnalaya & Sterling Multispeciality Hospital	Pune
India	Rajiv Gandhi Institute of Medical Science and RIMS Government Hospital	Srikakulam
India	Apple Hospital	Surat
India	Asian Institute of Medical Science	Thane
India	Kailash cancer hospital and research center	Vadodara
India	Medical College and S.S.G Hospital	Vadodara
India	S.B.K.S. Medical Institute & Research Centre	Vadodara

Sponsors (3)

Lead Sponsor	Collaborator
Thinq Pharma-CRO Pte. Ltd.	THINQ Pharma CRO Ltd., Unique Pharmaceuticals Ltd, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mycological Cure	Mycological cure (negative culture and negative KOH for Candida species) at Day 15(+2) of therapy.	Day 15(+2) of therapy.