Oropharyngeal CandidiasisPhase 3TPCNCT02635438
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.
A Phase 3 study testing Unique Pharmaceutical Laboratories, India and Roxane Laboratories Inc., USA in people with Oropharyngeal Candidiasis, run by Thinq Pharma-CRO Pte. Ltd. at 26 sites in India.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Oropharyngeal Candidiasis
- What is being tested?
- Unique Pharmaceutical Laboratories, India and Roxane Laboratories Inc., USA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 26 sitesIndia
- Study dates
- Dec 2016to Nov 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 18Show fewer
- 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).
- 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.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
India26 sites, 26 recruiting
- Recruiting
Gujrat Cancer and Research Institute
Ahmadābād
Dr. Geeta Joshi, 91-9824075707, dr.geetajoshi@gmail.com
Dr. Geeta Joshi
- Not yet recruiting
HCG Hospital
Ahmadābād
Dr. Shamik Mehta, 91-9879090765, mehta.shamik@gmail.com
Dr. Shamik Mehta
- Recruiting
Sujan Surgical Cancer Hospital & Amravati cancer foundation
Amravati
Dr. Dwarakadas Adwani, 91-9823288672, dr.dgadwani1@gmail.com
Dr. Dwarakadas Adwani
- Recruiting
Dr Hedgewar Hospital
Chhatrapati Sambhajinagar
Dr. Venkatesh Deshpande, 91-9881736365, venkatesh-deshpande@hedgewar.org
Dr. Venkatesh Deshpande
- Not yet recruiting
Maulana Azad Medical College
Delhi
Dr. Ravi Meher, 91-9968604237, ravimeher@gmail.com
Dr. Ravi Meher
- Recruiting
Bhagwan Mahaveer Cancer Hospital and Research Centre
Jaipur
Dr. Tej Prakash Soni, 91-9602240611, bmchrcclinicaltrial@gmail.com
Dr. Tej Prakash Soni
- Recruiting
Chittaranjan National Cancer Institute
Kolkata
Dr. K K Mukherjee, 91-9830115905, kkmukherjee4u@hotmail.com
Dr. K K Mukherjee
- Recruiting
Saroj Gupta Cancer Centre & Research Institute
Kolkata
Dr. Dhrubajyoti Mukhopadhyay, 91-9831142992, researchccwhri@gmail.com
Dr. Dhrubajyoti Mukhopadhyay
- Recruiting
Mandya institute of medical science
Mandya
Dr. Hanumanth Prasad, 91-9916856058, drmhp@yahoo.com
Dr. Hanumanth Prasad
- Recruiting
Father Muller Medical College Hospital
Mangalore
Dr. Savita Lasrado, 91-9945361819, savita_menezes@yahoo.com
Dr. Savita Lasrado
- Recruiting
Grant Government Medical College & Sir JJ group of Hospital
Mumbai, Maharashtra, 400008
Dr. Mohan Jagade, 91-9323593627, mohanjagade@gmail.com
Dr. Mohan Jagade
- Not yet recruiting
Tata Memorial Hospital
Mumbai
Dr. Devendra Chaukar, 91-9820506232, dchaukar@gmail.com
Dr. Devendra Chaukar
- Recruiting
Government Medical Colllege Nagpur
Nagpur
Dr. Kalpana Dasgupta, 91-9822229496, drkalpanadasgupta@gmail.com
Dr. Kalpana Dasgupta
- Recruiting
Shree hospital and critical care centre
Nagpur
Dr. Ashish Chikhale, 91-9850853253, shreehospitalcriticalcare@gmail.com
Dr. Ashish Chikhale
- Recruiting
Curie Manavata Cancer Centre
Nashik, Maharashtra
Dr. Suwarna Tambade, 91-9130715188, drsuwarna@manavatacancercentre.com
Dr. Suwarna Tambade
- Recruiting
Manas Hospital
Nashik, Maharashtra
Dr. Bhushan Nemade, 91-9766126162, manassuperspeciality@gmail.com
Dr. Bhushan Nemade
- Not yet recruiting
Sir Ganga Ram Hospital
New Delhi
Dr. Ajay Swaroop, 91-9811021911, swaroopent@yahoo.com
Dr. Ajay Swaroop
- Recruiting
Ashwin Medical Foundations Moraya Multispeciality Hospital
Pune
Dr. Ravindra Kulkarni, 91-9422300251, drravindrakulkarni@gmail.com
Dr. Ravindra Kulkarni
- Not yet recruiting
Deenanath Mangeshkar Hospital and Research Centre
Pune
Dr. Bharat Purandare, 91-9923456046, bharatpurandare@gmail.com
Dr. Bharat Purandare
- Recruiting
P.D.E.AS Ayurved Rugnalaya & Sterling Multispeciality Hospital
Pune
Dr. Rakesh Neve, 91-9881143140, rakesh.neve@gmail.com
Dr. Rakesh Nave
- Recruiting
Rajiv Gandhi Institute of Medical Science and RIMS Government Hospital
Srikakulam
Dr. BLN Prasad, 91-9848211931, amcmedicine@hotmail.com
Dr. BLN Prasad
- Not yet recruiting
Apple Hospital
Surat
Dr. Ghanshyam N Patel, 91-9376913131, drgnpatelonco@gmail.com
Dr. Ghanshyam N Patel
- Recruiting
Asian Institute of Medical Science
Thane
Dr. Neha Pangam, 91-9833723155, nehapangam@hotmail.com
Dr. Neha Pangam
- Recruiting
Kailash cancer hospital and research center
Vadodara
Dr. Shehnaz Kanthariya, 91-9537511001, shehnazkantharia@gmail.com
Dr. Shehnaz Kanthariya
- Recruiting
Medical College and S.S.G Hospital
Vadodara
Dr. Vimal Batra, 91-9825350509, vimalbatra@rediffmail.com
Dr. Vimal Batra
- Recruiting
S.B.K.S. Medical Institute & Research Centre
Vadodara
Dr. Ajay George, 91-8980178187, doc-ajay@yahoo.com
Dr. Ajay George
About this study
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 ".
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
Read the 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:
- Visit 1 - Screening visit (-7 Days).
- Visit 2 - Randomization (Day 1).
- Visit 3 - Follow Up (Day 8 (+2)).
- Visit 4 - Follow Up (Day 15 (+2)).
- 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.
- Conditions
- Oropharyngeal Candidiasis
- Being tested
- Unique Pharmaceutical Laboratories, India, Roxane Laboratories Inc., USA
- Keywords
- Oropharyngeal Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unique Pharmaceutical Laboratories, IndiaDrug
Clotrimazole troche/ lozenges, 10 mg 5 times a day for 14 consecutive days
Roxane Laboratories Inc., USADrug
Clotrimazole Troche/ Lozenges USP, 10 mg 5 times a day for 14 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Roxane Laboratories Inc., USA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days after the end of the therapy, (Day 21(+/- 4)
Secondary outcomes (1)
Mycological Cure
Mycological cure (negative culture and negative KOH for Candida species) at Day 15(+2) of therapy.
Measured: Day 15(+2) of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startDec 2016
- Primary completionSep 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thinq Pharma-CRO Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Unique Pharmaceuticals Ltd, India, THINQ Pharma CRO Ltd.
- Responsible party
- Sponsor
- Investigators
- Shalini Kumar, Medical, Study director, Director Medical Services, Unique Pharmacutical Laboratories, India (A Division Of J. B. Chemicals and Pharmacuticals Limited)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635438
- Sponsor's protocol ID
- TPC-CLT-002
- Acronym
- TPC
- Status last verified
- Oct 2017
- First submitted
- 16 Dec 2015
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 ".
- ClinicalTrials.gov ID
- NCT02635438
- Acronym / sponsor ID
- TPC / TPC-CLT-002
- Conditions
- Oropharyngeal Candidiasis
- Keywords
- Oropharyngeal Candidiasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Thinq Pharma-CRO Pte. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Unique Pharmaceuticals Ltd, India, THINQ Pharma CRO Ltd.
- Study start
- Dec 2016 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- Visit 1 - Screening visit (-7 Days).
- Visit 2 - Randomization (Day 1).
- Visit 3 - Follow Up (Day 8 (+2)).
- Visit 4 - Follow Up (Day 15 (+2)).
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Unique Pharmaceutical Laboratories, IndiaTest Product: Clotrimazole troche/ lozenges USP, 10 mg (Unique Pharmaceutical Laboratories, India) 10mg troche 5 times a day for 14 consecutive days |
| Arm B | Active comparator | Drug: Roxane Laboratories Inc., USAReference Product: Clotrimazole Troche/Lozenges ® 10mg (Roxane Laboratories Inc., USA) troche 5 times a day for 14 consecutive days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unique Pharmaceutical Laboratories, IndiaClotrimazole troche/ lozenges, 10 mg 5 times a day for 14 consecutive days | Drug | Arm A |
| Roxane Laboratories Inc., USAClotrimazole Troche/ Lozenges USP, 10 mg 5 times a day for 14 consecutive days | Drug | Arm B |
Primary outcome
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.
1 secondary outcome
Mycological Cure
Time frame: Day 15(+2) of therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
Related trials for Oropharyngeal Candidiasis
RecruitingObservational study
Oropharyngeal Candidiasis (OPC) and S-ECC
Candida Infection, Oral Thrush
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalini Kumar, Medical study director
Director Medical Services, Unique Pharmacutical Laboratories, India (A Division Of J. B. Chemicals and Pharmacuticals Limited)
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Unique Pharmaceutical Laboratories, India and Roxane Laboratories Inc., USA in people with Oropharyngeal Candidiasis, run by Thinq Pharma-CRO Pte. Ltd. at 26 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kalpesh B Vispute, Medical (+912225816882 ext. 882, kalpesh@thinqcro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Cure (time frame: 7 days after the end of the therapy, (Day 21(+/- 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017.