CTRI Trial Data

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Clinical Trial Details (PDF Generation Date :- Sat, 25 Sep 2021 19:48:28 GMT)

CTRI Number CTRI/2012/02/002417 [Registered on: 13/02/2012] - Trial Registered Prospectively Last Modified On 28/02/2013 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group, Placebo Controlled Trial Public Title of Study A clinical trial comparing the safety and effectiveness of hexylresorcinol lozenges and combination product of hexyl resorcinol and benzalkonium chloride against placebo in relieving throat pain due to upper respiratory tract infection Scientific Title of A randomized, double blind, parallel group study comparing the Efficacy and Safety of Study Hexylresorcinol 2.4 mg lozenges and FDC of Hexylresorcinol 2.5 mg and Benzalkonium chloride 1.2 mg Lozenges with demulcent placebo lozenges in relieving pain of sore throat due to upper respiratory tract infection Secondary IDs if Any Secondary ID Identifier LA/80/2010 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Balasubramanyam Trial Coordinator (multi-center study) Designation Professor & Head Unit II Affiliation St Johns Medical College Address St Johns Medical College Hospital, Sarjapur Main Road, Koramangala, Bangalore Bangalore KARNATAKA 560034 India Phone 09341229263 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Sandhya Ravi Query) Designation Director Operations Affiliation Lotus Clinical Research Academy Pvt Ltd Address Lotus Clinical Research Academy Pvt. Ltd. 147/F || 8th Main || 3rd Block || Koramangala || Bangalore - 560 034. Karnataka. INDIA. Bangalore KARNATAKA 560034 India Phone 09845017452 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Balasubramanyam Designation Professor & Head Unit II Affiliation St Johns Medical College Address St Johns Medical College Hospital, Sarjapur Main Road, Koramangala, Bangalore Bangalore KARNATAKA

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560034 India Phone 09341229263 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Remedia Therapeutics Private Limited Primary Sponsor Primary Sponsor Details Name Remedia Therapeutics Private Limited Address Office No.1, 3rd Floor, Karmali Glass Towers, Opp. to Traffic Police Cell, S.V. Road, Panjim, Goa - 403 001 Type of Sponsor Pharmaceutical industry-Indian Details of Secondary Name Address Sponsor Lotus Clinical Research Academy 147/F,8th Main, 3rd Block, Koramangala Bangalore 560034 Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Ramesh Chandra Arogya Multispecialty first floor,Near Unity 9844145770 Sahoo Clinic hospital, Falnir Road, Mangalore- 575002 [email protected] Dakshina Kannada KARNATAKA Dr Balakrishnan D Dr.Balakrishnan Private private clinic,No-6,16th 09841910001 Clinic cross street, Indiranagar, [email protected] Chennai-600020 Chennai TAMIL NADU Dr Atul Joshi Sahyadri Hospital Ltd Department of Internal 9822430776 medicine,30C Erandwane, Karve [email protected] Road, Pune – 411004 om Pune MAHARASHTRA Dr Balasubramanyam St Johns Medical ENT department, Room 09341229263 College Hospital No.27,Sarjapur Main Road, Koramangala, [email protected] Bangalore – 560034 Bangalore KARNATAKA Dr Sandeep Nayak Uma Clinic Private 9845582363 clinic,No-1474/2, Kodigehalli circle, [email protected] Sahakarnagar post Bangalore-5600092 Bangalore KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? DrBalakrishnanD/Natio Approved 27/01/2012 Yes nalEthicscommittee/Ch ennai

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DrAtulJoshi/Sahyadriho Approved 16/04/2012 No spitalethicscommittee/P une DrBalasubramanyam/In Approved 14/02/2012 No stitutionalethicalreviewB oard/Bangalore DrRameshChandraSah Approved 25/02/2012 Yes oo/MallikattaEthicalCo mmittee/Mangalore DrSandeepNayak/IECC Approved 12/01/2012 Yes onsultantsDarussalam/ Koramangala/Bangalor e Regulatory Clearance Status Date Status from DCGI Approved/Obtained 07/12/2011 Health Condition / Health Type Condition Problems Studied Patients Sore Throat due to Upper Respiratory Tract Infection Intervention / Type Name Details Comparator Agent Intervention Hexylresorcinol 2.4 mg Mode of administration is One lozenges and FDC of lozenge to be dissolved slowly Hexylresorcinol 2.5 mg and in the mouth Subjects are Benzalkonium chloride 1.2 mg instructed to take, if required, a Lozenges maximum of 6 lozenges within a 24 hour period Hexyl resorcinol 2.4mg and FDC of Hexyl Resorcinal 2.5 mg and benzalkonium chloride 1.2 mg Duration of therapy is 3 days Comparator Agent Demulcent placebo lozenges Mode of administration is One lozenge to be dissolved slowly in the mouth Subjects are instructed to take, if required, a maximum of 6 lozenges within a 24 hour period and duration of therapy is 3 days Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 80.00 Year(s) Gender Both Details 1. Patients having sore throat associated with upper respiratory tract infection, diagnosed clinically as pharyngitis.
2. Female and male patients between the age of 18 and 80 years (inclusive of both).
3. Willing to give written informed consent.
4. The throat pain intensity is rated as at least moderate on the Verbal Rating scale (VRS) by the patient.
5. Compliance by the patient seems guaranteed, and patient seems to be able to understand and complete the subject diary card.
6. Willing to remain at the doctors practice for the initial 3 hours following the first intake of study medication or willing to comply with the documentation requirement of completing the subject diary card.
7. Willing to return for the end of study visit. Exclusion Criteria Exclusion Criteria Details 1. Patients with symptoms of primary bacterial pharyngitis or bacterial secondary infection as assessed clinically.

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2. First indication of symptoms of acute pharyngitis (e.g. sore throat) occurred more than 2 days ago. 3. Patients who in the past week required antibiotics for sore throat associated with upper respiratory tract infection. 4. Patients who in the past week required or during the study will require treatment with any of the following: steroids for oral, inhaling or topical application, expectorants or antitussives. 5. Patients who have used lozenges or any other topical throat treatment 2 hours prior to the screening, any sore throat medication containing a local anesthetic 04 hours prior to the screening, any short acting analgesic 6 hours prior to the screening and any long acting or slow-release analgesic 24 hours prior to the screening. 6. Female patients of child-bearing potential who are pregnant or currently breast feeding, or not practicing an acceptable method of birth control. 7. History of fructose intolerance or any metabolic disorder relating to glucose / sucrose ingestion. 8. Patients with known diabetes mellitus. 9. Patients with mouth breathing as a result of nasal congestion. 10. Known hypersensitivity to hexylresorcinol or benzalkonium chloride or any auxiliary substances contained in the lozenges. 11. Any existing malignancy. 12. Chronic smokers, tobacco chewers, alcoholics and those with a history of drug abuse. 13. Any clinical condition which, in the opinion of the investigator would not allow safe completion of the study and safe administration of study medication. 14. Patients who will be unable to comply fully with the protocol requirements. 15. Any investigational therapy within 30 days prior to randomization into this study. 16. Patients who are unable to comply with documentation required in the diary card for the study. Method of Generating Computer generated randomization Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment Blinding/Masking Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints Pain intensity difference from pre-dose baseline Pain intensity difference from pre-dose baseline as rated on a 6 point VRS by the patients at 0.5, as rated on a 6 point VRS by the patients at 0.5, 01, 02 and 03 hours after the first lozenge. 01, 02 and 03 hours after the first lozenge. Secondary Outcome Outcome Timepoints Time to onset of action (action defined as the Time to onset of action (action defined as the first notification of change in 06 point VRS first notification of change in 06 point VRS towards mild) after the first lozenge. towards mild) after the first lozenge. Change from baseline in the difficulty in Change from baseline in the difficulty in swallowing as rated on the Wong Baker Faces swallowing as rated on the Wong Baker Faces Pain Rating Scale by the patient at 0.5, 01, 02 Pain Rating Scale by the patient at 0.5, 01, 02 and 03 hours after the first lozenge. and 03 hours after the first lozenge. Final global assessment of efficacy (pain relief) Final global assessment of efficacy (pain relief) by the patient. by the patient. (Day 03) Target Sample Size Total Sample Size=120 Sample Size from India=120 Final Enrollment numbers achieved (Total)= Final Enrollment numbers achieved (India)= Phase of Trial Phase 3

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Date of First 17/02/2012 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=3 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details No data available yet for publication on this study Brief Summary This is a phase 3, randomized, double blind, parallel group study comparing the Efficacy and Safety of Hexylresorcinol 2.4 mg lozenges and FDC of Hexylresorcinol 2.5 mg and Benzalkonium chloride 1.2 mg Lozenges with demulcent placebo lozenges in relieving pain of sore throat due to upper respiratory tract infection.

Rationale for the study:

The clinical dilemma surrounding the treatment of sore throat suggests requirement for a non-antibiotic medication that meets patients expectations for providing rapid relief. Sore throat lozenges, hexylresorcinol is a phenolic antiseptic and also has local anesthetic effects. The antiseptic action kills the bacteria that may be associated with sore throats, while its anesthetic action helps relieve the pain. Benzalkonium chloride, an active ingredient of the fixed dose combination lozenges, is an antiseptic and disinfectant agent, which is active against various bacteria. It kills microorganisms that may be associated with various mouth and throat infections that cause a sore throat. The novel formulation combining hexylresorcinol and benzalkonium chloride is expected to provide an antiseptic effect supported by an analgesic effect for the management of sore throat associated with viral pharyngitis where there is no role for the use of antibiotics. The general use of antibiotics involves the risk of the development of resistant bacteria. The risks of prescribing antibiotics in patients with viral pharyngitis include the common side effects of antibiotics and the rare occurrence of anaphylaxis. This study is being done to demonstrate the efficacy of hexylresorcinol lozenges 2.4 mg and fixed dose combination of hexylresorcinol 2.5 mg and benzalkonium 1.2 mg lozenges in relieving pain associated with sore throat due to pharyngitis. The addition of a placebo arm is to provide a necessary statistical significance.

Study Objective:

The objective of this study is to investigate the efficacy and safety of a single dose of hexylresorcinol 2.4 mg lozenges, FDC of hexylresorcinol 2.5 mg and benzalkonium chloride 1.2 mg lozenges in comparison with demulcent placebo lozenges in relieving pain of sore throat due to upper respiratory tract infection.

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