Health Condition 1: null- Sore Throat due to Upper Respiratory Tract Infection
Conditions
Interventions
Intervention1: Hexylresorcinol 2.4 mg lozenges and FDC of Hexylresorcinol 2.5 mg and Benzalkonium chloride 1.2 mg Lozenges: Mode of administration is One lozenge to be dissolved slowly in the mouth S
Sponsors
Remedia Therapeutics Private Limited
Lotus Clinical Research Academy
Eligibility
Inclusion criteria
Inclusion criteria: 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: 1. Patients with symptoms of primary bacterial pharyngitis or bacterial secondary infection as assessed clinically. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity difference from pre-dose baseline as rated on a 6 point VRS by the patients at 0.5, 01, 02 and 03 hours after the first lozenge.Timepoint: Pain intensity difference from pre-dose baseline as rated on a 6 point VRS by the patients at 0.5, 01, 02 and 03 hours after the first lozenge. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the difficulty in swallowing as rated on the Wong Baker Faces Pain Rating Scale by the patient at 0.5, 01, 02 and 03 hours after the first lozenge.Timepoint: Change from baseline in the difficulty in swallowing as rated on the Wong Baker Faces Pain Rating Scale by the patient at 0.5, 01, 02 and 03 hours after the first lozenge.;Final global assessment of efficacy (pain relief) by the patient.Timepoint: Final global assessment of efficacy (pain relief) by the patient. (Day 03);Time to onset of action (action defined as the first notification of change in 06 point VRS towards mild) after the first lozenge.Timepoint: Time to onset of action (action defined as the first notification of change in 06 point VRS towards mild) after the first lozenge. | — |
Countries
India
Contacts
Public ContactDr Balasubramanyam
Lotus Clinical Research Academy Pvt Ltd
Outcome results
None listed