Acute Sore Throat Pain Study

Study Overview
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Brief Summary
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Sore throat is one of the most common complaints encountered in clinical practice. And in 65% of cases, the infection is thought to be viral in nature. The aim of this study is to evaluate the analgesic profile of 3 Ibuprofen lozenges after single administration in acute sore throat pain.

Official Title
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Analgesic Profile of 3 New Ibuprofen Lozenges (V0498TA01A 15 mg, 25 mg, 35 mg) After Single Administration in Acute Sore Throat Pain

Conditions
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Acute Sore Throat Pain

Intervention / Treatment
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* Drug: Placebo
* Drug: Ibuprofen 35 mg
* Drug: Ibuprofen 25 mg
* Drug: Ibuprofen 15 mg
* Drug: Strefen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female patients 18 years and older patients with a sore throat associated or not with an Upper Respiratory Tract Infection ≥ 24 hours and ≤ 5 days duration, in the absence of Streptococcus group A Exclusion Criteria: patients with hypersensitivity to Ibuprofen or other NSAIDs or the excipients. patients having used analgesics or antiseptics or any topical throat treatment or any local medication containing a local oral anaesthetic within 6 hours before study entry and who use analgesics more than ≥ 3 times per week. patients having used any anti inflammatory treatment or any long-acting or slow release analgesics within 12 hours before study entry patients having taken antibiotics within 14 days before study entry.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Single administration<br>|
| Experimental: V0498TA01A 15 mg<br> | Drug: Ibuprofen 15 mg<br>* Single administration<br>|
| Experimental: V0498TA01A 25 mg<br> | Drug: Ibuprofen 25 mg<br>* Single administration<br>|
| Experimental: V0498TA01A 35 mg<br> | Drug: Ibuprofen 35 mg<br>* Single administration<br>|
| Other: Strefen<br>Positive control | Drug: Strefen<br>* Single administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Sore Throat Pain Intensity Scale |  | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Sore Throat Pain relief Scale |  | up to 360 minutes | 
| Change of Sore Throat Pain Intensity Scales |  | up to 360 minutes | 
| Local tolerability examination | Mouth examination including extent of erythema, edema, petechial hemorrhages, ulceration (4 point scale : none, mild, moderate and severe). | Baseline (before drug intake) and 360 minutes | 
| General tolerability (reported adverse events) |  | Baseline (before drug intake) and 360 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sore throat pain, tonsillopharyngitis, upper respiratory tract infection