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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005848-10 | EudraCT Number |
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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."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| V0498TA01A 15 mg | Experimental |
| |
| V0498TA01A 25 mg | Experimental |
| |
| V0498TA01A 35 mg | Experimental |
| |
| Strefen | Other | Positive control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Single administration |
| |
| Ibuprofen 35 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of Sore Throat Pain Intensity Scale | 60 minutes |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Optimed | Gières | France | ||||
| Eurofins Optimed Lyon |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D005480 | Flurbiprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
Single administration |
|
| Ibuprofen 25 mg | Drug | Single administration |
|
| Ibuprofen 15 mg | Drug | Single administration |
|
| Strefen | Drug | Single administration |
|
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 |
| Pierre-Bénite |
| France |
| Erfurt | Germany |
| Cardiff | United Kingdom |
| D011422 |
| Propionates |
| D000144 | Acids, Acyclic |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |