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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004423-20 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy and safety of repeated doses of a low dosage of oromucosal Ibuprofen form (lozenge) versus placebo in patients suffering from acute sore throat pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug | Experimental | V0498, Ibuprofen 25 mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen 25 mg | Drug | Lozenge, Oromucosal administration |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Total Pain relief over 2 hours | Total Pain Relief (TOTPAR) assessed on a 7-point rating scale called the Sore Throat Relief Scale (STRS) over 120min after the start of sucking of 1st study drug administered | 0-2 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gières | France | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28869722 | Derived | Bouroubi A, Donazzolo Y, Donath F, Eccles R, Russo M, Harambillet N, Gautier S, Montagne A. Pain relief of sore throat with a new anti-inflammatory throat lozenge, ibuprofen 25 mg: A randomised, double-blind, placebo-controlled, international phase III study. Int J Clin Pract. 2017 Sep;71(9). doi: 10.1111/ijcp.12961. Epub 2017 Sep 4. |
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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 |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
Lozenge matching V0498 lozenge, Oromucosal administration |
|
| Erfurt |
| Germany |
| Balvi | Latvia |
| Daugavpils | Latvia |
| Jelgava | Latvia |
| Jēkabpils | Latvia |
| Kuldīga | Latvia |
| Liepāja | Latvia |
| Ogre | Latvia |
| Ogres Municipality | Latvia |
| Riga | Latvia |
| Saldus | Latvia |
| Cardiff | United Kingdom |
| Glasgow | United Kingdom |