Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
186 participants
INTERVENTIONAL
2012-02-29
2012-11-30
Brief Summary
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The aim of this study is to evaluate the analgesic profile of 3 Ibuprofen lozenges after single administration in acute sore throat pain."
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo
Single administration
V0498TA01A 15 mg
Ibuprofen 15 mg
Single administration
V0498TA01A 25 mg
Ibuprofen 25 mg
Single administration
V0498TA01A 35 mg
Ibuprofen 35 mg
Single administration
Strefen
Positive control
Strefen
Single administration
Interventions
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Placebo
Single administration
Ibuprofen 35 mg
Single administration
Ibuprofen 25 mg
Single administration
Ibuprofen 15 mg
Single administration
Strefen
Single administration
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Pierre Fabre Medicament
INDUSTRY
Responsible Party
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Locations
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Eurofins Optimed
Gières, , France
Eurofins Optimed Lyon
Pierre-Bénite, , France
Erfurt, , Germany
Cardiff, , United Kingdom
Countries
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Other Identifiers
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2011-005848-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V00498 TA 2 01
Identifier Type: -
Identifier Source: org_study_id