Acute Sore Throat Pain Study
Information source: Pierre Fabre Medicament
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Sore Throat Pain
Intervention: Placebo (Drug); Ibuprofen 35 mg (Drug); Ibuprofen 25 mg (Drug); Ibuprofen 15 mg (Drug); Strefen (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Pierre Fabre Medicament
Summary
"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."
Clinical Details
Official title: Analgesic Profile of 3 New Ibuprofen Lozenges (V0498TA01A 15 mg, 25 mg, 35 mg) After Single Administration in Acute Sore Throat Pain
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change from baseline of Sore Throat Pain Intensity Scale
Secondary outcome: Change from baseline of Sore Throat Pain relief ScaleChange of Sore Throat Pain Intensity Scales Local tolerability examination General tolerability (reported adverse events)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Eurofins Optimed, Gières, France
Eurofins Optimed Lyon, Pierre Bénite, France
Erfurt, Germany
Cardiff, United Kingdom
Additional Information
Starting date: February 2012
Last updated: November 9, 2012
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