Analgesic profile of 3 new Ibuprofen lozenges (V0498TA01A 15mg, 25mg,35mg) after single administration in acute sore throat pain

PIERRE FABRE MEDICAMENT0 sites185 target enrollmentJuly 20, 2012

Overview

No summary available.

Registry

who.int

Start Date

July 20, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- Male or female patients 18 years and older.
•\- patients with a sore throat associated or not with an URTI \= 24 hours and \< or \= 5 days duration, in the absence of Streptococcus group A. as confirmed by a swab test before randomisation
•\- patients with tonsillopharyngitis \= 6 on 21\-point TPA (Tonsillo Pharyngitis Assessment) scale.
•\- patients with a Sore Throat Intensity Scale assessed by VAS more than
•or equal to 60 mm.
•\- For female patients of child\-bearing potential:
•\- Negative urinary pregnancy test.
•\- Use of an effective contraceptive method (oral contraception, surgical
•method, intra\-uterine device or diaphragm) during the study and at least
•one week after the study end visit or

•Related to pathologies
•\- patients with pharyngeal paresthesia.
•\- patients with pharyngeal mycosis.
•\- patients with known peritonsillar abscess.
•\- patients with hyposialia or asialia, any swallowing disorder.
•\- patients with any painful condition that may have distracted attention from sore throat pain, (e.g. mouth ulcers).
•\- patients with any disease that could compromise breathing such as bronchospasm or severe/instable asthma.
•\- patients with evidence of mouth\-breathing or uncomfortable coughing.
•\- patients with a history of an upper gastrointestinal ulcer within the past 30 days, who are currently experiencing clinically significant upper gastrointestinal complaints, or are currently taking medication regularly (\= 3 times in the previous week).
•\- patients with Crohn's disease or ulcerative colitis.