DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 Scale

Change 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017