Acute Sore Throat Pain Study

Analgesic Profile of 3 New Ibuprofen Lozenges (V0498TA01A 15 mg, 25 mg, 35 mg) After Single Administration in Acute Sore Throat Pain

"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."

Study Overview

• Status: Completed
• Conditions: Acute Sore Throat Pain
• Intervention / Treatment: Drug: Placebo; Drug: Ibuprofen 15 mg; Drug: Ibuprofen 25 mg; Drug: Ibuprofen 35 mg; Drug: Strefen

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Gières, France
    • Eurofins Optimed
  • Pierre Bénite, France
    • EUROFINS OPTIMED Lyon
• Germany
  • Erfurt, Germany
• United Kingdom
  • Cardiff, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Single administration
Experimental: V0498TA01A 15 mg	Drug: Ibuprofen 15 mg; Single administration
Experimental: V0498TA01A 25 mg	Drug: Ibuprofen 25 mg; Single administration
Experimental: V0498TA01A 35 mg	Drug: Ibuprofen 35 mg; Single administration
Other: Strefen; Positive control	Drug: Strefen; Single administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline of Sore Throat Pain Intensity Scale	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of Sore Throat Pain relief Scale		up to 360 minutes
Change of Sore Throat Pain Intensity Scales		up to 360 minutes
Local tolerability examination	Mouth examination including extent of erythema, edema, petechial hemorrhages, ulceration (4 point scale : none, mild, moderate and severe).	Baseline (before drug intake) and 360 minutes
General tolerability (reported adverse events)		Baseline (before drug intake) and 360 minutes

Collaborators and Investigators

• Sponsor: Pierre Fabre Medicament

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: February 10, 2012
• First Submitted That Met QC Criteria: February 16, 2012
• First Posted (Estimate): February 17, 2012

Study Record Updates

• Last Update Posted (Estimate): November 12, 2012
• Last Update Submitted That Met QC Criteria: November 9, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: sore throat pain; tonsillopharyngitis; upper respiratory tract infection
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: V00498 TA 2 01; 2011-005848-10 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No