Acute Sore Throat Pain Study

Phase 2

Completed

• Conditions: Acute Sore Throat Pain
• Interventions: Drug: Placebo; Drug: Ibuprofen 15 mg; Drug: Ibuprofen 25 mg; Drug: Ibuprofen 35 mg; Drug: Strefen

• Registration Number: NCT01535079
• Lead Sponsor: Pierre Fabre Medicament

Brief 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."

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-10
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-17
• Status Verified: 2012-10
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-09
• Last Update Posted: 2012-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
V0498TA01A 15 mg	Ibuprofen 15 mg	-
V0498TA01A 25 mg	Ibuprofen 25 mg	-
V0498TA01A 35 mg	Ibuprofen 35 mg	-
Strefen	Strefen	Positive control

Primary Outcome Measures

Name	Time	Method
Change from baseline of Sore Throat Pain Intensity Scale	60 minutes

Secondary Outcome Measures

Name	Time	Method
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	Baseline (before drug intake) and 360 minutes	Mouth examination including extent of erythema, edema, petechial hemorrhages, ulceration (4 point scale : none, mild, moderate and severe).
General tolerability (reported adverse events)	Baseline (before drug intake) and 360 minutes

Trial Locations

Locations (2)

Eurofins Optimed; 🇫🇷 Gières, France

Eurofins Optimed Lyon; 🇫🇷 Pierre Bénite, France