Acute Sore Throat Pain Study

Acute Sore Throat Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535079
• Other study ID #: V00498 TA 2 01
• Secondary ID: 2011-005848-10
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2012
• Last updated: November 9, 2012
• Start date: February 2012
• Est. completion date: November 2012

Study information

• Verified date: October 2012
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGermany: Ethics CommissionUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Sore Throat Pain
• Pharyngitis

Intervention

Drug:
• Placebo
Single administration
• Ibuprofen 35 mg
Single administration
• Ibuprofen 25 mg
Single administration
• Ibuprofen 15 mg
Single administration
• Strefen
Single administration

Locations

Country	Name	City	State
France	Eurofins Optimed	Gières
France	Eurofins Optimed Lyon	Pierre Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Countries where clinical trial is conducted

France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of Sore Throat Pain Intensity Scale		60 minutes	No
Secondary	Change from baseline of Sore Throat Pain relief Scale		up to 360 minutes	No
Secondary	Change of Sore Throat Pain Intensity Scales		up to 360 minutes	No
Secondary	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	Yes
Secondary	General tolerability (reported adverse events)		Baseline (before drug intake) and 360 minutes	Yes