Ibuprofen Lozenge in Acute Sore Throat Pain

Acute Sore Throat Pain Clinical Trial

Official title:

Study of Efficacy and Safety of V0498 Versus Placebo in Acute Sore Throat Pain.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785862
• Other study ID #: V00498 TA 3 01
• Secondary ID: 2012-004423-20
• Status: Completed
• Phase: Phase 3
• First received: February 5, 2013
• Last updated: June 26, 2013
• Start date: February 2013
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of PersonnesGermany: Federal Institute for Drugs and Medical DevicesGermany: Ethics CommissionLatvia: State Agency of MedicinesLatvia: Institutional Review BoardUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of repeated doses of a low dosage of oromucosal Ibuprofen form (lozenge) versus placebo in patients suffering from acute sore throat pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 427
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• male or female aged at least 18 years old

• patient with an acute sore throat

Exclusion Criteria:

• Severe respiratory tract infection (pneumonia, bronchitis or laryngitis)

• Oro-pharyngeal paresthesia or mycosis

• Severely traumatised and/or very severe oromucosal inflammation

• Tonsillopharyngectomy

• Peritonsillar abscess

• Hypersensitivity to ibuprofen or other NonSteroidal Anti-Inflammatory Drugs (NSAIDs) (including bronchospasm) or to excipients

• Long term use (= 3 times per week within the last month or regular intake within the last 3 months before randomisation) of antiinflammatory drugs- Any long-acting or slow release analgesic intake including NonSteroidal Anti-Inflammatory Drugs (NSAIDs)within 24 hours before randomisation (e.g. piroxicam or naproxen)

• Any anti-inflammatory drugs intake by systemic route within 12 hours before randomisation

• Any paracetamol intake within 6 hours before randomisation

• Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomisation

• Any topical throat medication intake containing or not a local oral anaesthetic such as lozenge, spray, mouth rinse within 4 hours before randomisation

• Heavy smokers (>20 cigarettes/day)

Study Design

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

Related Conditions & MeSH terms

• Acute Sore Throat Pain
• Pharyngitis

Intervention

Drug:
• Ibuprofen 25 mg
Lozenge, Oromucosal administration
• Placebo
Lozenge matching V0498 lozenge, Oromucosal administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Countries where clinical trial is conducted

France,  Germany,  Latvia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Pain relief over 2 hours	Total Pain Relief (TOTPAR) assessed on a 7-point rating scale called the Sore Throat Relief Scale (STRS) over 120min after the start of sucking of 1st study drug administered	0-2 hours post-dose	No