Ibuprofen Lozenge in Acute Sore Throat Pain

Phase 3

Completed

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

• Registration Number: NCT01785862
• Lead Sponsor: Pierre Fabre Medicament

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-07
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-26
• Last Update Posted: 2013-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 427

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug	Ibuprofen 25 mg	V0498, Ibuprofen 25 mg
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Total Pain relief over 2 hours	0-2 hours post-dose	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