Ibuprofen Lozenge in Acute Sore Throat Pain

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01785862

Enrollment

427

Registered

2013-02-07

Start date

2013-02-28

Completion date

2013-06-30

Last updated

2013-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Sore Throat Pain

Keywords

sore throat pain, tonsillopharyngitis, upper respiratory tract infection

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.

Interventions

DRUGIbuprofen 25 mg

Lozenge, Oromucosal administration

DRUGPlacebo

Lozenge matching V0498 lozenge, Oromucosal administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

France, Germany, Latvia, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026