STUDY OF EFFICACY AND SAFETY OF V0498 VERSUS PLACEBO IN ACUTE SORE THROAT PAIN

STUDY OF EFFICACY AND SAFETY OF V0498 VERSUS PLACEBO IN ACUTE SORE THROAT PAIN - IBUPROFEN LOZENGE IN ACUTE SORE THROAT PAIN

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004423-20-DE

Enrollment

382

Registered

2012-11-26

Start date

2013-01-10

Completion date

Unknown

Last updated

2014-01-27

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

Conditions

Acute sore throat MedDRA version: 14.1 Level: PT Classification code 10049140 Term: Pharyngotonsillitis System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: / Product Code: V0498 Pharmaceutical Form: Lozenge INN or Proposed INN: IBUPROFEN SODIUM DIHYDRATE CAS Number: 31121-93-4 Current Sponsor code: / Other descriptive name: / Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - male or female aged at least 18 years old - patient with an acute sore throat Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 260 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 122

Exclusion criteria

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 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 anti-inflammatory drugs - Any long-acting or slow release analgesic intake including 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
Timepoint(s) of evaluation of this end point: Up to 120 min;Secondary Objective: To compare the analgesic effect of V0498 ibuprofen lozenges versus placebo: • on the Sore Throat Relief Scale (STRS) • onset of meaningful pain relief • on the Sore Throat Pain Intensity Difference (PID) on swallowing • on the Sum of Pain Intensity Differences on swallowing (SPID) To assess the local and global tolerability of repeated administrations of V0498 lozenges versus placebo.;Main Objective: To compare the analgesic effect of V0498 lozenges versus placebo on the Total Pain Relief (TOTPAR). ;Primary end point(s): Total Pain Relief (TOTPAR)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Up to 120 min;Secondary Objective: To compare the analgesic effect of V0498 ibuprofen lozenges versus placebo: • on the Sore Throat Relief Scale (STRS) • onset of meaningful pain relief • on the Sore Throat Pain Intensity Difference (PID) on swallowing • on the Sum of Pain Intensity Differences on swallowing (SPID) To assess the local and global tolerability of repeated administrations of V0498 lozenges versus placebo.;Main Objective: To compare the analgesic effect of V0498 lozenges versus placebo on the Total Pain Relief (TOTPAR). ;Primary end point(s): Total Pain Relief (TOTPAR)

—

Secondary

Measure	Time frame
Secondary end point(s): Sore Throat Relief Scale (STRS) Onset of meaningful pain relief Sore Throat Pain Intensity Difference (PID) on swallowing Sum of Pain Intensity Differences (SPID) on swallowing ;Timepoint(s) of evaluation of this end point: Up to 120min and up to Day 4	—

Countries

France, Germany, Latvia, United Kingdom

Contacts

Public ContactAthmane Bouroubi

PIERRE FABRE MEDICAMENT

athmane.bouroubi@pierre-fabre.com335 34 50 63 45

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026