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Acute Sore Throat Pain Study

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01535079
Enrollment
186
Registered
2012-02-17
Start date
2012-02-29
Completion date
2012-11-30
Last updated
2012-11-12

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

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.

Interventions

DRUGPlacebo

Single administration

DRUGIbuprofen 35 mg

Single administration

DRUGIbuprofen 25 mg

Single administration

DRUGIbuprofen 15 mg

Single administration

DRUGStrefen

Single administration

Sponsors

Pierre Fabre Medicament
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change from baseline of Sore Throat Pain Intensity Scale60 minutes

Secondary

MeasureTime frameDescription
Change from baseline of Sore Throat Pain relief Scaleup to 360 minutes—
Change of Sore Throat Pain Intensity Scalesup to 360 minutes—
Local tolerability examinationBaseline (before drug intake) and 360 minutesMouth examination including extent of erythema, edema, petechial hemorrhages, ulceration (4 point scale : none, mild, moderate and severe).
General tolerability (reported adverse events)Baseline (before drug intake) and 360 minutes—

Countries

France, Germany, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026