Acute Sore Throat Pain Study

Pierre Fabre

Status and phase: Completed; Phase 2

Conditions: Acute Sore Throat Pain

Treatments: Drug: Ibuprofen 15 mg; Drug: Strefen; Drug: Placebo; Drug: Ibuprofen 25 mg; Drug: Ibuprofen 35 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01535079

V00498 TA 2 01

2011-005848-10 (EudraCT Number)

Details and patient eligibility

About

"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."

Enrollment: 186 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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186 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

V0498TA01A 15 mg

Experimental group

Treatment:

Drug: Ibuprofen 15 mg

V0498TA01A 25 mg

Experimental group

Treatment:

Drug: Ibuprofen 25 mg

V0498TA01A 35 mg

Experimental group

Treatment:

Drug: Ibuprofen 35 mg

Strefen

Other group

Description:

Positive control

Treatment:

Drug: Strefen