Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat

Viatris

Status and phase: Completed; Phase 3

Conditions: Pharyngitis

Treatments: Drug: placebo; Drug: Celecoxib; Drug: celecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00402987

A3191334

Details and patient eligibility

About

We are proposing a study in which we utilize and augment the sore throat pain model to assess the analgesic effectiveness of celecoxib compared to placebo in patients with painful pharyngitis under randomized, double-blind, placebo-controlled conditions.

Enrollment: 269 patients

Sex: All

Ages: 18 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient must have a diagnosis of pharyngitis with objective findings of tonsillo-pharyngitis.
• The patient is willing to take "nothing by mouth" including inhaled treatments except trial medication during the two hours while at the site and following trial drug administration (e.g. not smoking, food, drink, candy, lozenges, chewing gum). The patient will be allowed food and drink between hours 2 and 24, but no other oral or inhaled treatments such as smoking, lozenges, chewing gum. After the two hour assessment, the patients will be allowed food and drink within one half-hour following any hourly evaluations sore throat.

Exclusion criteria

• The patient has used any analgesic/antipyretic within 1 dosing interval preceding administration of the first dose of trial medication.
• The patient anticipates using any inhaled therapy including beta-agonists (e.g., ventolin) during the 24 hour trial period and, if used, has only used inhaled therapy on an intermittent basis in the week prior to the screening visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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269 participants in 4 patient groups, including a placebo group

celecoxib 50 mg/50 mg

Experimental group

Treatment:

Drug: Celecoxib

Drug: Celecoxib

celecoxib 100 mg/placebo

Experimental group

Treatment:

Drug: Celecoxib

Drug: Celecoxib

celecoxib 100 mg/50 mg

Experimental group

Treatment:

Drug: celecoxib

Placebo

Placebo Comparator group

Treatment:

Drug: placebo