Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat

NCT ID: NCT00402987

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 269 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-04
• Study Completion Date: 2007-11-15

Brief Summary

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.

Conditions

Pharyngitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

celecoxib 50 mg/50 mg

Group Type: EXPERIMENTAL

Celecoxib

Intervention Type: DRUG

dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg

celecoxib 100 mg/placebo

Group Type: EXPERIMENTAL

Celecoxib

Intervention Type: DRUG

dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo

celecoxib 100 mg/50 mg

Group Type: EXPERIMENTAL

celecoxib

Intervention Type: DRUG

dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

dose 1 placebo followed 6-12 hours later by dose 2 placebo

Interventions

Celecoxib

dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg

Intervention Type: DRUG

Celecoxib

dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo

Intervention Type: DRUG

celecoxib

dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg

Intervention Type: DRUG

placebo

dose 1 placebo followed 6-12 hours later by dose 2 placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

University of Connecticut Student Health Services

Storrs, Connecticut, United States

Countries

United States

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191334&StudyName=Testing%20The%20Effectiveness%20Of%20Celecoxib%20In%20Patients%20With%20Painful%20Sore%20Throat

To obtain contact information for a study center near you, click here.

Other Identifiers

A3191334

Identifier Type: -

Identifier Source: org_study_id