Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat.
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pharyngitis
Intervention: Celecoxib (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: A Double Blind, Randomized, Placebo Controlled Comparison Of The Efficacy, Safety, And Tolerability Of Celecoxib In The Symptomatic Treatment Of Patients With Painful Pharyngitis
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The primary objective of this trial will be to evaluate the analgesic efficacy of celecoxib compared to placebo in patients with painful pharyngitis.
Secondary outcome: Evaluate the analgesic efficacy of celecoxib initial dose compared to placebo in patients with painful pharyngitis.Compare the analgesic efficacy of celecoxib at various doses to placebo in patients with painful pharyngitis. Assess the safety and tolerability of celecoxib to placebo in patients with painful pharyngitis. Identify the analgesic efficacy of celecoxib compared to placebo in patients with painful pharyngitis by examining patient-determined criteria for "meaningful relief" and "much improvement". Identify the analgesic efficacy of celecoxib BID compared to placebo in patients with painful pharyngitis by examining patient-determined criteria for "meaningful relief" and "much improvement". Compare the analgesic efficacy of various dosing regimens of celecoxib in patients with painful pharyngitis by examining patient-determined criteria for "meaningful relief" and "much improvement".
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Pfizer Investigational Site, Storrs, Connecticut 06269-2011, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2006
Last updated: November 26, 2007
|
