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Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat

Last updated on May 10, 2018

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Study Location
Pfizer Investigational Site
Storrs, Connecticut, 06269-2011 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pharyngitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00402987
Pfizer
Completed
Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat

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Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat
A Double Blind, Randomized, Placebo-Controlled Comparison of the Efficacy, Safety, and Tolerability of Celecoxib 100-150 mg, Including Initial Doses of 50 and 100 mg, and Placebo in the Symptomatic Treatment of Patients With Painful Pharyngitis
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pharyngitis
  • Drug: celecoxib
    dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
  • Drug: celecoxib followed by placebo
    dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
  • Drug: celecoxib
    dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
  • Drug: placebo
    dose 1 placebo followed 6-12 hours later by dose 2 placebo
  • Experimental: celecoxib 50 mg/50 mg
    Intervention: Drug: celecoxib
  • Experimental: celecoxib 100 mg/placebo
    Intervention: Drug: celecoxib followed by placebo
  • Experimental: celecoxib 100 mg/50 mg
    Intervention: Drug: celecoxib
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
269
November 2007
November 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00402987
A3191334
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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