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Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00402987
First Posted: November 23, 2006
Last Update Posted: June 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
November 21, 2006
November 23, 2006
November 14, 2008
March 12, 2009
June 11, 2009
November 2006
November 2007   (Final data collection date for primary outcome measure)
Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose [ Time Frame: 2 hours Post-First Dose ]
The primary objective of this trial will be to evaluate the analgesic efficacy of celecoxib compared to placebo in patients with painful pharyngitis.
Complete list of historical versions of study NCT00402987 on ClinicalTrials.gov Archive Site
  • Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose [ Time Frame: Within First 6 hours Post-First Dose ]
  • Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose [ Time Frame: 7 to 24 hours ]
  • Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose [ Time Frame: up to 6 hours ]
  • Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose [ Time Frame: 7 to 24 hours ]
  • Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose [ Time Frame: within the first 6 hours ]
  • Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose [ Time Frame: 7 to 24 hours ]
  • Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose [ Time Frame: at 6 hours ]
  • Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose [ Time Frame: 12 hours ]
  • Time to Perceptible Pain Relief [ Time Frame: Within 2 Hours Post-First Dose ]
  • Time to Meaningful Pain Relief [ Time Frame: Within 2 Hours Post-First Dose ]
  • Time to Onset of Analgesia [ Time Frame: Within 2 Hours Post-First Dose ]
  • Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose [ Time Frame: 6 Hours Post-First Dose ]
  • Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose [ Time Frame: 12 and 24 hours Post-First Dose ]
  • 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".
Not Provided
Not Provided
 
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