Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00402987
First received: November 21, 2006
Last updated: June 8, 2009
Last verified: June 2009

November 21, 2006
June 8, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose [ Time Frame: 7 to 24 hours ] [ Designated as safety issue: No ]
  • Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose [ Time Frame: up to 6 hours ] [ Designated as safety issue: No ]
  • Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose [ Time Frame: 7 to 24 hours ] [ Designated as safety issue: No ]
  • Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose [ Time Frame: within the first 6 hours ] [ Designated as safety issue: No ]
  • Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose [ Time Frame: 7 to 24 hours ] [ Designated as safety issue: No ]
  • Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose [ Time Frame: at 6 hours ] [ Designated as safety issue: No ]
  • Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Time to Perceptible Pain Relief [ Time Frame: Within 2 Hours Post-First Dose ] [ Designated as safety issue: No ]
  • Time to Meaningful Pain Relief [ Time Frame: Within 2 Hours Post-First Dose ] [ Designated as safety issue: No ]
  • Time to Onset of Analgesia [ Time Frame: Within 2 Hours Post-First Dose ] [ Designated as safety issue: No ]
  • Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose [ Time Frame: 6 Hours Post-First Dose ] [ Designated as safety issue: No ]
  • Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose [ Time Frame: 12 and 24 hours Post-First Dose ] [ Designated as safety issue: No ]
  • 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00402987
A3191334
No
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