Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat

NCT00402987

Last updated date
Study Location
University of Connecticut Student Health Services
Storrs, Connecticut, 06269-2011, United States
Contact
1-800-718-1021

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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pharyngitis
Intervention  ICMJE
  • Drug: Celecoxib
    dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
  • Drug: Celecoxib
    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
Study Arms  ICMJE
  • Experimental: celecoxib 50 mg/50 mg
    Intervention: Drug: Celecoxib
  • Experimental: celecoxib 100 mg/placebo
    Intervention: Drug: Celecoxib
  • Experimental: celecoxib 100 mg/50 mg
    Intervention: Drug: celecoxib
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2009)
269
Original Enrollment  ICMJE
 (submitted: November 22, 2006)
268
Actual Study Completion Date  ICMJE November 15, 2007
Actual Primary Completion Date November 15, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 18 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00402987
Other Study ID Numbers  ICMJE A3191334
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP