A Comparison Of Valdecoxib 20 Mg Twice Daily and 40 Mg Daily and Placebo In The Treatment Of Sore Throat

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NCT00647829

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Study Location
Pfizer Investigational Site
Storrs, Connecticut, 06269-2011, United States
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Contact
1-800-718-1021
[email protected]
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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

- Included patients had moderate to severe pain, as measured by the Sore Throat Pain Intensity Scale (STPIS) on swallowing ≥66 mm on a 100-mm visual analogue scale (VAS) and a minimum of 4 points on the 10-point Tonsillo-Pharyngitis Score (TPS) but who were not coughing or experiencing any evidence of mouth-breathing.

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


- Patients who used throat lozenges, throat spray, cough drops or menthol-containing
products within 2 hours, short-acting analgesics/antipyretics (eg, ibuprofen) or any
form of cold medication within 8 hours, antibiotics for acute disease within 24 hours
of first dose of study medication, or presumed diagnosis of infectious mononucleosis,
known allergy or hypersensitivity to NSAIDs, COX-2 specific inhibitors, sulfonamides,
or acetaminophen were excluded.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Comparison Of Valdecoxib 20 Mg Twice Daily and 40 Mg Daily and Placebo In The Treatment Of Sore Throat
Official Title  ICMJE Clinical Protocol For A Double-Blind, Randomized, Placebo-Controlled Comparison Of The Efficacy, Safety, And Tolerability Of Bextra® (Valdecoxib) 20 Mg Twice Daily, Bextra® 40 Mg Once Daily, And Placebo In The Symptomatic Treatment Of Subjects With Pharyngitis
Brief Summary The study was performed to evaluate the analgesic efficacy, safety, and tolerability of valdecoxib 20 mg twice daily (BID), valdecoxib 40 mg once daily (QD), and placebo in patients with moderately to severely painful symptomatic sore throat over a 24-hour period. In addition, the study was to validate a new scale and criteria for measuring pain in sore throat and evaluate the effects of selective serotonin reuptake inhibitors and past sore throat pain on pain score and efficacy of analgesics. The study also examined what type of medications are commonly used for sore throat and whether this information has relevance to analgesic efficacy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pharyngitis
Intervention  ICMJE
  • Drug: valdecoxib
    valdecoxib 20 mg tablet by mouth twice daily (BID) for 2 doses over a 24-hour period
  • Drug: valdecoxib
    valdecoxib 40 mg tablet by mouth once daily (QD) for 2 doses over a 24-hour period
  • Drug: placebo
    placebo tablet by mouth for 2 doses over a 24-hour period
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intervention: Drug: valdecoxib
  • Active Comparator: Arm 2
    Intervention: Drug: valdecoxib
  • Placebo Comparator: Arm 3
    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: March 27, 2008)		197
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Included patients had moderate to severe pain, as measured by the Sore Throat Pain Intensity Scale (STPIS) on swallowing ?66 mm on a 100-mm visual analogue scale (VAS) and a minimum of 4 points on the 10-point Tonsillo-Pharyngitis Score (TPS) but who were not coughing or experiencing any evidence of mouth-breathing.

Exclusion Criteria:

  • Patients who used throat lozenges, throat spray, cough drops or menthol-containing products within 2 hours, short-acting analgesics/antipyretics (eg, ibuprofen) or any form of cold medication within 8 hours, antibiotics for acute disease within 24 hours of first dose of study medication, or presumed diagnosis of infectious mononucleosis, known allergy or hypersensitivity to NSAIDs, COX-2 specific inhibitors, sulfonamides, or acetaminophen were excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older 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 NCT00647829
Other Study ID Numbers  ICMJE A3471026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2008

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