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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00647829
First received: March 27, 2008
Last updated: April 23, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Pharyngitis
Drug: valdecoxib
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing [ Time Frame: 2-hour period after the first dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing [ Time Frame: 4, 6, 8, 10, 12, and 24 hours after first dose ] [ Designated as safety issue: No ]
  • Peak Sore Throat Pain Intensity Difference (PPID) on swallowing [ Time Frame: 24-hour period after the first dose ] [ Designated as safety issue: No ]
  • Throat Soreness Difference (TSD) on swallowing [ Time Frame: each post dose time point ] [ Designated as safety issue: No ]
  • Sum of Throat Soreness Difference (STSD) on swallowing [ Time Frame: 2, 4, 6, 8, 10, 12, and 24 hours after first dose ] [ Designated as safety issue: No ]
  • Peak Throat Soreness Difference (PTSD) on swallowing [ Time Frame: 24-hour period after the first dose ] [ Designated as safety issue: No ]
  • Sum of Sore Throat Relief Rating (SSTRR) on swallowing [ Time Frame: 2, 4, 6, 8, 10, 12, and 24 hours after first dose ] [ Designated as safety issue: No ]
  • Peak Sore Throat Relief Rating (PSTRR) on swallowing [ Time Frame: 24-hour period after the first dose ] [ Designated as safety issue: No ]
  • Time to onset of analgesia [ Time Frame: 2-hour period after the first dose ] [ Designated as safety issue: No ]
  • Time to rescue medication [ Time Frame: 24-hour period after the first dose ] [ Designated as safety issue: No ]
  • Patient's global evaluation of study medication [ Time Frame: 24-hour period after the first dose ] [ Designated as safety issue: No ]
  • Percent of patients taking rescue medications [ Time Frame: 24-hour period after the first dose ] [ Designated as safety issue: No ]
  • Sore Throat Relief Rating (STRR) on swallowing [ Time Frame: post dose time point ] [ Designated as safety issue: No ]
  • Patient's satisfaction with treatment [ Time Frame: 24-hour period after the first dose ] [ Designated as safety issue: No ]
  • Sore Throat Pain Intensity Difference (PID, VAS) on swallowing [ Time Frame: each post dose time point ] [ Designated as safety issue: No ]
  • Time to perceptible pain relief [ Time Frame: 2-hour period after the first dose ] [ Designated as safety issue: No ]
  • Time to meaningful pain relief [ Time Frame: 2-hour period after the first dose ] [ Designated as safety issue: No ]

Enrollment: 197
Study Start Date: February 2003
Study Completion Date: December 2003
Arms Assigned Interventions
Active Comparator: Arm 1 Drug: valdecoxib
valdecoxib 20 mg tablet by mouth twice daily (BID) for 2 doses over a 24-hour period
Active Comparator: Arm 2 Drug: valdecoxib
valdecoxib 40 mg tablet by mouth once daily (QD) for 2 doses over a 24-hour period
Placebo Comparator: Arm 3 Drug: placebo
placebo tablet by mouth for 2 doses over a 24-hour period

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647829

Locations
United States, Connecticut
Pfizer Investigational Site
Storrs, Connecticut, United States, 06269-2011
United States, Florida
Pfizer Investigational Site
Boca Raton, Florida, United States, 33433
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00647829     History of Changes
Other Study ID Numbers: A3471026
Study First Received: March 27, 2008
Last Updated: April 23, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
pharyngitis, sore throat

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Valdecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014