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

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 III

MedlinePlus related topics:

Sore Throat

ChemIDplus related topics:

Valdecoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

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

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
Arm 1: Active Comparator	Drug: valdecoxib valdecoxib 20 mg tablet by mouth twice daily (BID) for 2 doses over a 24-hour period
Arm 2: Active Comparator	Drug: valdecoxib valdecoxib 40 mg tablet by mouth once daily (QD) for 2 doses over a 24-hour period
Arm 3: Placebo Comparator	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

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

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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

Keywords provided by Pfizer:

pharyngitis, sore throat

Study placed in the following topic categories:

Otorhinolaryngologic Diseases

Respiratory Tract Diseases

Respiratory Tract Infections

Stomatognathic Diseases

Pharyngitis

Valdecoxib

Pharyngeal Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 14, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00647829