Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00402987

Purpose

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.

Condition	Intervention	Phase
Pharyngitis	Drug: celecoxib Other: placebo	Phase III

MedlinePlus related topics: Sore Throat

Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Double Blind, Randomized, Placebo Controlled Comparison Of The Efficacy, Safety, And Tolerability Of Celecoxib In The Symptomatic Treatment Of Patients With Painful Pharyngitis

Further study details as provided by Pfizer:

Primary Outcome Measures:

The primary objective of this trial will be to evaluate the analgesic efficacy of celecoxib compared to placebo in patients with painful pharyngitis. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the analgesic efficacy of celecoxib initial dose compared to placebo in patients with painful pharyngitis. [ Time Frame: 2,6,12 and 24 hours ] [ Designated as safety issue: No ]
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". [ Time Frame: 2,6,12 and 24 hours ] [ Designated as safety issue: No ]
Compare the analgesic efficacy of celecoxib at various doses to placebo in patients with painful pharyngitis. [ Time Frame: 2,6,12 and 24 hours ] [ Designated as safety issue: No ]
Assess the safety and tolerability of celecoxib to placebo in patients with painful pharyngitis. [ Time Frame: 2,6,12 and 24 hours ] [ Designated as safety issue: No ]
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". [ Time Frame: 2,6,12 and 24 hours ] [ Designated as safety issue: No ]
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". [ Time Frame: 2,6,12 and 24 hours ] [ Designated as safety issue: No ]

Enrollment:	268
Study Start Date:	November 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
50mg celecoxib: Experimental	Drug: celecoxib 50mg celecoxib followed 6-12 hours later by 50mg celecoxib
100mg celecoxib: Experimental	Drug: celecoxib 100mg followed 6-12 hours later by 50mg celecoxib
100mg celecoxib followed by placebo: Experimental	Drug: celecoxib 100mg followed 6-12 hours later by placebo
placebo: Placebo Comparator	Other: placebo Placebo followed 6-12 hours later by placebo

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402987

Locations

United States, Connecticut
Pfizer Investigational Site
Storrs, Connecticut, United States, 06269-2011

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:	A3191334
Study First Received:	November 21, 2006
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00402987
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

sore throat, acute pain

Study placed in the following topic categories:

Celecoxib
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Pain
Stomatognathic Diseases
Pharyngitis
Pharyngeal Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
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 January 16, 2009