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

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 Drug: celecoxib followed by placebo Drug: placebo	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Sore Throat

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose [ Time Frame: 2 hours Post-First Dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose [ Time Frame: Within First 6 hours Post-First Dose ] [ Designated as safety issue: No ]
Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose [ Time Frame: 7 to 24 hours ] [ Designated as safety issue: No ]
Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose [ Time Frame: up to 6 hours ] [ Designated as safety issue: No ]
Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose [ Time Frame: 7 to 24 hours ] [ Designated as safety issue: No ]
Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose [ Time Frame: within the first 6 hours ] [ Designated as safety issue: No ]
Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose [ Time Frame: 7 to 24 hours ] [ Designated as safety issue: No ]
Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose [ Time Frame: at 6 hours ] [ Designated as safety issue: No ]
Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
Time to Perceptible Pain Relief [ Time Frame: Within 2 Hours Post-First Dose ] [ Designated as safety issue: No ]
Time to Meaningful Pain Relief [ Time Frame: Within 2 Hours Post-First Dose ] [ Designated as safety issue: No ]
Time to Onset of Analgesia [ Time Frame: Within 2 Hours Post-First Dose ] [ Designated as safety issue: No ]
Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose [ Time Frame: 6 Hours Post-First Dose ] [ Designated as safety issue: No ]
Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose [ Time Frame: 12 and 24 hours Post-First Dose ] [ Designated as safety issue: No ]

Enrollment:	269
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
Experimental: celecoxib 50 mg/50 mg	Drug: celecoxib dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
Experimental: celecoxib 100 mg/placebo	Drug: celecoxib followed by placebo dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
Experimental: celecoxib 100 mg/50 mg	Drug: celecoxib dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
Placebo Comparator: placebo	Drug: placebo dose 1 placebo followed 6-12 hours later by dose 2 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

Additional Information:

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

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00402987 History of Changes
Other Study ID Numbers:	A3191334
Study First Received:	November 21, 2006
Results First Received:	November 14, 2008
Last Updated:	June 8, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

sore throat
acute pain

Additional relevant MeSH terms:

Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Celecoxib
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
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013