Clinical trial NCT00402987: Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pharyngitis
Keywords: sore throat
acute pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-11-23
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose
timeFrame: 2 hours Post-First Dose
Secondary outcomes:
measure: Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose
timeFrame: Within First 6 hours Post-First Dose
measure: Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose
timeFrame: 7 to 24 hours
measure: Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose
timeFrame: up to 6 hours
measure: Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose
timeFrame: 7 to 24 hours
measure: Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose
timeFrame: within the first 6 hours
measure: Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose
timeFrame: 7 to 24 hours
measure: Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose
timeFrame: at 6 hours
measure: Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose
timeFrame: 12 hours
measure: Time to Perceptible Pain Relief
timeFrame: Within 2 Hours Post-First Dose
measure: Time to Meaningful Pain Relief
timeFrame: Within 2 Hours Post-First Dose
measure: Time to Onset of Analgesia
timeFrame: Within 2 Hours Post-First Dose
measure: Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose
timeFrame: 6 Hours Post-First Dose
measure: Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose
timeFrame: 12 and 24 hours Post-First Dose
Other outcomes:
measure: Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose
timeFrame: Within first 6 hours post-first dose
measure: Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose
timeFrame: 7 to 24 hours post-first dose
measure: Sore Throat Pain Intensity Difference (SPID2) as Measured by Throat Soreness Scale (TSS) at 2 Hours Post-First Dose
timeFrame: 2 hour period Post-First Dose
measure: Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose
timeFrame: Within 6 hours Post-First Dose
measure: Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose
timeFrame: 7 to 24 hours Post-First Dose
measure: Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose
timeFrame: Within 6 hours Post-First Dose
measure: Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose
timeFrame: 7 to 24 hours Post-First Dose
measure: Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose
timeFrame: Over 2 hour Period Post-First Dose
measure: Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose
timeFrame: Within 6 hours Post-First Dose
measure: Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose
timeFrame: 7 to 24 hours Post-First Dose
measure: Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 6 Hours Post-First Dose
timeFrame: At 6 hours
measure: Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 12 Hours Post-First Dose
timeFrame: At 12 Hours
measure: Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose
timeFrame: 2 and 6 hours Post-First Dose
measure: Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose
timeFrame: 12 and 24 hours Post-First Dose
measure: Subjects With >= 50% Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose
timeFrame: 6 hours Post-First Dose
measure: Subjects With >= 50% Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose
timeFrame: 12 hours Post-First Dose
measure: Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose
timeFrame: 6 hours Post-First Dose
measure: Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose
timeFrame: 12 hours Post-First Dose
measure: Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 2 and 6 Hours Post-First Dose
timeFrame: 2 and 6 hours Post-First Dose
measure: Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 12 Hours Post-First Dose
timeFrame: 12 hours Post-First Dose
measure: Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose
timeFrame: 2 and 6 hours Post-First Dose
measure: Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose
timeFrame: 12 hours Post-First Dose
measure: Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Had Perceptible Relief Onset Time Within 1 Hour
timeFrame: Within 6 hours Post-First Dose
measure: Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Still Had Perceptible Relief at 12 and 24 Hours Post-First Dose
timeFrame: 12 and 24 hours Post-First Dose
measure: Median Onset Time of First Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose
timeFrame: 24 Hours
measure: Median Offset Time of No Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose
timeFrame: 24 Hours
measure: Treatment Failures on STRRS Questionnaire
timeFrame: 24 hours Post-First Dose
measure: Subjects Taking Rescue Medication
timeFrame: Within 24 hours Post-First Dose
measure: Treatment Satisfaction Questionnaire for Medication (TSQM vII)
timeFrame: 24 hours or immediately prior to taking rescue medication
measure: First Perceptible Relief
timeFrame: up to 24 hours
measure: No Perceptible Relief
timeFrame: up to 24 hours
Locations:
city: Storrs
country: United States
facility: University of Connecticut Student Health Services
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: