Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat

NCT00402987 | Completed Phase 3 Results

• 1 other identifier: A3191334
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharyngitis

Keywords

sore throat; acute pain

Outcome Measures

Primary Outcomes (1)

• Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose

  Based on the Pain Intensity scores measured on a Visual Analogue Scale (PI-VAS: 0mm=no pain,100mm=worst possible pain), assessed by the subjects, the SPID2 is the area under the curve (AUC) over the 2-hour period post-first dose of the Pain Intensity Difference (PID) scores using the trapezoidal rule.

  2 hours Post-First Dose

Secondary Outcomes (13)

• Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose

  Within First 6 hours Post-First Dose

• Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose

  7 to 24 hours

• Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose

  up to 6 hours

• Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose

  7 to 24 hours

• Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose

  within the first 6 hours

Other Outcomes (31)

• Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose

  Within first 6 hours post-first dose

• Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose

  7 to 24 hours post-first dose

• Sore Throat Pain Intensity Difference (SPID2) as Measured by Throat Soreness Scale (TSS) at 2 Hours Post-First Dose

  2 hour period Post-First Dose

Study Arms (4)

celecoxib 50 mg/50 mg

EXPERIMENTAL

Drug: Celecoxib

celecoxib 100 mg/placebo

EXPERIMENTAL

Drug: Celecoxib

celecoxib 100 mg/50 mg

EXPERIMENTAL

Drug: celecoxib

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

celecoxib DRUG

dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg

celecoxib 50 mg/50 mg

placebo DRUG

dose 1 placebo followed 6-12 hours later by dose 2 placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (1)

University of Connecticut Student Health Services

Storrs, Connecticut, 06269-2011, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pharyngitis; Acute Pain

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2006
• First Posted: November 23, 2006
• Study Start: December 4, 2006
• Primary Completion: November 15, 2007
• Study Completion: November 15, 2007
• Last Updated: March 3, 2021
• Results First Posted: March 12, 2009

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)