Back to results

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

Primary Purpose

Pharyngitis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

valdecoxib

placebo

About this trial

This is an interventional treatment trial for Pharyngitis focused on measuring pharyngitis, sore throat

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Outcomes

Primary Outcome Measures

Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing

Secondary Outcome Measures

Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing

Peak Sore Throat Pain Intensity Difference (PPID) on swallowing

Throat Soreness Difference (TSD) on swallowing

Sum of Throat Soreness Difference (STSD) on swallowing

Peak Throat Soreness Difference (PTSD) on swallowing

Sum of Sore Throat Relief Rating (SSTRR) on swallowing

Peak Sore Throat Relief Rating (PSTRR) on swallowing

Time to onset of analgesia

Time to rescue medication

Patient's global evaluation of study medication

Percent of patients taking rescue medications

Sore Throat Relief Rating (STRR) on swallowing

Patient's satisfaction with treatment

Sore Throat Pain Intensity Difference (PID, VAS) on swallowing

Time to perceptible pain relief

Time to meaningful pain relief

Full Information

NCT ID

NCT00647829

First Posted

March 27, 2008

Last Updated

April 23, 2008

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00647829

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

February 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pharyngitis

Keywords

pharyngitis, sore throat

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

197 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Active Comparator

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Title

Arm 3

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

valdecoxib

Intervention Description

valdecoxib 20 mg tablet by mouth twice daily (BID) for 2 doses over a 24-hour period

Intervention Type

Drug

Intervention Name(s)

valdecoxib

Intervention Description

valdecoxib 40 mg tablet by mouth once daily (QD) for 2 doses over a 24-hour period

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo tablet by mouth for 2 doses over a 24-hour period

Primary Outcome Measure Information:

Title

Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing

Time Frame

2-hour period after the first dose

Secondary Outcome Measure Information:

Title

Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing

Time Frame

4, 6, 8, 10, 12, and 24 hours after first dose

Title

Peak Sore Throat Pain Intensity Difference (PPID) on swallowing

Time Frame

24-hour period after the first dose

Title

Throat Soreness Difference (TSD) on swallowing

Time Frame

each post dose time point

Title

Sum of Throat Soreness Difference (STSD) on swallowing

Time Frame

2, 4, 6, 8, 10, 12, and 24 hours after first dose

Title

Peak Throat Soreness Difference (PTSD) on swallowing

Time Frame

24-hour period after the first dose

Title

Sum of Sore Throat Relief Rating (SSTRR) on swallowing

Time Frame

2, 4, 6, 8, 10, 12, and 24 hours after first dose

Title

Peak Sore Throat Relief Rating (PSTRR) on swallowing

Time Frame

24-hour period after the first dose

Title

Time to onset of analgesia

Time Frame

2-hour period after the first dose

Title

Time to rescue medication

Time Frame

24-hour period after the first dose

Title

Patient's global evaluation of study medication

Time Frame

24-hour period after the first dose

Title

Percent of patients taking rescue medications

Time Frame

24-hour period after the first dose

Title

Sore Throat Relief Rating (STRR) on swallowing

Time Frame

post dose time point

Title

Patient's satisfaction with treatment

Time Frame

24-hour period after the first dose

Title

Sore Throat Pain Intensity Difference (PID, VAS) on swallowing

Time Frame

each post dose time point

Title

Time to perceptible pain relief

Time Frame

2-hour period after the first dose

Title

Time to meaningful pain relief

Time Frame

2-hour period after the first dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Storrs

State/Province

Connecticut

ZIP/Postal Code

06269-2011

Country

United States

Facility Name

Pfizer Investigational Site

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33433

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3471026&StudyName=Double-Blind%2C%20Randomized%20Protocol%20For%20Comparison%20Of%20The%20Efficacy%2C%20And%20Safety%20Of%20Valdecoxib%2020%20Mg%20Twice%20Daily%2C%20Valdecoxib%2040%20Mg%20Dai

Description

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs