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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00647829
• Collaborator: (none)
• Enrollment: 197
• Locations: 2
• Arms: 3
• Duration (Months): 10
• Patients Per Site: 98.5
• Patients Per Site Per Month: 9.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pharyngitis	Drug: valdecoxib; Drug: valdecoxib; Drug: placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 197 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Feb 1, 2003
• Actual Study Completion Date: Dec 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1	Drug: valdecoxib; valdecoxib 20 mg tablet by mouth twice daily (BID) for 2 doses over a 24-hour period
Active Comparator: Arm 2	Drug: valdecoxib; valdecoxib 40 mg tablet by mouth once daily (QD) for 2 doses over a 24-hour period
Placebo Comparator: Arm 3	Drug: placebo; placebo tablet by mouth for 2 doses over a 24-hour period

Outcome Measures

Primary Outcome Measures

1. Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing [2-hour period after the first dose]

Secondary Outcome Measures

1. Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing [4, 6, 8, 10, 12, and 24 hours after first dose]

2. Peak Sore Throat Pain Intensity Difference (PPID) on swallowing [24-hour period after the first dose]

3. Throat Soreness Difference (TSD) on swallowing [each post dose time point]

4. Sum of Throat Soreness Difference (STSD) on swallowing [2, 4, 6, 8, 10, 12, and 24 hours after first dose]

5. Peak Throat Soreness Difference (PTSD) on swallowing [24-hour period after the first dose]

6. Sum of Sore Throat Relief Rating (SSTRR) on swallowing [2, 4, 6, 8, 10, 12, and 24 hours after first dose]

7. Peak Sore Throat Relief Rating (PSTRR) on swallowing [24-hour period after the first dose]

8. Time to onset of analgesia [2-hour period after the first dose]

9. Time to rescue medication [24-hour period after the first dose]

10. Patient's global evaluation of study medication [24-hour period after the first dose]

11. Percent of patients taking rescue medications [24-hour period after the first dose]

12. Sore Throat Relief Rating (STRR) on swallowing [post dose time point]

13. Patient's satisfaction with treatment [24-hour period after the first dose]

14. Sore Throat Pain Intensity Difference (PID, VAS) on swallowing [each post dose time point]

15. Time to perceptible pain relief [2-hour period after the first dose]

16. Time to meaningful pain relief [2-hour period after the first dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Storrs	Connecticut	United States	06269-2011
2	Pfizer Investigational Site	Boca Raton	Florida	United States	33433

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00647829
• Other Study ID Numbers: A3471026
• First Posted: Apr 1, 2008
• Last Update Posted: Apr 24, 2008
• Last Verified: Apr 1, 2008

• Keywords provided by , ,: pharyngitis, sore throat
• Additional relevant MeSH terms: Pharyngitis; Valdecoxib

Study Results

No Results Posted as of Apr 24, 2008