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

NCT00647829 | Completed Phase 3

• 1 other identifier: A3471026
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 2

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.

Conditions

Pharyngitis

Keywords

pharyngitis, sore throat

Outcome Measures

Primary Outcomes (1)

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

  2-hour period after the first dose

Secondary Outcomes (16)

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

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

• Peak Sore Throat Pain Intensity Difference (PPID) on swallowing

  24-hour period after the first dose

• Throat Soreness Difference (TSD) on swallowing

  each post dose time point

• Sum of Throat Soreness Difference (STSD) on swallowing

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

• Peak Throat Soreness Difference (PTSD) on swallowing

  24-hour period after the first dose

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

Drug: valdecoxib

Arm 2

ACTIVE COMPARATOR

Drug: valdecoxib

Arm 3

PLACEBO COMPARATOR

Drug: placebo

Interventions

valdecoxib DRUG

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

Arm 1

placebo DRUG

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

Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer Investigational Site

Storrs, Connecticut, 06269-2011, United States

Location

Pfizer Investigational Site

Boca Raton, Florida, 33433, United States

Location

Related Links

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

MeSH Terms

Conditions

Pharyngitis

Interventions

valdecoxib

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: April 1, 2008
• Study Start: February 1, 2003
• Study Completion: December 1, 2003
• Last Updated: April 24, 2008

Record last verified: 2008-04

Locations

US (2)