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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator |
| |
| Arm 2 | Active Comparator |
| |
| Arm 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valdecoxib | Drug | valdecoxib 20 mg tablet by mouth twice daily (BID) for 2 doses over a 24-hour period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing | 2-hour period after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Storrs | Connecticut | 06269-2011 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C406224 | valdecoxib |
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| valdecoxib | Drug | valdecoxib 40 mg tablet by mouth once daily (QD) for 2 doses over a 24-hour period |
|
| placebo | Drug | placebo tablet by mouth for 2 doses over a 24-hour period |
|
| 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 |
| Sum of Sore Throat Relief Rating (SSTRR) on swallowing | 2, 4, 6, 8, 10, 12, and 24 hours after first dose |
| Peak Sore Throat Relief Rating (PSTRR) on swallowing | 24-hour period after the first dose |
| Time to onset of analgesia | 2-hour period after the first dose |
| Time to rescue medication | 24-hour period after the first dose |
| Patient's global evaluation of study medication | 24-hour period after the first dose |
| Percent of patients taking rescue medications | 24-hour period after the first dose |
| Sore Throat Relief Rating (STRR) on swallowing | post dose time point |
| Patient's satisfaction with treatment | 24-hour period after the first dose |
| Sore Throat Pain Intensity Difference (PID, VAS) on swallowing | each post dose time point |
| Time to perceptible pain relief | 2-hour period after the first dose |
| Time to meaningful pain relief | 2-hour period after the first dose |
| Boca Raton |
| Florida |
| 33433 |
| United States |
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |