Clinical Trial: Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double Blind, Randomized, Placebo-Controlled Comparison of the Efficacy, Safety, and Tolerability of Celecoxib 100-150 mg, Including Initial Doses of 50 and 100 mg, and Placebo in the Symptomatic Tr
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.
Detailed Summary:
Sponsor: Pfizer
Current Primary Outcome: Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose [ Time Frame: 2 hours Post-First Dose ]
Original Primary Outcome: The primary objective of this trial will be to evaluate the analgesic efficacy of celecoxib compared to placebo in patients with painful pharyngitis.
Current Secondary Outcome:
- Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose [ Time Frame: Within First 6 hours Post-First Dose ]
- Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose [ Time Frame: 7 to 24 hours ]
- Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose [ Time Frame: up to 6 hours ]
- Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose [ Time Frame: 7 to 24 hours ]
- Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose [ Time Frame: within the first 6 hours ]
- Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose [ Time Frame: 7 to 24 hours ]
- Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose [ Time Frame: at 6 hours ]
- Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose [ Time Frame: 12 hours ]
- Time to Perceptible Pain Relief [ Time Frame: Within 2 Hours Post-First Dose ]
- Time to Meaningful Pain Relief [ Time Frame: Within 2 Hours Post-First Dose ]
- Time to Onset of Analgesia [ Time Frame: Within 2 Hours Post-First Dose ]
- Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose [ Time Frame: 6 Hours Post-First Dose ]
- Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose [ Time Frame: 12 and 24 hours Post-First Dose ]
Original Secondary Outcome:
- Evaluate the analgesic efficacy of celecoxib initial dose compared to placebo in patients with painful pharyngitis.
- Compare the analgesic efficacy of celecoxib at various doses to placebo in patients with painful pharyngitis.
- Assess the safety and tolerability of celecoxib to placebo in patients with painful pharyngitis.
- Identify the analgesic efficacy of celecoxib compared to placebo in patients with painful pharyngitis by examining patient-determined criteria for "meaningful relief" and "much improvement".
- Identify the analgesic efficacy of celecoxib BID compared to placebo in patients with painful pharyngitis by examining patient-determined criteria for "meaningful relief" and "much improvement.
- Compare the analgesic efficacy of various dosing regimens of celecoxib in patients with painful pharyngitis by examining patient-determined criteria for "meaningful relief" and "much improvement".
Information By: Pfizer
Dates:
Date Received: November 21, 2006
Date Started: November 2006
Date Completion:
Last Updated: June 8, 2009
Last Verified: June 2009