Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
NCT ID:
NCT01048866
Brief Summary:
The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen lozenge throughout the course of treating sore throat due to acute pharyngitis.
Detailed Description:
Per randomization to the treatments and under double-blind conditions, patients were instructed to suck 1 sugar-based, flavoured flurbiprofen 8.75 mg lozenge or 1 sugar-based, flavoured matching vehicle control/placebo lozenge and remained at the study center for a 2-hour observation period to assess their responses to the study medication during the initial 2-hour post-dose period. Patients were allowed a dose of rescue medication (acetaminophen 650mg), as needed, post-treatment dosing during the study.
After the initial 2 hours in the research center, patients were discharged with an outpatient diary to continue (while awake) to document hourly assessments of Sore Throat Pain Intensity Scale (STPIS), Difficulty Swallowing Scale (DSS), and Swollen Throat Scale (SwoTS) through 24 hours. They used the assigned lozenges as needed every 3-6 hours, up to 5 lozenges over 24 hours. A Follow-Up Visit was conducted for the 24-hour assessments.
Patients received additional study lozenges for use as needed (up to 5 lozenges per 24 hours) over the following 6 days, rescue medication (acetaminophen 650 mg) and a Diary to document their safety and efficacy assessments immediately before and postdose after each as-needed use of a lozenge for the remaining days in the 7-day treatment period. At the end of the 7-day trial, patients returned to the research center for final assessments, review of adverse events over the week, and discharge from the study.
Study:
NCT01048866
Study Brief:
Protocol Section:
NCT01048866