Clinical trial NCT01048866: A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis
Official title: A Repeat-Dose, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Study to Determine the Safety and Efficacy of Flurbiprofen 8.75 mg Lozenge Compared to Its Vehicle Control Lozenge in Patients With Painful Pharyngitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pharyngitis
Keywords: pharyngitis
swollen throat
difficulty swallowing
Lead sponsor: Reckitt Benckiser LLC
Sponsor class: INDUSTRY
First posted: 2010-01-14
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. The patient has a complaint of sore throat.
2. If the patient is a female of childbearing potential, she has been using effective contraception since the last date of menses and is not breast-feeding or lactating.
3. If the patient is a female of childbearing potential, the patient must have a negative urine pregnancy.
4. The patient has provided written informed consent prior to any study-related procedures.

Exclusion Criteria:

1. The patient has a history of an upper gastrointestinal ulcer within the past 60 days, is currently experiencing clinically significant upper gastrointestinal complaints, or is currently taking medication regularly (≥ three times in the previous week).
2. The patient has a history of any hepatic disease or renal dysfunction.
3. The patient has a history of chronic analgesic use (≥ three times per week over the prior four weeks). (Patients on low-dose aspirin therapy may be allowed in the study per investigator's clinical decision.)

Primary outcomes:
measure: Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24)
timeFrame: baseline (pre-dose), post-dose - hourly up to 24 hours
Secondary outcomes:
measure: Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline
timeFrame: Baseline (pre-dose), Hours 1 and 2 post-dose
measure: Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline
timeFrame: Baseline (pre-dose), hourly readings to 24 hours post-dose
measure: Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline
timeFrame: Baseline (pre-dose), hourly readings to 2 hours post-dose
measure: Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline
timeFrame: Baseline (pre-dose), hourly readings to 24 hours post-dose
measure: Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2)
timeFrame: baseline (pre-dose), post-dose: 1 hour, 2 hours
measure: Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale Over 24 Hours Post-baseline (STPIS SPID24) For Participants With Baseline Practitioner's Assessment of Pharyngeal Inflammation (PAIN) of Moderate or Severe
timeFrame: baseline (pre-dose), 24 hours post dose (measured each hour post dose)
measure: Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose
timeFrame: 2 hours
measure: Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose
timeFrame: 24 hours
measure: Participant Satisfaction Score 24 Hours After Initial Dose
timeFrame: 24 hours
measure: Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7)
timeFrame: Day 7 (end of study)
measure: Post 24 Hour, Multiple Dose Results: Weighted Sum of Pain Intensity Differences (SPID) Over 2 Hours for the Sore Throat Pain Intensity Scale (STPIS SPID2)
timeFrame: Days 2-7
measure: Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Difficulty Swallowing Scale (DSS2)
timeFrame: Days 2-7
measure: Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Swollen Throat Scale (SwoTS2)
timeFrame: Days 2-7
measure: Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing
timeFrame: Days 2-7
measure: Percentage of Participants Who Took Rescue Pain Medication
timeFrame: Days 1-7
measure: Time to First Rescue Pain Medication
timeFrame: Days 1-7
measure: Change From Baseline in Body Temperature at 2 Hours Post Initial Dose
timeFrame: baseline (pre-dose), 2 hours post-dose
measure: Change From Baseline in Body Temperature at End of Study
timeFrame: baseline (pre-dose), up to Day 7
Other outcomes:
Locations:
city: New York
country: United States
facility: Bluestone Center for Clinical Research
state: New York
Study officials:
affiliation: Reckitt Benckiser Inc.
name: Timothy J Shea, BS
role: STUDY_DIRECTOR
References:
citation: Schachtel B, Aspley S, Berry P, Muir N, Shephard A, Shea T, Smith G, Schachtel E. Efficacy of a novel (lozenge) delivery of flurbiprofen over 24 hours. Journal of Pain 2012;13(4)Supplement:S74.
citation: Aspley S, Schachtel B, Berry P, Shephard A, Shea T, Smith G, Lorton M, Schachtel E. Efficacy and safety of multiple uses of flurbiprofen 8.75mg lozenge over 1 week. Abstract presented at the 14th World Congress on Pain, 27 - 31 August 2012, Milan.
citation: Shephard A, Smith G, Aspley S, Schachtel B. Efficacy of flurbiprofen 8.75 mg lozenges for streptococcal and non-streptococcal sore throat: pooled analysis of two randomised, placebo-controlled studies. Abstract presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), 27 - 30 April 2013, Berlin.
citation: Shephard A, Smith G, Aspley S, Schachtel B. Symptomatic relief in streptococcal and non-streptococcal sore throat patients: pooled analysis of two randomised, placebo-controlled studies. Abstract presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), 27-30 April 2013, Berlin.
citation: Schachtel B, Aspley S, Berry P, Shephard A, Sanner K, Shea T, Smith G, Schachtel E. Chief Complaint: the therapeutogenic stimulus as the primary, individualized endpoint in clinical trials. Journal of Pain 2012;13(4)Supplement:S6.
citation: Shephard A, Smith G, Aspley S, Schachtel BP. Randomised, double-blind, placebo-controlled studies on flurbiprofen 8.75 mg lozenges in patients with/without group A or C streptococcal throat infection, with an assessment of clinicians' prediction of 'strep throat'. Int J Clin Pract. 2015 Jan;69(1):59-71. doi: 10.1111/ijcp.12536. Epub 2014 Oct 9.
citation: Schachtel B, Aspley S, Shephard A, Shea T, Smith G, Schachtel E. Utility of the sore throat pain model in a multiple-dose assessment of the acute analgesic flurbiprofen: a randomized controlled study. Trials. 2014 Jul 3;15:263. doi: 10.1186/1745-6215-15-263.