A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis

NCT01048866 | Completed Phase 3 Results

• 1 other identifier: TH 0913
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharyngitis

Keywords

pharyngitis; swollen throat; difficulty swallowing

Outcome Measures

Primary Outcomes (1)

• Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24)

  STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID24 was calculated as the sum of the time weighted pain intensity differences from baseline until 24 hours. The full range was -104412 (complete pain relief within 1 hour of dosing that lasts 24 hours) to 27588 (maximum pain within 1 hour lasting 24 hours) using the mean baseline STPIS. Participants with a last recorded time point \<21 hours were considered Not Evaluable. If a participant used rescue medication, all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose.

  baseline (pre-dose), post-dose - hourly up to 24 hours

Secondary Outcomes (18)

• Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline

  Baseline (pre-dose), Hours 1 and 2 post-dose

• Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline

  Baseline (pre-dose), hourly readings to 24 hours post-dose

• Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline

  Baseline (pre-dose), hourly readings to 2 hours post-dose

• Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline

  Baseline (pre-dose), hourly readings to 24 hours post-dose

• Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2)

  baseline (pre-dose), post-dose: 1 hour, 2 hours

Study Arms (2)

flurbiprofen 8.75 mg lozenge

EXPERIMENTAL

Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge and efficacy assessments were taken in the clinic. Upon discharge, participants were instructed to use another study medication lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours. Following efficacy assessments, participants were again instructed to use study medication lozenge every 3-6 hours, up to a total of 5 study lozenges per day (plus rescue medication if needed) for the remaining time in the 7 day study.

Drug: flurbiprofen; Drug: acetaminophen 650mg

placebo lozenge

PLACEBO COMPARATOR

Participants were instructed to suck one study (placebo) lozenge and efficacy assessments were taken in the clinic. Upon discharge, participants were instructed to use another lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours. Following efficacy assessments, participants were again instructed to use a lozenge every 3-6 hours, up to a total of 5 study lozenges per day (plus rescue medication if needed) for the remaining time in the 7 day study.

Drug: placebo; Drug: acetaminophen 650mg

Interventions

placebo DRUG

Sugar-based lozenge flavoured to match the active treatment lozenge. Instructions were to suck one lozenge until gone, every 3-6 hours as needed for sore throat pain. The participant took nothing by mouth except study medication during the first two hours while at the site. For each re-dosing during the remaining time in the study, alcohol and caffeine-containing beverages (e.g., coffee, tea, hot chocolate, caffeinated soft drinks) were not consumed within 1 hour before the participant used a study medication lozenge.

placebo lozenge

flurbiprofen DRUG

Sugar-based, flavoured flurbiprofen 8.75 mg lozenge. Instructions were to suck one lozenge until gone, every 3-6 hours as needed for pain. The participant took nothing by mouth except study medication during the first two hours while at the site. For each re-dosing during the remaining time in the study, alcohol and caffeine-containing beverages (e.g., coffee, tea, hot chocolate, caffeinated soft drinks) were not consumed within 1 hour before the participant used a study medication lozenge.

flurbiprofen 8.75 mg lozenge

acetaminophen 650mg DRUG

Rescue medication to be taken as needed. Rescue medication was not blinded.

Also known as: Tylenol

flurbiprofen 8.75 mg lozenge; placebo lozenge

Eligibility Criteria

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

You may qualify if:

• The patient has a complaint of sore throat.
• 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.
• If the patient is a female of childbearing potential, the patient must have a negative urine pregnancy.
• The patient has provided written informed consent prior to any study-related procedures.

You may not qualify if:

• 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).
• The patient has a history of any hepatic disease or renal dysfunction.
• 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.)

Sponsors & Collaborators

• Reckitt Benckiser LLC: lead

Study Sites (1)

Bluestone Center for Clinical Research

New York, New York, 10010, United States

Location

Related Publications (7)

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 25296661 DERIVED

• 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.

  PMID: 24988909 DERIVED

MeSH Terms

Conditions

Pharyngitis; Deglutition Disorders

Interventions

Flurbiprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Gail Solomon, Director, Clinical Development
• Organization: Reckitt Benckiser Inc.

gail.solomon@rb.com

973-404-2752

Study Officials

• Timothy J Shea, BS

  Reckitt Benckiser Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 14, 2010
• Study Start: November 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 21, 2017
• Results First Posted: September 21, 2017

Record last verified: 2017-08

Locations

US (1)