A Study of Flurbiprofen 8.75 mg Lozenge in Patient With Pharyngitis

NCT01049334 | Completed Phase 3 Results DMC

• 1 other identifier: TH 0901
• Study Type: interventional
• Target: 204
• 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

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 -114609 (complete pain relief within 2 minutes of dosing that lasts 24 hours) to 29191 (maximum pain within 2 minutes 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), 24 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2; every 30 minutes until hour 6; and every hour the participant was awake between hours 7-24)

Secondary Outcomes (15)

• 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), 2 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2)

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

  baseline (pre-dose), 2 hours post-dose (every 10 minutes until hour 2)

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

  baseline (pre-dose), 24 hours post-dose (every 10 minutes until hour 2, every 30 minutes until hour 6, hourly from 7-24 hours)

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

  baseline (pre-dose), 2 hours post-dose (at 1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, and 2 hours)

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

  baseline (pre-dose), 24 hours post-dose (1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, 2 hours, 2½ hours, 3 hours, 3½ hours, 4 hours, 4½ hours, 5 hours, 5½ hours, and 6 hours after the first dose, hourly from 7-24 hours)

Study Arms (2)

flurbiprofen 8.75 mg lozenge

EXPERIMENTAL

Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.

Drug: Flurbiprofen

Placebo lozenge

PLACEBO COMPARATOR

Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.

Drug: Placebo

Interventions

Placebo DRUG

Participants were instructed to suck one placebo lozenge during the initial two-hour clinic visit. Upon discharge, participants were instructed to use study medication lozenge every 3-6 hours as needed for pain, up to a total of 5 study lozenges in 24 hours.

Placebo lozenge

Flurbiprofen DRUG

Participants were instructed to suck one flurbiprofen 8.75 mg lozenge during the initial two-hour clinic visit. Upon discharge, participants were instructed to use study medication lozenge every 3-6 hours as needed for pain, up to a total of 5 study lozenges in 24 hours.

flurbiprofen 8.75 mg 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)

University of Connecticut, Student Health Services

Storrs, Connecticut, 06268, United States

Location

Related Publications (15)

• Schachtel BP, McCormick CG and Giefer EE. Patient-reported outcomes (PRO's) in the pharyngitis pain model. Abstract presented at the International Association for the Study of Pain (IASP) Scientific Conference, Montreal, Canada. 2009

  RESULT

• Schachtel BP, Aspley S, Sternberg M, Berry P, Muir N, Sanner K, Rezuke J, Savino L, Shephard A, Shea T, Schachtel E. Onset of demulcent and analgesic activity of flurbiprofen lozenge. Int J Clin Pharm 2012;34:143-258.

  RESULT

• Aspley S, Schachtel B, Berry P, Shephard A, Sanner K, Shea T, Smith G. The Chief Complaint: evidence of its use as an endpoint in a clinical trial. Journal of Pain 2012;13(4)Supplement:S4.

  RESULT

• Aspley S, Schachtel B, Berry P, Shephard A, Sanner K, Savino L, Rezuke J, Shea T, Smith G. Treatment of odynophagia and dysphagia by flurbiprofen 8.75 mg lozenges. Pain Research & Management 2012;17(3):203.

  RESULT

• Schachtel B, Aspley S, Berry P, Shephard A, Shea T,Sanner K, Smith G,Schachtel E. Efficacy of flurbiprofen 8.75mg lozenges in patients with swollen/inflamed sore throat. Abstract presented at the 14th World Congress on Pain, 27 - 31 August 2012, Milan.

  RESULT

• Schachtel B, Aspley S, Berry P, Smith G, Shephard A, Shea T, Schachtel E. A patient-centered method for determining onset of action. Clinical Pharmacology in Drug Development 2012;1(4):194-195.

  RESULT

• Schachtel B, Aspley S, Berry P, Shephard A, Shea T, Smith G, Sanner K, Savino L, Rezuke J, Schachtel E. Efficacy and duration of flurbiprofen 8.75 mg lozenge. Clinical Pharmacology in Drug Development 2012;1(4):194.

  RESULT

• Schachtel B, Aspley S, Berry P, Shephard A, Shea T, Smith G, Schachtel E. A new cough model: de-hawthornizing a clinical trial. Clinical Pharmacology in Drug Development 2012;1(4):195.

  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

• Aspley S, Schachtel B, Berry P, Shephard A, Shea T, Smith G, Schachtel E. Flurbiprofen lozenges in patients with a "bad sore throat". Journal of Pain 2013;14(4):S59.

  RESULT

• Schachtel B, Aspley S, Berry P, Shephard A, Shea T, Smith G, Schachtel E. The "Definite Improvement Level" (DIL) as a determinant of drug efficacy. Journal of Pain 2013;14(4):S5.

  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

• Aspley S, Shephard A, Schachtel E, Sanner K, Savino L, Schachtel B. Efficacy of flurbiprofen 8.75 mg lozenge in patients with a swollen and inflamed sore throat. Curr Med Res Opin. 2016 Sep;32(9):1529-38. doi: 10.1080/03007995.2016.1187119. Epub 2016 May 18.

  PMID: 27146963 DERIVED

• 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

MeSH Terms

Conditions

Pharyngitis

Interventions

Flurbiprofen

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

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)