A single centre, randomised, single (patient) blind, single dose, parallel group exploratory study to compare the efficacy of an 8.75mg flurbiprofen lozenge (Strefen) with a 3mg benzydamine lozenge (Difflam) following oral administration in 200 subjects with sore throat. - Comparator study of Strefen and Difflam

Phase 1

• Conditions: Sore throat suitable for treatment in an OTC setting.

• Registration Number: EUCTR2005-003588-22-GB
• Lead Sponsor: Boots Healthcare International Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-06
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

Only subjects to whom all of the following conditions apply will be included:
1) Age 18 to 65 years
2) Sex: Male and female subjects are eligible for entry.
3) Primary diagnosis: Sore throat of <7 days duration, rated as moderate to severe on a subjective rating scale.
4) Status: subjects will be members of the public who respond to advertising about the study.
5) Subjects who have given written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects to whom any of the following conditions apply must be excluded:
1) Hypersensitivity to any of the constituents, aspirin or other non-steroidal anti-inflammatory drugs (NSAIDS).
2) Subjects with existing, or history of peptic ulceration.
3) Subjects with a history of bronchospasm, rhinitis or urticaria associated with aspirin or other NSAIDS.
4) Subjects with existing, or history of bronchial asthma.
5) Subjects with hereditary fructose intolerance, glucose-galactose malabsorption syndrome or saccharose-isomaltose insufficiency.
6) Subjects with renal, cardiac or hepatic impairment.
7) Subjects with a potential for abnormal bleeding
8) Subjects with hypertension.
9) Use of a pastille, lozenge, spray or other topical throat treatment within 2 hrs of study entry, any sore throat medication containing a local anaesthetic within 4 hrs of study entry, a short-acting analgesic within 6 hrs of study entry, or any long acting or slow release analgesic within 24 hrs of study entry.
10) Women of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions.
11) Those previously randomised into the study.
12) Subjects holding North American citizenship as the BHI Clinial Trials Insurance does not cover those persons.
13) Those who have participated in a clinical trial in the previous two months.
14) Those unable in the opinion of the investigator to comply fully with the study requirements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of an 8.75mg flurbiprofen lozenge with a 3mg benzydamine lozenge in the treatment of sore throat.;Secondary Objective: To compare the consumer preferences for the 8.75mg flurbiprofen lozenge with a 3mg benzydamine lozenge.;Primary end point(s): The primary variables will be those questions from the assessment questionnaire that reflect the efficacy and duration of action of the formulations.