Sore throat suitable for treatment in an OTC setting.
Conditions
Interventions
Trade Name: Strefen lozenge
Product Name: Strefen honey & lemon lozenge
Pharmaceutical Form: Lozenge
INN or Proposed INN: Flurbiprofen
C
Sponsors
Boots Healthcare International Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed