A randomised, controlled, open-label, single-centre, parallel group,pilot study to investigate the onset of action of a lozenge comparedwith a caplet in patients with sore throat. - Strepsils onset of action study

• Conditions: patients with sore throat; MedDRA version: 9.1Level: LLTClassification code 10041367Term: Sore throat

• Registration Number: EUCTR2006-006769-17-GB
• Lead Sponsor: Reckitt Benckiser Healthcare International Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1)Age: Patients aged 16 to 65 years of age are eligible to participate.
2)Sex: Both males and females are eligible for entry
3)Primary diagnosis: All patients selected for this study will have a sore throat due to upper respiratory tract infection. In addition they will have a TPA score of = 5 (range 0 – 21), a throat soreness scale of = 6 on the 11-point ordinal scale and a difficulty in swallowing score of = 60 mm on the 100 mm VAS.
4)Patients who have given written informed consent.

Are the trial subjects under 18? yes
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)A history of allergy (including angioedema, urticaria, bronchospasm and rhinitis) related to treatment with ibuprofen, flurbiprofen, aspirin or other NSAIDs or to formulation constituents, eg
2)A history of peptic ulcers, duodenal ulcers, or gastrointestinal bleeding.
3)A history of frequent dyspepsia, heartburn, or indigestion.
4)Inflammatory bowel disease e.g. Crohn’s or ulcerative colitis, chronic/acute hepatic renal or coagulation disorders that might preclude NSAID use.
5)Severe coughing
6)Those who have used any analgesic, antipyretic or cold” medication (e.g. decongestant, antihistamine, antitussive, or throat lozenge) within the previous 8 hours.
7)Those who have taken any medicated confectionary or products with demulcent properties such as sweets, within the previous 2 hours.
8)Those with any painful condition that may distract attention from sore throat pain e.g. mouth ulcers, etc.
9)Those unable to refrain from smoking during their stay in the research centre.
10)Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. an oral contraceptive, an approved hormonal implant, an intrauterine device or condoms/diaphragm and spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone an hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy).
11)Those previously randomised into this study.
12)Those who have participated in a clinical trial in the previous 30 days. Thirty days are calculated from time of last dosing in the prior trial to time of anticipated dosing in this trial.
13)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