A clinical study to assess the effectiveness of Strepsils sore throat lozenges
| ISRCTN | ISRCTN00003567 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00003567 |
| Secondary identifying numbers | TH0817 |
- Submission date
- 12/05/2010
- Registration date
- 20/05/2010
- Last edited
- 29/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Alan Wade
Scientific
Scientific
CPS Research
3 Todd Campus
West of Scotland Science Park
Glasgow
G20 0XA
United Kingdom
Study information
| Study design | Randomised single dose placebo controlled parallel group design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A multicentre, randomised, double blind, placebo-controlled, parallel group, single dose study of the efficacy of two flavour variants of Strepsils throat lozenges in the relief of sore throat due to upper respiratory tract infection |
| Study hypothesis | Do Strepsils lozenges improve sore throat symptoms over 2 hours? |
| Ethics approval(s) | Fife, Forth Valley and Tayside Research Ethics Service approved on the 15th December 2008 (ref: FB/08/S0501/91) |
| Condition | Sore throat |
| Intervention | 1. Strepsils lozenge (0.6 mg 2,4-dichlorobenzylalcohol, 1.2 mg amylmetacresol) single dose, oral 2. Placebo lozenge, single dose, oral This trial is of a single dose with a 2 hour follow up only. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Strepsils throat lozenges |
| Primary outcome measure | Area under the change from baseline curve (AUC) in severity of throat soreness, from 0 to 2 hours (using 11 point categorical throat soreness scale) |
| Secondary outcome measures | 1. Change from baseline in severity of throat soreness (using the 11 point throat soreness scale) at 1,5, 10, 15, 30, 45, 60, 75, 90, 105 and 120 minutes post-dose 2. Onset of analgesia defined as time to first reporting 'moderate pain relief' (which is the midpoint on the 7 point sore throat relief scale) 3. Total sum of pain relief ratings: defined as the AUC from baseline to 2 hours post first dosing for sore throat relief 4. Sore throat relief at 1, 5, 10, 15, 30, 45, 60, 75, 90, 105 and 120 minutes post-dose 5. AUC from baseline to 2 hours for the change from baseline in difficulty swallowing 6. Change from baseline in difficulty in swallowing at 1, 5, 10, 15, 30, 45, 60, 75, 90, 105 and 120 minutes post-dose 7. AUC for throat numbness measurements from 1 to 120 minutes 8. Throat numbness at 1, 5, 10, 15, 30, 45, 60, 75, 90, 105 and 120 minutes post-dose 9. Overall treatment rating at 2 hours 10. Responses to the questions from the consumer questionnaire |
| Overall study start date | 12/01/2009 |
| Overall study end date | 20/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 225 |
| Participant inclusion criteria | 1. Aged greater than or equal to 16 to less than or equal to 75 years 2. Male and female patients 3. Primary diagnosis: patients with sore throat of onset within the past 4 days (i.e. less than or equal to 4 days) due to upper respiratory tract infection (URTI) 4. Patients who had a sore throat (greater than or equal to 6) on the Throat Soreness Scale at baseline 5. Objective findings that confirm the presence of tonsillopharyngitis (greater than or equal to 3 points on the expanded 21-point Tonsillopharyngitis Assessment) 6. Patients who gave written informed consent |
| Participant exclusion criteria | 1. Any previous history of allergy or known intolerance to the study drug or the following formulation constituents: amylmetacresol (AMC), 2,4-dichlorobenzyl alcohol (DCBA), anise oil, peppermint oil, natural menthol, menthol synthetic, xylitol, mint, eucalyptus oil, liquid sucrose, liquid glucose, tartaric acid gran 571 GDE, ponceau 4R, edicol E124, carmoisine edicol E122, sugar, cream, anthocyanin, ginger, wasabi, blackcurrant and plum 2. Those whose sore throat had been present for more than 4 days 3. Those who had evidence of mouth breathing 4. Those who had evidence of severe coughing 5. Those who had any disease that could compromise breathing, e.g., bronchopneumonia 6. Those who had taken any medicated confectionary, throat pastille, spray, or any product with demulcent properties such as boiled sweets in the previous two hours 7. Those who had used any sore throat medication containing a local anaesthetic within the past 4 hours 8. Those who had used any analgesic, antipyretic or cold medication (e.g., decongestant, antihistamine, antitussive or throat lozenge) within the previous 8 hours 9. Those who have used a longer acting or slow release analgesic during the previous 24 hours, e.g., piroxicam and naproxen 10. Those taking antibiotics during the previous 14 days 11. Those with any painful condition that may have distracted attention from sore throat pain, e.g., mouth ulcers, etc. 12. Those with a history of severe renal impairment 13. Those with a history of severe hepatic impairment 14. Those with a history of alcohol abuse or who stated that they regularly consume alcohol in excess of the recommended amounts (excessive alcohol greater than 21 units per week for females and greater than 28 units per week for males) 15. Those unable to refrain from smoking during their stay in the investigative site 16. Women of childbearing potential, who reported they were pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions (i.e., an oral or injectable contraceptive, an approved hormonal implant or topical patch or an intrauterine device). Adequate contraception should also include abstinence, barrier contraception and partner vasectomy. A women of childbearing potential was 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). 17. Those previously randomised into the study 18. Those who have participated in a clinical trial in the previous 30 days. Thirty days were calculated from time of last dosing in the prior trial to time of anticipated dosing in this trial. 19. Those unable in the opinion of the investigator to comply fully with the study requirements, e.g., such as those who could not comprehend or correctly use the pain rating scales |
| Recruitment start date | 12/01/2009 |
| Recruitment end date | 20/02/2009 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
CPS Research
Glasgow
G20 0XA
United Kingdom
G20 0XA
United Kingdom
Sponsor information
Reckitt Benckiser Healthcare (UK)
Industry
Industry
Dansom Lane
Hull
HU8 7DS
United Kingdom
| Website | http://www.rb.com/home |
|---|---|
"ROR" |
https://ror.org/01g87hr29 |
Funders
Funder type
Industry
Reckitt Benckiser Healthcare (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/02/2011 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
