Evaluation of an Over-The-Counter cough medicine.

A real world, single-blind, randomised study to compare an OTC cough medicine (cs1002) containing diphenhydramine, levomenthol and ammonium chloride with a simple linctus containing citric acid monohydrate in terms of daily cough severity in subjects with acute cough in routine clinical practice. - Real-World evaluation of an OTC cough medicine containing diphenhydramine.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004255-31-GB

Enrollment

180

Registered

2015-06-22

Start date

2014-12-02

Completion date

Unknown

Last updated

2016-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute cough

Interventions

Product Name: cs1002 Product Code: cs1002 Pharmaceutical Form: Oral solution INN or Proposed INN: diphenhydramine hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female subjects aged 18 years or over. Subject has self-referred to the GP or Pharmacist owing to a new onset acute cough with a maximum of 7 days duration and a severity of at least 60 mm on a 0?100 mm visual analogue scale (VAS). Willing and able to give informed consent and of complying with the trial assessments and any other trial procedures. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Pregnant or lactating females. Any relevant hospital stays of more than 2 days, within 6 months before the subject self refers to the GP or Pharmacist (Day 1). NB: An example of a relevant hospital stay would be for respiratory conditions such as ‘lung infection’ or ‘pneumonia’. Current smokers and those who have smoked within the last two months. This includes the use of e-cigarettes. Taken any medication with a cough treatment designation for this cough (whether a prescription drug, an OTC drug or a natural herbal product (e.g. honey, eucalyptus etc.). A productive cough with excessive secretions, regardless of colour. Subjects requiring co-prescription with other treatments for coughs or colds. This includes subjects taking antibiotics. Subjects with known hypersensitivity to any of the ingredients of the study medication. Subjects with chronic cough (i.e. chronic bronchitis in smokers, gastro-oesophageal reflux, asthma, hyper-responsive airways after resolution of respiratory tract infection, COPD, pertussis, aspiration, tumour, tuberculosis or fungal infections). Subjects with prostatic hypertrophy, urinary retention, susceptibility to closed-angle glaucoma, liver disease fructose intolerance, glucose intolerance, glucose-galactose malabsorption, sucrose-isomaltase insufficiency. Subjects taking monoamine oxidase inhibitors (MAOI) or having taken them within 14 days of entering the study and those requiring ongoing treatment with codeine, other anti-histamines, central nervous system depressants, other anticholinergic medicines (e.g. atropine), anti-psychotics or ACE inhibitors. Treatment with any investigational drug agent during the 30 days before enrolment into the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the efficacy of an OTC cough product containing diphenhydramine (cs1002) versus Bell's simple linctus by comparing the change in severity of cough after 3 days of treatment(Day 4).;Secondary Objective: To compare the effectiveness of an over-the-counter cough product containing an antihistamine (diphenhydramine; cs1002) against Bell's simple linctus by comparing change from baseline using the Leicester Cough Questionnaire (LCQ-acute) total scores at Days 4, 6 and 8. To determine the time for cough symptoms to disappear (defined as the day at which cough severity decreases to < 17mm on the scale used). ;Primary end point(s): Change from baseline in cough severity VAS scores after 3 Days of treatment (Day 4).;Timepoint(s) of evaluation of this end point: Cough severity VAS score at Day 4 will be evaluated at the end of the study.	—

Measure

Time frame

Main Objective: To investigate the efficacy of an OTC cough product containing diphenhydramine (cs1002) versus Bell's simple linctus by comparing the change in severity of cough after 3 days of treatment(Day 4).;Secondary Objective: To compare the effectiveness of an over-the-counter cough product containing an antihistamine (diphenhydramine; cs1002) against Bell's simple linctus by comparing change from baseline using the Leicester Cough Questionnaire (LCQ-acute) total scores at Days 4, 6 and 8. To determine the time for cough symptoms to disappear (defined as the day at which cough severity decreases to < 17mm on the scale used). ;Primary end point(s): Change from baseline in cough severity VAS scores after 3 Days of treatment (Day 4).;Timepoint(s) of evaluation of this end point: Cough severity VAS score at Day 4 will be evaluated at the end of the study.

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Secondary

Measure	Time frame
Secondary end point(s): Change from baseline in Leicester cough questionnaire total scores at Day 4, 6 and 8. Change from baseline in cough severity at Day 5, and in cough frequency and sleep quality VAS scores at Day 4, 6 and 8. Time to resolution of cough symptoms defined as the day at which cough severity decreases to <17mm.;Timepoint(s) of evaluation of this end point: Scores from Days 4,5,6 and 8 will be evaluated at the end of the study.	—

Measure

Time frame

Secondary end point(s): Change from baseline in Leicester cough questionnaire total scores at Day 4, 6 and 8. Change from baseline in cough severity at Day 5, and in cough frequency and sleep quality VAS scores at Day 4, 6 and 8. Time to resolution of cough symptoms defined as the day at which cough severity decreases to <17mm.;Timepoint(s) of evaluation of this end point: Scores from Days 4,5,6 and 8 will be evaluated at the end of the study.

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Countries

United Kingdom

Contacts

Public ContactDirector of Regualtory Affairs

infirst HEALTHCARE

viv.edwards@infirst.co.uk02071536600

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026