Assessment of Chlorhexidine hydrochloride - Lidocaine hydrochloride (MEDICA ®) efficacy and safety in adult patients with sore throat

Efficacy and safety assessment of Chlorhexidine hydrochloride - Lidocaine hydrochloride (MEDICA ®) versus placebo in adult patients with sore throat and/or acute pharyngitis

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005521-23-DK

Enrollment

202

Registered

2014-03-19

Start date

2014-06-19

Completion date

Unknown

Last updated

2015-02-23

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

Conditions

Sore throat or acute pharyngitis MedDRA version: 17.1 Level: LLT Classification code 10001002 Term: Acute pharyngitis System Organ Class: 100000004862 MedDRA version: 17.1 Level: LLT Classification code 10047479 Term: Viral sore throat System Organ Class: 100000004862

Interventions

Product Name: MEDICA THROAT TABLETS Pharmaceutical Form: Compressed lozenge INN or Proposed INN: Chlorhexidine dihydrochloride CAS Number: 3697-42-5 Current Sponsor code: Chlorhexidine hydrochloride 5

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Disease related: - Non-bacterial pharyngitis and/or erythematous sore throat since less than 3 days - Mac Isaac Score =65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Disease related: - Presence of peritonsillar or retropharyngeal abscess - Pseudo-membranous pharyngitis - Other causes of dysphagia and/or pharyngitis Treatment related: - Oral, local or injection antibiotic administration within the last 14 days preceding the enrolment - Oral or local steroidal or non-steroidal anti-inflammatory drugs within the last 48 hours preceding the enrolment Population related: - Pregnant women - Breast feeding women - Women in childbearing age not using an effective contraceptive method (hormonal or mechanical) - Inability to comply with the protocol - Linguistic or physiological inability to sign the informed consent form - Participation in a clinical trial during the previous three months

Design outcomes

Primary

Measure	Time frame
Main Objective: - To evaluate and compare the efficacy of MEDICA® (Chlorhexidine Hydrochloride/Lidocaine Hydrochloride) versus placebo from baseline at 2 hours in the management of sore throat and dysphagia in adult patients with non-bacterial pharyngitis. - To evaluate the safety during the study follow-up and at day 7 using a phone call.;Secondary Objective: - To evaluate and compare the effect of MEDICA® in throat pain relief at 2 hours after first dose, - To evaluate and compare the efficacy of MEDICA® versus placebo from baseline at Day 4 in the management of sore throat and dysphagia, - To evaluate quality of life as regards sleeping, eating, reading and speaking at each day from day 1 to day 4.;Primary end point(s): - The comparison between the 2 groups (MEDICA vs. Placebo) in area under the curve (AUC) of sore throat and of dysphagia between T0 and T120;Timepoint(s) of evaluation of this end point: 2 hours after the first drug intake	—

Measure

Time frame

Main Objective: - To evaluate and compare the efficacy of MEDICA® (Chlorhexidine Hydrochloride/Lidocaine Hydrochloride) versus placebo from baseline at 2 hours in the management of sore throat and dysphagia in adult patients with non-bacterial pharyngitis. - To evaluate the safety during the study follow-up and at day 7 using a phone call.;Secondary Objective: - To evaluate and compare the effect of MEDICA® in throat pain relief at 2 hours after first dose, - To evaluate and compare the efficacy of MEDICA® versus placebo from baseline at Day 4 in the management of sore throat and dysphagia, - To evaluate quality of life as regards sleeping, eating, reading and speaking at each day from day 1 to day 4.;Primary end point(s): - The comparison between the 2 groups (MEDICA vs. Placebo) in area under the curve (AUC) of sore throat and of dysphagia between T0 and T120;Timepoint(s) of evaluation of this end point: 2 hours after the first drug intake

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Secondary

Measure	Time frame
Secondary end point(s): - The change from baseline in sore throat relief (using a 7-point scale) at 120 minutes after the first dose. - The comparison between the 2 groups of Day1 to Day 4 for : o The evolution of VAS score as regards sore throat o The evolution of VAS score as regards dysphagia (swallowing troubles) - The comparison of the response to the treatment (as a reduction at D4 by 50% of the TSS baseline score) of the two groups. - Evaluation of quality of life (sleeping, eating, reading, speaking) in patient self-assessment questionnaire - Evaluation of overall acceptability of product by investigator - Assessment of local tolerance by investigator using a 4-point scale - Evaluation of the adverse events reported during the study;Timepoint(s) of evaluation of this end point: 2 hours after the first drug intake and at day 4	—

Measure

Time frame

Secondary end point(s): - The change from baseline in sore throat relief (using a 7-point scale) at 120 minutes after the first dose. - The comparison between the 2 groups of Day1 to Day 4 for : o The evolution of VAS score as regards sore throat o The evolution of VAS score as regards dysphagia (swallowing troubles) - The comparison of the response to the treatment (as a reduction at D4 by 50% of the TSS baseline score) of the two groups. - Evaluation of quality of life (sleeping, eating, reading, speaking) in patient self-assessment questionnaire - Evaluation of overall acceptability of product by investigator - Assessment of local tolerance by investigator using a 4-point scale - Evaluation of the adverse events reported during the study;Timepoint(s) of evaluation of this end point: 2 hours after the first drug intake and at day 4

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Countries

Denmark, Georgia

Contacts

Public ContactQuanta Medical GROUP

Quanta Medical

m.hanna@quanta-medical.com

Outcome results

None listed

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