Assessment of Chlorhexidine hydrochloride - Lidocaine hydrochloride (MEDICA ®) efficacy and safety in adult patients with sore throat
- Conditions
- Sore throat or acute pharyngitisMedDRA version: 17.1Level: LLTClassification code 10001002Term: Acute pharyngitisSystem Organ Class: 100000004862MedDRA version: 17.1Level: LLTClassification code 10047479Term: Viral sore throatSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2013-005521-23-DK
- Lead Sponsor
- QUALIPHAR NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 202
Disease related:
- Non-bacterial pharyngitis and/or erythematous sore throat since less than 3 days
- Mac Isaac Score < 2
- Negative Rapid Strep Test (RST)
- Tonsillopharyngitis Severity Score (TSS) = 5
Population related:
- Age over 18 years old
- Written informed consent for the study participation
Are the trial subjects under 18? no
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 202
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>- 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,<br>- To evaluate and compare the efficacy of MEDICA® versus placebo from baseline at Day 4 in the management of sore throat and dysphagia,<br>- 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
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - The change from baseline in sore throat relief (using a 7-point scale) at 120 minutes after the first dose.<br>- The comparison between the 2 groups of Day1 to Day 4 for :<br> oThe evolution of VAS score as regards sore throat<br> oThe evolution of VAS score as regards dysphagia (swallowing troubles)<br>- The comparison of the response to the treatment (as a reduction at D4 by 50% of the TSS baseline score) of the two groups. <br>- Evaluation of quality of life (sleeping, eating, reading, speaking) in patient self-assessment questionnaire<br>- Evaluation of overall acceptability of product by investigator<br>- Assessment of local tolerance by investigator using a 4-point scale<br>- 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