A Novel Mouthwash Formulation CTP/BNZ With Mucus Adhesive Polymer

August 3, 2020 updated by: Aziende Chimiche Riunite Angelini Francesco S.p.A

A Phase I Study of a Novel Mouthwash Formulation (Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15% + Mucus - Adhesive Polymer) Administered Twice a Day for 7 Days to Healthy Subjects in Comparison With Marketed Tantum Verde Bocca Mouthwash Solution

The purpose of the study is to evaluate the local tolerability and the systemic availability of benzydamine, if any, after single and multiple dose treatment with the test formulation containing cetylpyridinium chloride 0.05% + benzydamine hydrochloride 0.15% + mucoadhesive polymer and with the reference formulation Tantum Verde Bocca containing cetylpyridinium chloride 0.05% + benzydamine hydrochloride 0.15% to healthy subjects , under fasting conditions, in two consecutive study periods.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Arzo, Switzerland, CH-6864
        • CROSS Research S.A., Phase I Unit, Via F.A. Giorgioli 14 Phone: Fax: +41.91.63.00.511 Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Informed consent: signed written informed consent before inclusion in the study
  2. Sex and Age: males/females, 18-55 year old inclusive
  3. Body Mass Index: 18.5-30 kg/m2 inclusive
  4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position
  5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the study

  6. Contraception and fertility (women only): women of child-bearing potential must be using at least one of the following reliable methods of contraception:

    1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit
    2. A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit
    3. A male sexual partner who agrees to use a male condom with spermicide
    4. A sterile sexual partner Women of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted.

For all women, pregnancy test result must be negative at screening.

Exclusion Criteria:

  1. Electrocardiogram (ECG) 12-leads (supine position): clinically significant abnormalities
  2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
  3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
  4. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
  5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; mouth lesions or any other oral mucosa alteration that may interfere with the aim of the study according to the investigator's opinion
  6. Medications: any medications (topical or systemic), including over the counter (OTC) medications, oral rinses and herbal remedies for 2 weeks before the start of the study. Hormonal contraceptives for females will be allowed
  7. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
  8. Blood donation: blood donations for 3 months before this study
  9. Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>1 drink/day for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2015], caffeine (>5 cups coffee/tea/day) or tobacco abuse (≥10 cigarettes/day)
  10. Drug test: positive result at the drug test at screening or Day -1
  11. Alcohol test: positive alcohol breath test at Day -1
  12. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
  13. Pregnancy (females only): positive or missing pregnancy test at screening or Days -1 or 6, pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test product CTP/BNZ with mucus adhesive polymer
A multiple dose of the Cetylpyridinium Chloride 0.05%+Benzydamine HCl 0.15% (CTP/BNZ) + mucus adhesive polymer is administered to healthy subjects twice a day for 7 days, under fasting conditions in two subsequent periods according to the randomised cross-over design.
Drug: Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15% + mucus adhesive polymer
Test product will be applied twice a day (b.i.d) every 12 h once in the morning and once in the evening for 6 consecutive days (from Day 1 to Day 6) and once in the morning on Day 7 for a total of 13 dose
Active Comparator: Reference product CTP/BNZ - Tantum Verde Bocca
A multiple dose of the Cetylpyridinium Chloride 0.05%+Benzydamine HCl 0.15% (CTP/BNZ) Tantum Verde Bocca is administered to healthy subjects twice a day for 7 days, under fasting conditions in two subsequent periods according to the randomised cross-over design.
Drug: Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15%
Reference Product will be applied twice a day (b.i.d) every 12 h once in the morning and once in the evening for 6 consecutive days (from Day 1 to Day 6) and once in the morning on Day 7 for a total of 13 dose
Other Names:
  • Tantum verde bocca

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Local Adverse Reactions (ADRs)
Time Frame: Change before and after each administration up to Day 8
Local ADRs reported by the subjects through a 4-point scale according to a local tolerability scale (degree of severity of reactions from 0 to 3. 0=none; 1=mild 2= moderate; 3= severe) as 0-3 scores for burning sensation, irritation, pruritus, dry mouth, salivary hypersecretion and dysphagia. If the score assigned will be 1, 2 or 3, the local AE will classified as a TEAE of mild, moderate or severe severity, respectively.
Change before and after each administration up to Day 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Systemic availability of benzydamine (free base) through Cmax.
Time Frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 h after the first dose. Days 7-8: pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24 h after the last dose.
Systemic availability of benzydamine (free base) by measurement of plasma concentrations.
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 h after the first dose. Days 7-8: pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24 h after the last dose.
Systemic availability of benzydamine (free base) through AUC(0-t).
Time Frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 h after the first dose. Days 7-8: pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24 h after the last dose.
Systemic availability of benzydamine (free base) by measurement of area under the plasma concentration-time curve [AUC(0-t)].
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 h after the first dose. Days 7-8: pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24 h after the last dose.
Incidence of AEs
Time Frame: Through study completion, an average of three weeks
General tolerability and safety of the study products assessed through monitoring of AEs including clinically significant abnormalities in laboratory assays (haematology, blood chemistry, urinalysis).
Through study completion, an average of three weeks
Palatability
Time Frame: Day 7 (after the last dose of each study period).
Organoleptic properties of the study products evaluated through a ORGANOLEPTIC AND EASE OF USE CHARACTERISTICS questionnaire.
Day 7 (after the last dose of each study period).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aziende Chimiche Riunite Angelini Francesco S.p.A

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cross Research S.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Milko Radicioni, Cross Research S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 030(1C)WO17048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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