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HealthyPhase 1NCT03706781

A Novel Mouthwash Formulation CTP/BNZ With Mucus Adhesive Polymer

A Phase 1 study testing Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15% + mucus adhesive polymer and Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15% in people with Healthy, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15% + mucus adhesive polymer and Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteSwitzerland
Study dates
14 Nov 2017to 30 Mar 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Informed consent: signed written informed consent before inclusion in the study
  • Sex and Age: males/females, 18-55 year old inclusive
  • Body Mass Index: 18.5-30 kg/m2 inclusive
  • 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
  • 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
  • Contraception and fertility (women only): women of child-bearing potential must be using at least one of the following reliable methods of contraception:
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  • Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit
  • 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
  • A male sexual partner who agrees to use a male condom with spermicide
  • 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.

Who cannot join

  • Electrocardiogram (ECG) 12-leads (supine position): clinically significant abnormalities
  • Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
  • Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
  • 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
  • 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
  • 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
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  • 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
  • Blood donation: blood donations for 3 months before this study
  • 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)
  • Drug test: positive result at the drug test at screening or Day -1
  • Alcohol test: positive alcohol breath test at Day -1
  • Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
  • Pregnancy (females only): positive or missing pregnancy test at screening or Days -1 or 6, pregnant or lactating women

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

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

    Arzo, CH-6864

Other trials in Switzerland

About this study

Official title: 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.

Conditions
Healthy
Being tested
Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15% + mucus adhesive polymer, Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15%
Keywords
Phase I, Local tolerability, Systemic Availability, Cetylpyridinium chloride 0.05%, Benzydamine hydrochloride 0.15%, Mucoadhesive polymer, Tantum Verde Bocca

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15% + mucus adhesive polymerDrug

    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

  • Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15%Drug

    Also called Tantum verde bocca

    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

Study groups in NCT03706781
Study groupRoleWhat they receive
Test product CTP/BNZ with mucus adhesive polymerExperimentalA 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.
Receives: Drug: Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15% + mucus adhesive polymer
Reference product CTP/BNZ - Tantum Verde BoccaActive comparatorA 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.
Receives: Drug: Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Local Adverse Reactions (ADRs)

    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.

    Measured: Change before and after each administration up to Day 8

Secondary outcomes (4)

  1. Systemic availability of benzydamine (free base) through Cmax.

    Systemic availability of benzydamine (free base) by measurement of plasma concentrations.

    Measured: 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.

  2. Systemic availability of benzydamine (free base) through AUC(0-t).

    Systemic availability of benzydamine (free base) by measurement of area under the plasma concentration-time curve [AUC(0-t)].

    Measured: 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.

  3. Incidence of AEs

    General tolerability and safety of the study products assessed through monitoring of AEs including clinically significant abnormalities in laboratory assays (haematology, blood chemistry, urinalysis).

    Measured: Through study completion, an average of three weeks

  4. Palatability

    Organoleptic properties of the study products evaluated through a ORGANOLEPTIC AND EASE OF USE CHARACTERISTICS questionnaire.

    Measured: Day 7 (after the last dose of each study period).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2018
  2. Study start14 Nov 2017
  3. Primary completion18 Dec 2017
  4. Study completion30 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03706781
Sponsor's protocol ID
030(1C)WO17048
Status last verified
Aug 2020
First submitted
27 Apr 2018
Last updated
5 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15% + mucus adhesive polymer and Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15% in people with Healthy, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Local Adverse Reactions (ADRs) (time frame: Change before and after each administration up to Day 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03706781.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.

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