Dental CariesPhase 2NCT02594254

Phase 2 Study to Evaluate the Microbiology and Safety of C16G2 Administered to Adult and Adolescent Dental Subjects

A Phase 2 study testing C16G2 Gel in people with Dental Caries, run by Armata Pharmaceuticals, Inc. at 10 sites in United States.

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 this study is to evaluate if C16G2 Gel administered over a certain period of time either with a toothbrush or a custom dental tray can effectively kill bacteria in the mouth that cause dental cavities. Read more about this study

Who is it for?: Ages 12 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Dental Caries
What is being tested?: C16G2 Gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 135 participants
Where: 10 sitesUnited States
Study dates: Nov 2015to Sep 2016
Phase: Phase 2
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 12 to 75 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Males and females, 12-75 years of age, inclusive, at the time the Assent and/or Informed Consent Form is signed
Female subjects of childbearing potential, defined as not surgically sterile or at least two (2) years postmenopausal, must agree to use one of the following forms of contraception from screening through the last study visit: hormonal (oral, implant, or injection) begun >30 days prior to screening; barrier (condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD). Acceptable contraceptive options may also include abstinence, relationship with same sex partner or partner who has had a vasectomy at least six (6) months prior to the screening visit
Male subjects only: willing to use contraception or abstain from sexual activity beginning with the first exposure to study drug and continuing until discharged from the study due to completion or Early Termination
Healthy, as determined by the Investigator (in consultation with the Medical Monitor, as needed), based on medical and dental history, concurrent illnesses, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (extraoral, head and neck) during Screening Note: Subjects on a stable dose of medication may be eligible for screening and will be assessed by the Medical Monitor on a case-by-case basis.
Have a minimum of 12 bicuspids and molars with a minimum of 8 molars and bicuspids NOT having restorations, crowns, sealants
Demonstrated ability to expectorate ≥2 mL of stimulated saliva in 5 minutes

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Have a salivary S. mutans of 1.0 x 10^5 colony forming units (CFUs)/mL or greater at Screening using mitis salivarius-bacitracin (MSB) agar plating
Willing to refrain from using non-study dentifrice and other non-study oral care products (oral care rinses, fluoride products, etc.) during the study
Willing to postpone elective dental procedures (e.g., dental cleanings) between Screening and final post-treatment visit (End of Study or Early Termination)
Willing and able to comply with oral hygiene and diet instructions
Has dentition adequate for custom dental tray gel application
Able to understand and sign the Assent and/or Informed Consent Form prior to initiation of study procedures
Able to communicate with the Investigator/study center personnel, understand and comply with the study requirements, and willing to return for protocol-specified visits at the appointed times

Who cannot join

Advanced periodontal disease
Active caries lesion(s) within 30 days prior to study drug administration (confirmed by comprehensive caries examination including standard radiographs if deemed necessary by the Investigator) Note: Subjects presenting with insipient, non-cavitated lesion(s) are not excluded
Medical condition (e.g., artificial heart valve, history of infective endocarditis, cardiac transplant with valvular dysfunction, congenital heart disease or total joint replacement) for which antibiotics are recommended prior to dental visits and/or procedures
Pathologic lesions of the oral cavity (suspicious or confirmed)
Full dentures or orthodontic appliances, e.g., braces; Note: partial dentures, removable retainers and night guards are not excluded, provided that they are cleaned regularly throughout the duration of the study.
Use of systemic antibiotics, topical oral antibiotics, or use of other drugs, which in the opinion of the Investigator could influence the study outcome, within 30 days prior to Screening and throughout the entire study.

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Medical history indicating the woman is pregnant, breastfeeding/lactating or has a positive urine pregnancy test
Participation in a clinical trial or receipt of a non-FDA approved therapy within 30 days prior to study drug administration (depending on the specifics, participation in an observational study is not necessarily excluded)
Prior participation in a C16G2 clinical trial and known to have received C16G2 active gel or mouth rinse Note: Placebo subjects are not excluded
Presence of any condition or concurrent illness, which in the opinion of the Investigator, would compromise normal immune function (e.g., diabetes, rheumatoid arthritis, lupus, liver disease, organ transplant, etc.), interfere with the use of study dentifrice and oral care products, or interfere with the ability to comply with study requirements, or jeopardize the safety of the subject or the validity of the study results

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Tufts University
Boston, Massachusetts, 02111
Texas Baylor College of Dentistry
Dallas, Texas, 75246
East Carolina University
Greenville, North Carolina, 27834
Imperial Beach Family Dentistry
Imperial Beach, California, 91932
Indiana University School of Dentistry
Indianapolis, Indiana, 46202
Anthony Henegar, DDS, PA
Irving, Texas, 75063
John F. Pittaway, DMD
Kalispell, Montana, 59901
Plaza West II Dental Group
Kalispell, Montana, 59901
New York University College of Dentistry
New York, New York, 10010
University of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Phase 2, Double-Blind, Placebo-Controlled and Open-Label Multi-Center Study to Evaluate the Microbiology and Safety of C16G2 Administered in Multiple Oral Gel Doses to Adult and Adolescent Dental Subjects

Read the detailed description

This multi-center, multiple-arm study will evaluate the microbiological activity and safety of C16G2 Gel in male and female dental subjects, 12 to 75 years of age. The study will be conducted in a randomized, double-blind, placebo-controlled and open-label manner and enroll adolescent (12-17 years of age) and adult subjects (18-75 years of age).

A total of approximately 128 study subjects will be enrolled into up to 7 study arms. Study drug (C16G2 Gel or Placebo) will be administered via manual brush gel application (MBGA) or tray gel application (TGA). Two C16G2 concentrations will be evaluated. Four study arms will be conducted in a double blind manner, with a treatment allocation ratio of 4:1 (C16G2:Placebo), three study arms will be conducted in an open-label manner. Before dosing, eligible subjects will undergo professional dental prophylaxis on Day 0. Clinic visits for all study arms will include Visit 1 (Screening/Days -21 to 0), and a varying number of dosing and follow-up visits.

Conditions: Dental Caries
Being tested: C16G2 Gel, Placebo
Medical subject headings: Dental Caries

What participants receive

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

C16G2 GelDrug
Also called Antimicrobial peptide
Antimicrobial peptide
PlaceboOther
Placebo

Study groups in NCT02594254
Study group	Role	What they receive
Study Arm 1	Experimental	Subjects in Study Arm 1 will receive 4 ml of 800 µM study drug administrations for a total of 28 consecutive days. Subjects will receive 4 C16G2 Gel or placebo administrations at the clinic on the first day, followed by morning (AM) and evening (PM) study drug administrations at the subjects' home for 27 consecutive days. Study drug will be administered via a manual brush. Receives: Drug: C16G2 Gel; Other: Placebo
Study Arm 2	Experimental	Subjects in Study Arm 2 will receive 4 ml of 800 µM study drug administrations for a total of 28 consecutive days. Subjects will receive 4 C16G2 Gel or placebo administrations at the clinic on the first day, followed by morning (AM) and evening (PM) study drug administrations at the subjects' home for 27 consecutive days. Study drug will be administered via a manual brush and custom dental trays. Receives: Drug: C16G2 Gel; Other: Placebo
Study Arm 3	Experimental	Subjects in open-label Study Arm 3 will receive 4 ml of 1600 µM study drug administrations for a total of 7 consecutive days. Subjects will receive 4 C16G2 Gel administrations at the clinic on the first day, followed by morning (AM) and evening (PM) study drug administrations at the clinic for 6 consecutive days. Study drug will be administered via a manual brush and custom dental trays. Receives: Drug: C16G2 Gel
Study Arm 4	Experimental	Subjects in open-label Study Arm 4 will receive 4 ml 800 µM C16G2 Gel on a single day. Subjects will receive 4 study drug administrations at the clinic. Study drug will be administered via manual toothbrush and custom dental trays. Receives: Drug: C16G2 Gel
Study Arm 5	Experimental	Subjects in open-label Study Arm 4 will receive 4 ml of 1600 µM C16G2 Gel on a single day. Subjects will receive 4 study drug administrations at the clinic. Study drug will be administered via manual toothbrush and custom dental trays. Receives: Drug: C16G2 Gel
Study Arm 6	Experimental	If initiated, subjects in Study Arm 6 will receive 4 ml of 1600 µM study drug over a 7 day study drug administration period. Subjects will receive 4 C16G2 Gel or placebo administrations on the first day of dosing followed by morning (AM) and evening (PM) dosing for 6 consecutive days. Study drug will be administered via manual toothbrush and custom dental trays. Receives: Drug: C16G2 Gel; Other: Placebo
Study Arm 7	Experimental	If initiated, subjects in Study Arm 7 will receive 4 ml of 800 µM or 1600 µM study drug on a single day once a week or once a month for a total of 4 days of C16G2 Gel or placebo administration. Subjects will receive 4 study drug administrations on the day of dosing. Study drug will be administered via manual toothbrush and custom dental trays. Receives: Drug: C16G2 Gel; Other: Placebo

What is being measured

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

Antimicrobial Activity of C16G2
To assess the targeted antimicrobial activity of C16G2 Gel applications as measured by a reduction in Streptococcus mutans in saliva and dental plaque
Measured: Evaluated over up to 5 months
Total Oral Bacterial Levels
Total bacterial levels will be evaluated by measuring cfu/ml counts of salivary and plaque bacteria
Measured: Evaluated 7 days post last study drug administration
Safety of C16G2 Gel Administrations assessed by performing targeted physical examinations, oral cavity exams, taking vital signs and collection of adverse events
Safety will be assessed by performing targeted physical examinations, oral cavity exams, taking vital signs and collection of adverse events
Measured: Up to 7 days post last study drug administration

Timeline

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

Nov 2015Sep 2016

First posted3 Nov 2015 (estimated)
Study startNov 2015
Primary completionJun 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Dental CariesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02594254
Sponsor's protocol ID: C3J15-203-00
Status last verified: Jul 2019
First submitted: 28 Oct 2015
Last updated: 1 Aug 2019
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Double-Blind, Placebo-Controlled and Open-Label Multi-Center Study to Evaluate the Microbiology and Safety of C16G2 Administered in Multiple Oral Gel Doses to Adult and Adolescent Dental Subjects
ClinicalTrials.gov ID: NCT02594254
Acronym / sponsor ID: C3J15-203-00
Conditions: Dental Caries
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: Armata Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Collaborators: Vantage Data Designs, Inc., SynteractHCR, Agility Clinical, Inc.
Study start: Nov 2015
Primary completion: Jun 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 3 Nov 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
Study Arm 1	Experimental	Drug: C16G2 Gel, Other: PlaceboSubjects in Study Arm 1 will receive 4 ml of 800 µM study drug administrations for a total of 28 consecutive days. Subjects will receive 4 C16G2 Gel or placebo administrations at the clinic on the first day, followed by morning (AM) and evening (PM) study drug administrations at the subjects' home for 27 consecutive days. Study drug will be administered via a manual brush.
Study Arm 2	Experimental	Drug: C16G2 Gel, Other: PlaceboSubjects in Study Arm 2 will receive 4 ml of 800 µM study drug administrations for a total of 28 consecutive days. Subjects will receive 4 C16G2 Gel or placebo administrations at the clinic on the first day, followed by morning (AM) and evening (PM) study drug administrations at the subjects' home for 27 consecutive days. Study drug will be administered via a manual brush and custom dental trays.
Study Arm 3	Experimental	Drug: C16G2 GelSubjects in open-label Study Arm 3 will receive 4 ml of 1600 µM study drug administrations for a total of 7 consecutive days. Subjects will receive 4 C16G2 Gel administrations at the clinic on the first day, followed by morning (AM) and evening (PM) study drug administrations at the clinic for 6 consecutive days. Study drug will be administered via a manual brush and custom dental trays.
Study Arm 4	Experimental	Drug: C16G2 GelSubjects in open-label Study Arm 4 will receive 4 ml 800 µM C16G2 Gel on a single day. Subjects will receive 4 study drug administrations at the clinic. Study drug will be administered via manual toothbrush and custom dental trays.
Study Arm 5	Experimental	Drug: C16G2 GelSubjects in open-label Study Arm 4 will receive 4 ml of 1600 µM C16G2 Gel on a single day. Subjects will receive 4 study drug administrations at the clinic. Study drug will be administered via manual toothbrush and custom dental trays.
Study Arm 6	Experimental	Drug: C16G2 Gel, Other: PlaceboIf initiated, subjects in Study Arm 6 will receive 4 ml of 1600 µM study drug over a 7 day study drug administration period. Subjects will receive 4 C16G2 Gel or placebo administrations on the first day of dosing followed by morning (AM) and evening (PM) dosing for 6 consecutive days. Study drug will be administered via manual toothbrush and custom dental trays.
Study Arm 7	Experimental	Drug: C16G2 Gel, Other: PlaceboIf initiated, subjects in Study Arm 7 will receive 4 ml of 800 µM or 1600 µM study drug on a single day once a week or once a month for a total of 4 days of C16G2 Gel or placebo administration. Subjects will receive 4 study drug administrations on the day of dosing. Study drug will be administered via manual toothbrush and custom dental trays.

Who may qualify

Ages: 12 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (13 listed)

Males and females, 12-75 years of age, inclusive, at the time the Assent and/or Informed Consent Form is signed
Female subjects of childbearing potential, defined as not surgically sterile or at least two (2) years postmenopausal, must agree to use one of the following forms of contraception from screening through the last study visit: hormonal (oral, implant, or injection) begun >30 days prior to screening; barrier (condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD). Acceptable contraceptive options may also include abstinence, relationship with same sex partner or partner who has had a vasectomy at least six (6) months prior to the screening visit
Male subjects only: willing to use contraception or abstain from sexual activity beginning with the first exposure to study drug and continuing until discharged from the study due to completion or Early Termination
Healthy, as determined by the Investigator (in consultation with the Medical Monitor, as needed), based on medical and dental history, concurrent illnesses, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (extraoral, head and neck) during Screening Note: Subjects on a stable dose of medication may be eligible for screening and will be assessed by the Medical Monitor on a case-by-case basis.
Have a minimum of 12 bicuspids and molars with a minimum of 8 molars and bicuspids NOT having restorations, crowns, sealants

Key exclusion criteria (10 listed)

Advanced periodontal disease
Active caries lesion(s) within 30 days prior to study drug administration (confirmed by comprehensive caries examination including standard radiographs if deemed necessary by the Investigator) Note: Subjects presenting with insipient, non-cavitated lesion(s) are not excluded
Medical condition (e.g., artificial heart valve, history of infective endocarditis, cardiac transplant with valvular dysfunction, congenital heart disease or total joint replacement) for which antibiotics are recommended prior to dental visits and/or procedures
Pathologic lesions of the oral cavity (suspicious or confirmed)
Full dentures or orthodontic appliances, e.g., braces; Note: partial dentures, removable retainers and night guards are not excluded, provided that they are cleaned regularly throughout the duration of the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
C16G2 GelAlso: Antimicrobial peptideAntimicrobial peptide	Drug	Study Arm 1, Study Arm 2, Study Arm 3, Study Arm 4, Study Arm 5, Study Arm 6, Study Arm 7
PlaceboPlacebo	Other	Study Arm 1, Study Arm 2, Study Arm 6, Study Arm 7

Primary outcome

Antimicrobial Activity of C16G2
Time frame: Evaluated over up to 5 months
To assess the targeted antimicrobial activity of C16G2 Gel applications as measured by a reduction in Streptococcus mutans in saliva and dental plaque
Total Oral Bacterial Levels
Time frame: Evaluated 7 days post last study drug administration
Total bacterial levels will be evaluated by measuring cfu/ml counts of salivary and plaque bacteria
Safety of C16G2 Gel Administrations assessed by performing targeted physical examinations, oral cavity exams, taking vital signs and collection of adverse events
Time frame: Up to 7 days post last study drug administration
Safety will be assessed by performing targeted physical examinations, oral cavity exams, taking vital signs and collection of adverse events

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Wolff, DDS, PhD principal investigator

NYU Langone Health

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing C16G2 Gel in people with Dental Caries, run by Armata Pharmaceuticals, Inc. at 10 sites in United States.

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 13 inclusion and 10 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 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Antimicrobial Activity of C16G2 (time frame: Evaluated over up to 5 months). The study lists 3 primary outcomes in all. 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 NCT02594254.

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 1 Aug 2019.