Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02044081 | Phase 2, Safety & Microbiology Study of C16G2 in Multiple Oral Gel &/or Mouth Rinse Doses to Healthy Adults | PHASE2 | COMPLETED | 60 | — | — | Feb 1, 2014 | Aug 1, 2014 | Aug 1, 2019 | 2 | United States |
Safety will be assessed by comparing the incidence and duration of adverse events, clinically significant changes in vital signs, oral cavity assessments and targeted physical exams (C16G2 subjects in the four study arms vs. placebo).
| Arm | Type | Description |
|---|---|---|
| Mouth Rinse Administration | OTHER | Day 0, three consecutive C16G2 or placebo rinse administrations followed by three single C16G2 or placebo rinse administrations. Days 1 to 6 two additional C16G2 or placebo rinse administrations. |
| Dental Tray Gel Administration | OTHER | Day 0, two C16G2 or placebo gel dental tray applications and four C16G2 or placebo rinse administrations. Days 1 to 6, two C16G2 or placebo dental tray applications and two C16G2 or placebo rinse administrations. |
| Electric Toothbrush Gel Application | OTHER | Day 0, four C16G2 or placebo gel administrations applied with an electric toothbrush and four C16G2 or placebo rinse administrations. Days 1 to 6, two C16G2 or placebo gel administrations applied with a electric toothbrush and two C16G2 or placebo rinse administrations. |
| Manual Toothbrush Gel Application | OTHER | Day 0, four C16G2 or Placebo gel administrations applied with a manual toothbrush and four C16G2 or Placebo rinse administrations. Days 1 to 6, two C16G2 or Placebo gel administrations applied with a electric toothbrush and two C16G2 or Placebo rinse administrations. |
| Name | Type | Description |
|---|---|---|
| C16G2 Rinse | DRUG | Active rinses are 1.6 mg/mL C16G2. |
| Placebo | DRUG | Placebo is the vehicle without C16G2 |
| C16G2 Gel | DRUG | Active C16G2 Gel is 3.2 mg/mL |
Inclusion Criteria: Subjects are eligible to participate if they meet the following criteria: * Males and females, 18-75 years of age, inclusive, at the time the Informed Consent Form is signed * Female subjects of childbearing potential, defined as not surgically sterile or at least two (2) years...