Conditions: Toothache
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 577
Healthy volunteers: no

Brief summary:
To evaluate the efficacy and safety of benzocaine gel products for the relief of toothache and to assess the subject's compliance with proposed label directions.

Detailed description:

Arms:
arm 1: Placebo control arm 2: 10% benzocaine gel formulation arm 3: 20% benzocaine gel formulation

Interventions: intervention 1: Placebo gel intervention 2: benzocaine intervention 3: benzocaine
Intervention descriptions: intervention 1: single dose (less than 1g) of a matching placebo gel intervention 2: single dose (less than 1g) of 10% benzocaine gel formulation intervention 3: single dose (less than 1g) of 20% benzocaine gel formulation

Protocol document: