Benzocaine Gel Toothache Dose-Response Study

Wyeth

Status and phase: Completed; Phase 4

Conditions: Toothache

Treatments: Drug: benzocaine; Drug: Placebo gel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00474175

BZ-03-07

Details and patient eligibility

About

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.

Enrollment: 577 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females at least 12 years of age.
• Presence of spontaneous toothache pain in only one permanent tooth. Toothache pain is due only to an open tooth cavity and only as a result of dental caries, loss of a restoration or tooth fracture.
• To qualify for the study, the subject must have a rating of at least moderate pain on the Dental Pain Scale (DPS) and a score of at least 50 mm on the Visual Analog Scale. To be included in the moderate pain stratum, the subjects must have a rating of moderate pain in the DPS and to be included in the severe pain stratum the subjects must have a rating of severe pain in the DPS.
• Females who are neither pregnant, as verified by a urine-based pregnancy test, nor breast-feeding.
• Female subjects of childbearing potential and those who are post-menopausal for less than 2 years must be using a medically approved method of contraception (i.e., oral, transdermal or implanted contraceptive devices, intrauterine device, diaphragm, condom, abstinence, or surgical sterility).
• Subjects must be reliable, cooperative and of adequate intelligence to read and understand the rating scales and other study instructions.
• Subjects must be able to read, comprehend, and sign the consent form. Minors will provide assent to study participation if age appropriate. Parent/legal guardian must be able to read, comprehend, and sign the informed consent form.

Exclusion criteria

• Presence of spontaneous toothache pain in a primary tooth. Presence of spontaneous toothache pain in more than one tooth. Presence of an open tooth cavity in a tooth adjacent to the painful tooth with the open tooth cavity.
• Presence of concomitant oral pain due to any other condition such as: soft-tissue lesions (e.g., aphthous or traumatic ulcer, herpes labialis, acute necrotizing ulcerative gingivitis); or multiple hard-tissue (e.g., carious) lesions; pain due to other surgical procedures, injuries or dental surface sensitivity.
• Presence of a periodontal abscess as diagnosed from an X-ray or clinical examination of the painful tooth.
• Presence of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• History of acute or chronic hemolytic anemia.
• History of sensitivity or allergy to benzocaine or other local anesthetic agents.
• Use of any short-acting oral or topical analgesic/ anesthetic product within 2 hours of enrollment or any long-acting Rx or OTC analgesic product within 4 hours of enrollment.
• Use of an investigational drug or participation in an investigational study within the past 30 days.
• Previous participation in this study.
• Member or a relative of the study site staff or sponsor directly involved in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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577 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo control

Treatment:

Drug: Placebo gel

2

Active Comparator group

Description:

10% benzocaine gel formulation

Treatment:

Drug: benzocaine

Drug: benzocaine

3

Active Comparator group

Description:

20% benzocaine gel formulation

Treatment:

Drug: benzocaine

Drug: benzocaine