Benzocaine Gel Toothache Dose-Response Study

Condition(s) targeted: Toothache

Intervention: Placebo gel (Drug); benzocaine (Drug); benzocaine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth

Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com

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.

Official title: Benzocaine Gel Toothache Dose-Response Study

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Percentage of responders, where a responder is a subject who experiences an improvement in pain intensity, as exhibited by a pain-score reduction from baseline on the DPS of at least 1 unit

Secondary outcome:

Time to onset of pain relief, duration of effect, global satisfaction assessment

Label compliance

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 Manager, Email: clintrialparticipation@wyeth.com

Baltimore, Maryland 21201, United States; Recruiting

Detroit, Michigan 48208, United States; Completed

Buffalo, New York 14214-3008, United States; Recruiting

New York, New York 10010-4086, United States; Recruiting

Philadelphia, Pennsylvania 19104-6003, United States; Recruiting

Pittsburgh, Pennsylvania 15261, United States; Recruiting

Starting date: May 2007
Last updated: August 21, 2009