Benzocaine Gel Toothache Dose-Response Study

Condition(s) targeted: Toothache

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

Phase: Phase 4

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of Participants With a Response

Secondary outcome:

Time to First Confirmed Perceptible Relief

Time to Meaningful Relief

Duration of Effect

Sum of Pain Relief Combined With Pain Intensity Differences (SPRID) Scores

Time to Dropping Out Due to Lack of Efficacy or Rescue Medication

Pain Relief Combined With Pain Intensity Difference (PRID) Scores

Global Satisfaction Assessment

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.

Pfizer Investigational Site, Baltimore, Maryland 21201, United States

Pfizer Investigational Site, Boston, Massachusetts 02111-1527, United States

Pfizer Investigational Site, Detroit, Michigan 48207, United States

Pfizer Investigational Site, Buffalo, New York 14214-3008, United States

Pfizer Investigational Site, New York, New York 10010, United States

Pfizer Investigational Site, Columbus, Ohio 43205-2696, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania 19104-6030, United States

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15261-0001, United States

To obtain contact information for a study center near you, click here.

Starting date: May 2007
Last updated: February 22, 2013