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Benzocaine Gel Toothache Dose-Response Study

Information source: Wyeth
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

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

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.

Clinical Details

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

Eligibility

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.

Locations and Contacts

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

Additional Information

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

Page last updated: October 19, 2009

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