Benzocaine Gel Toothache Dose-Response Study
Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Toothache
Intervention: Placebo gel (Drug); benzocaine (Drug); benzocaine (Drug)
Phase: Phase 4
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
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.
- 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
- 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.
- 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
- 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
Locations and Contacts
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