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Benzocaine Gel Toothache Dose-Response Study

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Baltimore, Maryland, 21201 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Toothache
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00474175
Pfizer
Completed
Benzocaine Gel Toothache Dose-Response Study

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Similar Trials

Toothache
NCT00474175
All Genders
12+
Years
Multiple Sites
Benzocaine Gel Toothache Dose-Response Study
Benzocaine Gel Toothache Dose-Response Study
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Toothache
  • Drug: Placebo gel
    single dose (less than 1g) of a matching placebo gel
  • Drug: benzocaine
    single dose (less than 1g) of 10% benzocaine gel formulation
  • Drug: benzocaine
    single dose (less than 1g) of 20% benzocaine gel formulation
  • Placebo Comparator: 1
    Placebo control
    Intervention: Drug: Placebo gel
  • Active Comparator: 2
    10% benzocaine gel formulation
    Intervention: Drug: benzocaine
  • Active Comparator: 3
    20% benzocaine gel formulation
    Intervention: Drug: benzocaine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
577
December 2010
December 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00474175
BZ-03-07
No
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
  • Church & Dwight Company, Inc.
  • Consumer Healthcare Products Association
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
February 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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