Clinical trial NCT00474175: Benzocaine Gel Toothache Dose-Response Study
Official title: Benzocaine Gel Toothache Dose-Response Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Toothache
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Church & Dwight Company, Inc.
name: Consumer Healthcare Products Association
First posted: 2007-05-16
Enrollment: 577
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With a Response
timeFrame: Baseline, 5, 10, 15 and 20 minutes
Secondary outcomes:
measure: Time to First Confirmed Perceptible Relief
timeFrame: 0 to 120 minutes
measure: Time to Meaningful Relief
timeFrame: 0 to 120 minutes
measure: Duration of Effect
timeFrame: 0 to 120 minutes
measure: Sum of Pain Relief Combined With Pain Intensity Differences (SPRID) Scores
timeFrame: 60 minutes and 120 minutes
measure: Time to Dropping Out Due to Lack of Efficacy or Rescue Medication
timeFrame: 0 to 120 minutes
measure: Pain Relief Combined With Pain Intensity Difference (PRID) Scores
timeFrame: 5 to 120 minutes
measure: Global Satisfaction Assessment
timeFrame: 120 minutes
Other outcomes:
measure: Dosing Compliance Calculated by Evaluating Amount of Study Medication Applied
timeFrame: Baseline and 5 minutes
measure: Dosing Compliance Calculated by Evaluating Percentage of Participants Who Applied no More Than 400 mg of the Study Medication
timeFrame: Baseline and 5 minutes
Locations:
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Buffalo
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: