- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00474175
Benzocaine Gel Toothache Dose-Response Study
February 22, 2013 updated by: Wyeth is now a wholly owned subsidiary of 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
577
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21201
- Pfizer Investigational Site
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Massachusetts
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Boston, Massachusetts, United States, 02111-1527
- Pfizer Investigational Site
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Michigan
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Detroit, Michigan, United States, 48207
- Pfizer Investigational Site
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New York
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Buffalo, New York, United States, 14214-3008
- Pfizer Investigational Site
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New York, New York, United States, 10010
- Pfizer Investigational Site
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Ohio
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Columbus, Ohio, United States, 43205-2696
- Pfizer Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104-6030
- Pfizer Investigational Site
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Pittsburgh, Pennsylvania, United States, 15261-0001
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
Placebo control
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single dose (less than 1g) of a matching placebo gel
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Active Comparator: 2
10% benzocaine gel formulation
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single dose (less than 1g) of 10% benzocaine gel formulation
single dose (less than 1g) of 20% benzocaine gel formulation
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Active Comparator: 3
20% benzocaine gel formulation
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single dose (less than 1g) of 10% benzocaine gel formulation
single dose (less than 1g) of 20% benzocaine gel formulation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With a Response
Time Frame: Baseline, 5, 10, 15 and 20 minutes
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Responder was defined as participant experiencing improvement in pain intensity, as exhibited by a pain score reduction on the Dental Pain Scale (DPS) from baseline of at least 1 unit for two consecutive assessments anytime between the 5 and 20-minute time points.
Response in DPS scale was assigned values as 0 (None), 1 (Mild), 2 (Moderate) and 3 (Severe).
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Baseline, 5, 10, 15 and 20 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to First Confirmed Perceptible Relief
Time Frame: 0 to 120 minutes
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Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief.
Stopwatch was active up to 120 minutes after dosing or until stopped by the participant, or rescue medication was administered.
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0 to 120 minutes
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Time to Meaningful Relief
Time Frame: 0 to 120 minutes
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Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief.
Stopwatch was active up to 120 minutes after dosing or until stopped by the participant, or rescue medication was administered.
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0 to 120 minutes
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Duration of Effect
Time Frame: 0 to 120 minutes
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Duration of effect was defined as the time difference between onset of effect and its offset.
Onset of effect was the first time point at which two consecutive pain scores less severe than at baseline by at least 1 unit (on the DPS) were attained.
Offset of effect was the first of the following events to occur after onset: time to drop out if the drop out was due to lack of efficacy, time of rescue medication, or the first time point following onset of effect at which two consecutive pain scores that are at least as severe as at baseline were attained.
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0 to 120 minutes
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Sum of Pain Relief Combined With Pain Intensity Differences (SPRID) Scores
Time Frame: 60 minutes and 120 minutes
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SPRID is time-weighted sum of pain relief scores combined with pain intensity difference (PRID) scores over 60 and 120 minutes.
SPRID score range was 0 (worst) to 7 (best) for SPRID 60 and 0 (worst) to 14 (best) for SPRID 120.
PRID is sum of Pain intensity differences (PID) and Dental pain relief scale (DPRS) scores at each post-dosing time point.
PID was calculated as baseline DPS minus DPS score at given time point (DPS range: 0 [none] to 3 [severe]; baseline DPS range from 2-3).
PID score ranges from -1 (worst) to 3 (best).
DPRS is 5-point scale ranging from 0 (No-relief) to 4 (Complete).
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60 minutes and 120 minutes
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Time to Dropping Out Due to Lack of Efficacy or Rescue Medication
Time Frame: 0 to 120 minutes
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Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication (ibuprofen 200-400 mg or acetaminophen 1000 mg), whichever comes first.
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0 to 120 minutes
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Pain Relief Combined With Pain Intensity Difference (PRID) Scores
Time Frame: 5 to 120 minutes
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PRID is sum of PID and DPRS scores at each post-dosing time point.
The overall possible score range, for PRID is -1 (worst) to 7 (best).
PID was calculated as baseline DPS minus DPS score at given time point (DPS range from 0 [none] to 3 [severe]; baseline DPS range from 2-3).
PID score ranges from -1 (worst) to 3 (best).
DPRS is 5-point scale ranging from 0 (No-relief) to 4 (Complete).
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5 to 120 minutes
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Global Satisfaction Assessment
Time Frame: 120 minutes
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Participants were asked to provide an overall assessment of their satisfaction with the study medication on a categorical scale.
Response in this scale was assigned values as 0 (Poor), 1 (Fair), 2 (Good), 3 (Very Good) and 4 (Excellent).
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120 minutes
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dosing Compliance Calculated by Evaluating Amount of Study Medication Applied
Time Frame: Baseline and 5 minutes
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Amount of study medication applied was calculated by weighing medication tube prior and post-dosing.
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Baseline and 5 minutes
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Dosing Compliance Calculated by Evaluating Percentage of Participants Who Applied no More Than 400 mg of the Study Medication
Time Frame: Baseline and 5 minutes
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Baseline and 5 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
May 14, 2007
First Submitted That Met QC Criteria
May 15, 2007
First Posted (Estimate)
May 16, 2007
Study Record Updates
Last Update Posted (Estimate)
February 28, 2013
Last Update Submitted That Met QC Criteria
February 22, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BZ-03-07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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