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Completed

NCT Number: NCT00474175

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.

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Key information

Conditions

Toothache Facial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo Gel

Drug

single dose (less than 1g) of a matching placebo gel

Benzocaine

Drug

single dose (less than 1g) of 10% benzocaine gel formulation

Primary outcomes

  1. Percentage of Participants With a Response

    Time frame: Baseline, 5, 10, 15 and 20 minutes

    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).

Secondary outcomes

  1. Time to First Confirmed Perceptible Relief

    Time frame: 0 to 120 minutes

    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.

  2. Time to Meaningful Relief

    Time frame: 0 to 120 minutes

    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.

  3. Duration of Effect

    Time frame: 0 to 120 minutes

    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.

  4. Sum of Pain Relief Combined With Pain Intensity Differences (SPRID) Scores

    Time frame: 60 minutes and 120 minutes

    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).

  5. Time to Dropping Out Due to Lack of Efficacy or Rescue Medication

    Time frame: 0 to 120 minutes

    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.

  6. Pain Relief Combined With Pain Intensity Difference (PRID) Scores

    Time frame: 5 to 120 minutes

    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).

  7. Global Satisfaction Assessment

    Time frame: 120 minutes

    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).

Other outcomes

  1. Dosing Compliance Calculated by Evaluating Amount of Study Medication Applied

    Time frame: Baseline and 5 minutes

    Amount of study medication applied was calculated by weighing medication tube prior and post-dosing.

  2. 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

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Collaborators

  • Church & Dwight Company, Inc.
  • Consumer Healthcare Products Association

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
May 16, 2007
Registry last updated
Feb 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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