Benzocaine Gel Toothache Dose-Response Study

NCT00474175 | Completed Phase 4 Results

• 1 other identifier: BZ-03-07
• Study Type: interventional
• Target: 577
• Locations: 1 country
• Sites: 8

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.

Conditions

Toothache

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Response

  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).

  Baseline, 5, 10, 15 and 20 minutes

Secondary Outcomes (7)

• Time to First Confirmed Perceptible Relief

  0 to 120 minutes

• Time to Meaningful Relief

  0 to 120 minutes

• Duration of Effect

  0 to 120 minutes

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

  60 minutes and 120 minutes

• Time to Dropping Out Due to Lack of Efficacy or Rescue Medication

  0 to 120 minutes

Other Outcomes (2)

• Dosing Compliance Calculated by Evaluating Amount of Study Medication Applied

  Baseline and 5 minutes

• Dosing Compliance Calculated by Evaluating Percentage of Participants Who Applied no More Than 400 mg of the Study Medication

  Baseline and 5 minutes

Study Arms (3)

1

PLACEBO COMPARATOR

Placebo control

Drug: Placebo gel

2

ACTIVE COMPARATOR

10% benzocaine gel formulation

Drug: benzocaine

3

ACTIVE COMPARATOR

20% benzocaine gel formulation

Drug: benzocaine

Interventions

Placebo gel DRUG

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

1

benzocaine DRUG

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

2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead
• Church & Dwight Company, Inc.: collaborator
• Consumer Healthcare Products Association: collaborator

Study Sites (8)

Pfizer Investigational Site

Baltimore, Maryland, 21201, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02111-1527, United States

Location

Pfizer Investigational Site

Detroit, Michigan, 48207, United States

Location

Pfizer Investigational Site

Buffalo, New York, 14214-3008, United States

Location

Pfizer Investigational Site

New York, New York, 10010, United States

Location

Pfizer Investigational Site

Columbus, Ohio, 43205-2696, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19104-6030, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15261-0001, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Toothache

Interventions

Benzocaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2007
• First Posted: May 16, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 28, 2013
• Results First Posted: January 18, 2012

Record last verified: 2013-02

Locations

US (8)