Benzocaine Gel Toothache Dose-Response Study - Full Text View

Sponsors and Collaborators:	Consumer Healthcare Products Association CHPA Oral Discomfort Task Group
Information provided by:	Consumer Healthcare Products Association
ClinicalTrials.gov Identifier:	NCT00474175

Purpose

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.

Condition	Intervention	Phase
Toothache	Drug: Placebo gel Drug: benzocaine	Phase IV

Drug Information available for: Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Benzocaine Gel Toothache Dose-Response Study

Further study details as provided by Consumer Healthcare Products Association:

Primary Outcome Measures:

Percentage of responders, where a responder is a subject who experiences an improvement in pain intensity, as exhibited by a pain-score reduction from baseline on the DPS of at least 1 unit [ Time Frame: At any two consecutive time points between 5 and 20 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to onset of pain relief, duration of effect, global satisfaction assessment [ Time Frame: Within 2 hours assessment period ] [ Designated as safety issue: No ]
Label compliance [ Time Frame: After 120 minute test period ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	May 2007
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo control	Drug: Placebo gel single dose (less than 1g) of a matching placebo gel
2: Active Comparator 10% benzocaine gel formulation	Drug: benzocaine single dose (less than 1g) of 10% benzocaine gel formulation
3: Active Comparator 20% benzocaine gel formulation	Drug: benzocaine single dose (less than 1g) of 20% benzocaine gel formulation

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474175

Contacts

Contact: Marcia D Howard, PhD	202-429-9260	mhoward@chpa-info.org
Contact: Alison M Manhoff, JD	202-429-9260	amanhoff@chpa-info.org

Locations

United States, Michigan
University of Detroit Mercy School of Dentistry	Recruiting
Detroit, Michigan, United States, 48219-3580
Principal Investigator: Gary E Jeffers, DMD, MS
United States, New York
State University of New York at Buffalo, School of Dental Medicine	Recruiting
Buffalo, New York, United States, 14214-3008
Principal Investigator: Sebastian G Ciancio, DDS
New York University College of Dentistry	Recruiting
New York, New York, United States, 10010-4086
Principal Investigator: Jonathan A Ship, DMD
United States, Pennsylvania
University of Pennsylvania, School of Dental Medicine	Recruiting
Philadelphia, Pennsylvania, United States, 19104-6003
Principal Investigator: Elliot V Hersh, DMD, MS, PhD

Sponsors and Collaborators

Consumer Healthcare Products Association

CHPA Oral Discomfort Task Group

Investigators

Principal Investigator:	Elliot V Hersh, DMD, MS, PhD	University of Pennsylvania, School of Dental Medicine
Principal Investigator:	Gary E Jeffers, DMD, MS	University of Detroit Mercy School of Dentistry
Principal Investigator:	Sebastian G Ciancio, DDS	State University of New York at Buffalo, School of Dental Medicine
Principal Investigator:	Jonathan A Ship, DMD	New York University School of Medicine
Study Chair:	Heinz Schneider, Dr.Med.	Consumer Healthcare Products Association

More Information

Responsible Party:	Consumer Healthcare Products Association ( Heinz Schneider, Vice President, Regulatory and Scientific Affairs )
Study ID Numbers:	BZ-03-07
Study First Received:	May 14, 2007
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00474175
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Signs and Symptoms
Tooth Diseases
Facies
Facial Pain

Toothache
Benzocaine
Pain
Stomatognathic Diseases

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics

Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 16, 2009