ToothachePhase 4NCT00474175
Benzocaine Gel Toothache Dose-Response Study
A Phase 4 study testing benzocaine in people with Toothache, run by Wyeth is now a wholly owned subsidiary of Pfizer at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Toothache
- What is being tested?
- benzocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 577 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2007to Dec 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Pfizer Investigational Site
Baltimore, Maryland, 21201
Pfizer Investigational Site
Boston, Massachusetts, 02111-1527
Pfizer Investigational Site
Buffalo, New York, 14214-3008
Pfizer Investigational Site
Columbus, Ohio, 43205-2696
Pfizer Investigational Site
Detroit, Michigan, 48207
Pfizer Investigational Site
New York, New York, 10010
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104-6030
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15261-0001
About this 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.
- Conditions
- Toothache
- Being tested
- Placebo gel, benzocaine
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo gelDrug
single dose (less than 1g) of a matching placebo gel
benzocaineDrug
single dose (less than 1g) of 10% benzocaine gel formulation
benzocaineDrug
single dose (less than 1g) of 20% benzocaine gel formulation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo control Receives: Drug: Placebo gel |
| 2 | Active comparator | 10% benzocaine gel formulation Receives: Drug: benzocaine |
| 3 | Active comparator | 20% benzocaine gel formulation Receives: Drug: benzocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 5, 10, 15 and 20 minutes
Secondary outcomes (7)
Time to First Confirmed Perceptible Relief
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.
Measured: 0 to 120 minutes
Time to Meaningful Relief
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.
Measured: 0 to 120 minutes
Duration of Effect
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.
Measured: 0 to 120 minutes
Sum of Pain Relief Combined With Pain Intensity Differences (SPRID) Scores
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).
Measured: 60 minutes and 120 minutes
Time to Dropping Out Due to Lack of Efficacy or Rescue Medication
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.
Measured: 0 to 120 minutes
Pain Relief Combined With Pain Intensity Difference (PRID) Scores
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).
Measured: 5 to 120 minutes
Global Satisfaction Assessment
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).
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ToothacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 577 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Church & Dwight Company, Inc., Consumer Healthcare Products Association
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474175
- Sponsor's protocol ID
- BZ-03-07
- Status last verified
- Feb 2013
- First submitted
- 14 May 2007
- Last updated
- 28 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benzocaine Gel Toothache Dose-Response Study
- ClinicalTrials.gov ID
- NCT00474175
- Acronym / sponsor ID
- BZ-03-07
- Conditions
- Toothache
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Church & Dwight Company, Inc., Consumer Healthcare Products Association
- Study start
- May 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 May 2007 (estimated)
- Results
- Posted 18 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo gelPlacebo control |
| 2 | Active comparator | Drug: benzocaine10% benzocaine gel formulation |
| 3 | Active comparator | Drug: benzocaine20% benzocaine gel formulation |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo gelsingle dose (less than 1g) of a matching placebo gel | Drug | 1 |
| benzocainesingle dose (less than 1g) of 10% benzocaine gel formulation | Drug | 2 |
| benzocainesingle dose (less than 1g) of 20% benzocaine gel formulation | Drug | 3 |
Primary outcome
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).
7 secondary outcomes
Time to First Confirmed Perceptible Relief
Time frame: 0 to 120 minutes
Time to Meaningful Relief
Time frame: 0 to 120 minutes
Duration of Effect
Time frame: 0 to 120 minutes
Sum of Pain Relief Combined With Pain Intensity Differences (SPRID) Scores
Time frame: 60 minutes and 120 minutes
Time to Dropping Out Due to Lack of Efficacy or Rescue Medication
Time frame: 0 to 120 minutes
Pain Relief Combined With Pain Intensity Difference (PRID) Scores
Time frame: 5 to 120 minutes
Global Satisfaction Assessment
Time frame: 120 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Toothache
RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
RecruitingObservational study
Compare the Intensity of Pain Felt by Children During the Local Anesthesia Procedure to That Perceived by the Accompanying Parent.
Dental Pain, Dental Anxiety
RecruitingObservational study
Exploration of the Utility of Dental-dedicated MRI for Dentistry
Dental Crowding, Dental Occlusion, Traumatic
Active, not recruiting
Laser Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis
Irreversible Pulpitis (Toothache)
Active, not recruiting
Er:YAG Laser Versus Conventional Cavity Preparation in Children With Molar-Incisor Hypomineralization
Molar-Incisor Hypomineralization (MIH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing benzocaine in people with Toothache, run by Wyeth is now a wholly owned subsidiary of Pfizer at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With a Response (time frame: Baseline, 5, 10, 15 and 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2013.