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| Name | Class |
|---|---|
| Church & Dwight Company, Inc. | INDUSTRY |
| Consumer Healthcare Products Association | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo control |
|
| 2 | Active Comparator | 10% benzocaine gel formulation |
|
| 3 | Active Comparator | 20% benzocaine gel formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo gel | Drug | single dose (less than 1g) of a matching placebo gel |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 to 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Dosing Compliance Calculated by Evaluating Amount of Study Medication Applied | Amount of study medication applied was calculated by weighing medication tube prior and post-dosing. | Baseline and 5 minutes |
| Dosing Compliance Calculated by Evaluating Percentage of Participants Who Applied no More Than 400 mg of the Study Medication |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Baltimore | Maryland | 21201 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions. |
| FG001 | Benzocaine 10% | Single dose of 10% benzocaine gel administered as per product label directions. |
| FG002 | Benzocaine 20% | Single dose of 20% benzocaine gel administered as per product label directions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions. |
| BG001 | Benzocaine 10% | Single dose of 10% benzocaine gel administered as per product label directions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Demographic data is only available for 576 participants who received study medication, except 1 participant who was randomized but not treated. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Intent to treat (ITT) population included all randomized participants who received study medication. | Posted | Number | Percentage of participants | Baseline, 5, 10, 15 and 20 minutes |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diplopia | Eye disorders | MedDRA 6.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D014098 | Toothache |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D001566 | Benzocaine |
| ID | Term |
|---|---|
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| benzocaine |
| Drug |
single dose (less than 1g) of 10% benzocaine gel formulation |
|
| benzocaine | Drug | single dose (less than 1g) of 20% benzocaine gel formulation |
|
| 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. | 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. | 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). | 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. | 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). | 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). | 120 minutes |
| Baseline and 5 minutes |
| Boston |
| Massachusetts |
| 02111-1527 |
| United States |
| Pfizer Investigational Site | Detroit | Michigan | 48207 | United States |
| Pfizer Investigational Site | Buffalo | New York | 14214-3008 | United States |
| Pfizer Investigational Site | New York | New York | 10010 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43205-2696 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19104-6030 | United States |
| Pfizer Investigational Site | Pittsburgh | Pennsylvania | 15261-0001 | United States |
| Ineligible |
|
| Protocol Violation |
|
| Administrative |
|
| BG002 | Benzocaine 20% | Single dose of 20% benzocaine gel administered as per product label directions. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Demographic data is only available for 576 participants who received study medication, except 1 participant who was randomized but not treated. | Count of Participants | Participants |
|
Single dose of 10% benzocaine gel administered as per product label directions. |
| OG002 | Benzocaine 20% | Single dose of 20% benzocaine gel administered as per product label directions. |
|
|
|
| Secondary | 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. | ITT population included all randomized participants who received study medication. | Posted | Median | 95% Confidence Interval | Minutes | 0 to 120 minutes |
|
|
|
|
| Secondary | 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. | ITT population included all randomized participants who received study medication. | Posted | Median | 95% Confidence Interval | Minutes | 0 to 120 minutes |
|
|
|
|
| Secondary | 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. | ITT population included all randomized participants who received study medication. | Posted | Median | 95% Confidence Interval | Minutes | 0 to 120 minutes |
|
|
|
| Secondary | 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). | ITT population included all randomized participants who received study medication. | Posted | Mean | Standard Deviation | Units on a scale | 60 minutes and 120 minutes |
|
|
|
|
| Secondary | 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. | ITT population included all randomized participants who received study medication. | Posted | Median | 95% Confidence Interval | Minutes | 0 to 120 minutes |
|
|
|
| Secondary | 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). | ITT population included all randomized participants who received study medication. | Posted | Mean | Standard Deviation | Units on a scale | 5 to 120 minutes |
|
|
|
|
| Secondary | 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). | ITT population included all randomized participants who received study medication. | Posted | Mean | Standard Deviation | Units on a scale | 120 minutes |
|
|
|
|
| Other Pre-specified | Dosing Compliance Calculated by Evaluating Amount of Study Medication Applied | Amount of study medication applied was calculated by weighing medication tube prior and post-dosing. | Safety population included all participants who received at least 1 dose of study medication and had follow up data. | Posted | Mean | Standard Deviation | Milligram (mg) | Baseline and 5 minutes |
|
|
|
| Other Pre-specified | Dosing Compliance Calculated by Evaluating Percentage of Participants Who Applied no More Than 400 mg of the Study Medication | Safety population included all participants who received at least 1 dose of study medication and had follow up data. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and 5 minutes |
|
|
|
| 0 |
| 115 |
| 4 |
| 115 |
| EG001 | Benzocaine 10% | Single dose of 10% benzocaine gel administered as per product label directions. | 0 | 233 | 6 | 233 |
| EG002 | Benzocaine 20% | Single dose of 20% benzocaine gel administered as per product label directions. | 0 | 228 | 6 | 228 |
| Eructation | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Stomach upset | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Post operation wound infection | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
|
| Tooth caries Not Otherwise Specified (NOS) | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 6.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 6.0 | Non-systematic Assessment |
|
Wyeth has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 10% relative to the Placebo was calculated. C.I. was based on the Wald statistic. | Regression, Cox | <0.001 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Hazard Ratio (HR) | 1.63 | 2-Sided | 95 | 1.26 | 2.12 | No | Superiority or Other |
| P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Benzocaine 10% was calculated. C.I. was based on the Wald statistic. | Regression, Cox | 0.030 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Hazard Ratio (HR) | 1.24 | 2-Sided | 95 | 1.02 | 1.51 | No | Superiority or Other |
| P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 10% relative to the Placebo was calculated. C.I. was based on the Wald statistic. | Regression, Cox | <0.001 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Hazard Ratio (HR) | 1.73 | 2-Sided | 95 | 1.34 | 2.25 | No | Superiority or Other |
| P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Benzocaine 10% was calculated. C.I. was based on the Wald statistic. | Regression, Cox | 0.100 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Hazard Ratio (HR) | 1.18 | 2-Sided | 95 | 0.97 | 1.43 | No | Superiority or Other |
|
| SPRID 60: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.173 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.32 | 2-Sided | 95 | -0.14 | 0.78 | No | Superiority or Other |
| SPRID 60: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.358 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.18 | 2-Sided | 95 | -0.20 | 0.55 | No | Superiority or Other |
| SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.135 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.75 | 2-Sided | 95 | -0.23 | 1.72 | No | Superiority or Other |
| SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.332 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.48 | 2-Sided | 95 | -0.49 | 1.46 | No | Superiority or Other |
| SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.517 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.26 | 2-Sided | 95 | -0.53 | 1.06 | No | Superiority or Other |
|
| 15 minutes |
|
| 20 minutes |
|
| 25 minutes |
|
| 30 minutes |
|
| 40 minutes |
|
| 50 minutes |
|
| 60 minutes |
|
| 70 minutes |
|
| 80 minutes |
|
| 90 minutes |
|
| 100 minutes |
|
| 110 minutes |
|
| 120 minutes |
|
| 5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.011 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.55 | 2-Sided | 95 | 0.13 | 0.97 | No | Superiority or Other |
| 5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.031 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.38 | 2-Sided | 95 | 0.03 | 0.72 | No | Superiority or Other |
| 10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | <0.001 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.78 | 2-Sided | 95 | 0.33 | 1.23 | No | Superiority or Other |
| 10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.031 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.49 | 2-Sided | 95 | 0.04 | 0.94 | No | Superiority or Other |
| 10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.119 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.29 | 2-Sided | 95 | -0.07 | 0.66 | No | Superiority or Other |
| 15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.002 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.77 | 2-Sided | 95 | 0.28 | 1.25 | No | Superiority or Other |
| 15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.061 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.46 | 2-Sided | 95 | -0.02 | 0.95 | No | Superiority or Other |
| 15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.131 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.30 | 2-Sided | 95 | -0.09 | 0.70 | No | Superiority or Other |
| 20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.044 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.52 | 2-Sided | 95 | 0.01 | 1.03 | No | Superiority or Other |
| 20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.099 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.43 | 2-Sided | 95 | -0.08 | 0.93 | No | Superiority or Other |
| 20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.647 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.10 | 2-Sided | 95 | -0.32 | 0.51 | No | Superiority or Other |
| 25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.023 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.60 | 2-Sided | 95 | 0.08 | 1.11 | No | Superiority or Other |
| 25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.072 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.47 | 2-Sided | 95 | -0.04 | 0.98 | No | Superiority or Other |
| 25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.551 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.13 | 2-Sided | 95 | -0.29 | 0.55 | No | Superiority or Other |
| 30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.047 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.54 | 2-Sided | 95 | 0.01 | 1.08 | No | Superiority or Other |
| 30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.316 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.27 | 2-Sided | 95 | -0.26 | 0.81 | No | Superiority or Other |
| 30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.224 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.27 | 2-Sided | 95 | -0.17 | 0.71 | No | Superiority or Other |
| 40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.099 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.46 | 2-Sided | 95 | -0.09 | 1.01 | No | Superiority or Other |
| 40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.186 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.37 | 2-Sided | 95 | -0.18 | 0.92 | No | Superiority or Other |
| 40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.684 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.09 | 2-Sided | 95 | -0.35 | 0.54 | No | Superiority or Other |
| 50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.452 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.21 | 2-Sided | 95 | -0.34 | 0.76 | No | Superiority or Other |
| 50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.479 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.20 | 2-Sided | 95 | -0.35 | 0.75 | No | Superiority or Other |
| 50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.955 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.01 | 2-Sided | 95 | -0.44 | 0.46 | No | Superiority or Other |
| 60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.465 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.21 | 2-Sided | 95 | -0.36 | 0.79 | No | Superiority or Other |
| 60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.992 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.00 | 2-Sided | 95 | -0.57 | 0.58 | No | Superiority or Other |
| 60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.376 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.21 | 2-Sided | 95 | -0.26 | 0.68 | No | Superiority or Other |
| 70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.229 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.36 | 2-Sided | 95 | -0.22 | 0.93 | No | Superiority or Other |
| 70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.581 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.16 | 2-Sided | 95 | -0.41 | 0.74 | No | Superiority or Other |
| 70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.422 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.19 | 2-Sided | 95 | -0.28 | 0.66 | No | Superiority or Other |
| 80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.271 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.33 | 2-Sided | 95 | -0.26 | 0.91 | No | Superiority or Other |
| 80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.612 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.15 | 2-Sided | 95 | -0.43 | 0.73 | No | Superiority or Other |
| 80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.465 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.18 | 2-Sided | 95 | -0.30 | 0.65 | No | Superiority or Other |
| 90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.290 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.32 | 2-Sided | 95 | -0.27 | 0.91 | No | Superiority or Other |
| 90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.412 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.25 | 2-Sided | 95 | -0.34 | 0.83 | No | Superiority or Other |
| 90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.769 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.07 | 2-Sided | 95 | -0.41 | 0.55 | No | Superiority or Other |
| 100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.610 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.15 | 2-Sided | 95 | -0.43 | 0.74 | No | Superiority or Other |
| 100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.511 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.20 | 2-Sided | 95 | -0.39 | 0.78 | No | Superiority or Other |
| 100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.859 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | -0.04 | 2-Sided | 95 | -0.52 | 0.43 | No | Superiority or Other |
| 110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.386 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.26 | 2-Sided | 95 | -0.33 | 0.84 | No | Superiority or Other |
| 110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.563 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.17 | 2-Sided | 95 | -0.41 | 0.76 | No | Superiority or Other |
| 110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.721 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.09 | 2-Sided | 95 | -0.39 | 0.56 | No | Superiority or Other |
| 120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.725 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.10 | 2-Sided | 95 | -0.48 | 0.69 | No | Superiority or Other |
| 120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.839 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.06 | 2-Sided | 95 | -0.52 | 0.64 | No | Superiority or Other |
| 120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects. | ANOVA | 0.855 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.04 | 2-Sided | 95 | -0.43 | 0.52 | No | Superiority or Other |
| P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 10% versus Placebo) and the associated confidence interval were calculated based on the weighted Gamma statistic. | Cochran-Mantel-Haenszel | 0.039 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | 0.16 | 2-Sided | 95 | -0.00 | 0.33 | No | Superiority or Other |
| P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 20% versus Benzocaine 10%) and the associated confidence interval were calculated based on the weighted Gamma statistic. | Cochran-Mantel-Haenszel | 0.944 | The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons. | Treatment difference | -0.01 | 2-Sided | 95 | -0.15 | 0.13 | No | Superiority or Other |