No Disease State or Condition
Conditions
Keywords
local anesthesia, pain tolerance, experimental pain
Brief summary
The purpose of this study is to determine if the topical application to gingival tissue of the combination of benzocaine and tetracaine has a longer duration of local anesthetic activity than benzocaine alone.
Detailed description
In a blinded study, either benzocaine alone or the combination of benzocaine and tetracaine will be sprayed onto the gingival mucosal tissue. Onset and duration of local anesthesia will be evaluated over a one hour period using pin prick and quantitative sensory testing of heat (QST-heat) stimulation. Subjects will receive both treatments in a cross-over design with each session separated by 4-14 days. A total of 50 subjects (normal volunteers) will be evaluated.
Interventions
COMBINATION_PRODUCTOne spray CTY-5339-A
Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 28 mg) and 2.0% Tetracaine Hydrochloride (USP = 4 mg). Administered in a single anesthetic spray.
DEVICEOne spray CTY-5339-CB
Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredient: 14.0% Benzocaine (USP = 28 mg). Administered in a single anesthetic spray.
DEVICEOne spray CTY-5339-P
Placebo. Metered spray bottle with ≈200 uL total spray volume. Contains no active ingredient (vehicle control).
Sponsors
Cetylite Industries
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female subjects between 18-75 years of age with a Body Mass Index (BMI) ≤32; * Subjects are category I or II on the American Society of Anesthesiologists physical status classification system (ASA category I or II) and are in normal physical health as judged by physical and laboratory examinations; * Subjects have normal appearance of the oral mucosal tissues; * At screening and at Baseline during Stage 1 and Sessions 1 and 2, of Stage 2 subjects with Pin-Prick-Test (PPT) scores of at least 3 (on a 10 point numerical rating scale \[NRS\]) on the 2 readings, 1 of which must be a score of at least 4; * Subjects have mean quantitative sensory test of heat (QST-Heat) pain sensation temperature assessments on the gingival mucosa of 46.5 °C or less based on the average of the 2 readings at screening and at the Baseline Study Sessions for Stages 1 and 2; * Subjects must agree to refrain from ingesting any systemic or topical analgesic medication for 3 days or 5 half-lives of the drug prior to and during the study period and alcohol for 1 day prior to and during the study period; * Subjects must agree to refrain from using mouth rinses, cough drops or throat lozenges on the day of each test session; * Female subjects must be physically incapable of childbearing potential (postmenopausal for more than 1 year or surgically sterile) or practicing an acceptable method of contraception (hormonal, barrier with spermicide, intrauterine device, vasectomized or same sex partner, or abstinence). Subjects using hormonal birth control must have been on a stable dose of treatment for at least 30 days and received at least 1 cycle of treatment prior to randomization. At Screening and at Baseline of both sessions, all females of childbearing potential must have a negative urine pregnancy test and not be breastfeeding; * Negative urine drug screen for drugs of abuse at Screening and at Baseline for each Study Session. A positive drug screen result may be permitted if the subject has been on a stable dose of an allowed medication for \>30 days; * Subjects must be capable of reading, comprehending, and signing the informed consent form.
Exclusion criteria
* Subjects with a history of any significant hepatic, renal, endocrine, cardiac, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders, including glaucoma, diabetes, emphysema, and chronic bronchitis; * Subjects with a history of any type of cancer other than skin related cancers; * Subjects with conditions that affect the absorption, metabolism, or passage of drugs out of the body, (e.g., sprue, celiac disease, Crohn's disease, colitis, or liver, kidney, or thyroid conditions); * Subjects with any history of alcohol or substance abuse (including a positive drug screen test); * Subjects that currently have or have a history of uncontrolled hypertension; * Subjects with a known hypersensitivity to any local anesthetic drug; * Subjects with a hematocrit level significantly below the normal range on the screening laboratory examination (as judged by the PI); * Subjects with any clinically significant abnormal lab result (as judged by the PI); * Subjects with any condition or history felt by the Investigator to place the subject at increased risk; * Subjects who have smoked or chewed tobacco-containing substances within 6 months prior to the start of the study; * Subjects judged by the Investigator to be unable or unwilling to comply with the requirements of the protocol; * Subjects who have used an investigational drug within 30 days prior to entering the study; * Subjects who have donated blood within 3 months prior to the start of the study; * Subjects who have previously participated in the trial; * Subjects who are members of the study site staff directly involved with the study or a relative of the Sponsor or other personnel involved with the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stage II: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB | Up to one hour post-application | The duration of effect, was defined as the length of time in minutes from onset of anesthesia to the absence of anesthesia.Onset was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than Baseline. Absence of anesthesia was defined as follows: After Onset had been established, absence was the first of two time points with consecutive occurrences of regression of absence of analgesia. Reports of less pain by ≥1 unit than Baseline indicated analgesia; while a report of similar (\< 1 unit) or more pain than Baseline indicated regression or absence of analgesia. The minimum onset time was 1 minute. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome. |
| Stage II: Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB | Up to one hour post-application | The duration of effect, was defined as the time from onset to treatment failure, as measured by QST Heat score. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The QST Heat-based Duration of effect was calculated by the length of time in minutes from onset of anesthesia to the absence of anesthesia where Onset of anesthesia was defined by PPT unless specific QST thresholds were not met. After Onset had been established, absence of analgesia or offset was the first of two time points with consecutive occurrences of regression or absence of analgesia. Reports of QST heat pain temperature by ≥ 3 °C of the Baseline QST indicated analgesia; while a report of similar (\<3 °C) than Baseline indicated regression or absence of analgesia. Stage |
| Stage I: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Compared to One Spray CTY-5339-P (Placebo: Vehicle Control) | Up to one hour post-application | The duration of effect, was defined as the length of time in minutes from onset of anesthesia to the absence of anesthesia.Onset was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than Baseline. Absence of anesthesia was defined as follows: After Onset had been established, absence was the first of two time points with consecutive occurrences of regression of absence of analgesia. Reports of less pain by ≥1 unit than Baseline indicated analgesia; while a report of similar (\< 1 unit) or more pain than Baseline indicated regression or absence of analgesia. The minimum onset time was 1 minute. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome. |
| Stage I: Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Compared to One Spray CTY-5339-P (Placebo: Vehicle Control) | Up to one hour post-application | The duration of effect, was defined as the time from onset to treatment failure, as measured by QST Heat score. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The QST Heat-based Duration of effect was calculated by the length of time in minutes from onset of anesthesia to the absence of anesthesia where Onset of anesthesia was defined by PPT unless specific QST thresholds were not met. After Onset had been established, absence of analgesia or offset was the first of two time points with consecutive occurrences of regression or absence of analgesia. Reports of QST heat pain temperature by ≥ 3 °C of the Baseline QST indicated analgesia; while a report of similar (\<3 °C) than Baseline indicated regression or absence of analgesia. Stage I outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stage II: Percentage of Subjects Reaching Minimal Pain on Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale) | Any time within one hour post-application | Response is defined as a subject having a PPT average pain score of ≤2 recorded at any single time point where PPT was performed. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome. |
| Stage II: Duration of Minimal Pain for Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale) | Up to one hour post-application | Response at a time point is defined as having the PPT average pain score of ≤2. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome. |
| Stage II: Percentage of Subjects Reaching Maximum Heat for Heat Sensation Threshold (QST Heat) | Any time within one hour post-application | QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Reaching maximum heat for QST Heat was defined as subjects reaching the maximum temperature without reporting pain at one or more time points. Stage II outcome. |
| Stage II: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc) | Up to one hour post-application | SPID was calculated as a sum of the delta PPT scores at each time point until the designated time point. The delta PPT score is defined as the change in PPT score from baseline. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The total possible scale range was from -100 (best) to +100 (worst) for SPID at the 30 minute time point, and from -160 (best) to +160 (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective). Stage II outcome. |
| Stage II: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc) | Up to one hour post-application | STID was calculated as a sum of the delta QST Heat scores at each time point until the designated time point. The delta QST Heat score is defined as the change in QST Heat score from baseline. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The total possible scale range was from -155 ºC (best) to +155 ºC (worst) for STID at the 30 minute time point, and from -248 ºC (best) to +248 ºC (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective). Stage II outcome. |
| Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Time of application up to one hour post-application | Response at at time point is defined as when the PPT average pain score was less than the Baseline PPT average score by any amount. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome. |
| Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Time of application up to one hour post-application | Response at a time point is defined as an increase of QST heat pain temperature by ≥ 3 degrees C compared to the Baseline QST. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome. |
| Stage II: Onset of Anesthesia for Pin Prick Test (PPT) | Up to one hour post-application | Onset of anesthesia was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than the Baseline PPT. Onset was expected to be between 1 and 5 minutes. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome. |
| Stage I: Percentage of Subjects Reaching Maximum Heat for Heat Sensation Threshold (QST Heat) | Any time within one hour post-application | QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Reaching maximum heat for QST Heat was defined as subjects reaching the maximum temperature without reporting pain at one or more time points. Stage I outcome. |
| Stage I: Onset of Anesthesia for Pin Prick Test (PPT) | Up to one hour post-application | Onset of anesthesia was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than the Baseline PPT. Onset was expected to be between 1 and 5 minutes. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome. |
| Stage I: Onset of Anesthesia for Heat Sensation Threshold (QST Heat) | Up to one hour post-application | Onset of anesthesia was defined by Pin Prick Test (PPT) unless specific QST thresholds were not met. * If the PPT Onset was 5 minutes or less, then QST must have been greater than the Baseline QST temperature at 5 minutes by any amount and QST must have been ≥ 3 °C of the Baseline QST at 5 or 10 minutes. * If the PPT Onset was 10 minutes, then QST must have been ≥ 3 °C of the Baseline QST temperature at 10 minutes. * If PPT did not achieve Onset, then QST alone could have achieved onset at either 5 or 10 minutes if QST was greater than the Baseline QST temperature at 5 or 10 minutes by any amount and the QST was ≥ 3 °C of the Baseline QST at 5 or 10 minutes. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome. |
| Stage I: Percentage of Subjects Reaching Minimal Pain on Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale) | Any time within one hour post-application | Response is defined as a subject having a PPT average pain score of ≤2 recorded at any single time point where PPT was performed. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome. |
| Stage I: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc) | Up to one hour post-application | SPID was calculated as a sum of the delta PPT scores at each time point until the designated time point. The delta PPT score is defined as the change in PPT score from baseline. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The total possible scale range was from -100 (best) to +100 (worst) for SPID at the 30 minute time point, and from -160 (best) to +160 (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective). Stage I outcome. |
| Stage I: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc) | Up to one hour post-application | STID was calculated as a sum of the delta QST Heat scores at each time point until the designated time point. The delta QST Heat score is defined as the change in QST Heat score from baseline. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The total possible scale range was from -155 ºC (best) to +155 ºC (worst) for STID at the 30 minute time point, and from -248 ºC (best) to +248 ºC (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective). Stage I outcome. |
| Stage I: Duration of Minimal Pain for Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale) | Up to one hour post-application | Response at a time point is defined as having the PPT average pain score of ≤2. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome. |
| Stage II: Onset of Anesthesia for Heat Sensation Threshold (QST Heat) | Up to one hour post-application | Onset of anesthesia was defined by Pin Prick Test (PPT) unless specific QST thresholds were not met. * If the PPT Onset was 5 minutes or less, then QST must have been greater than the Baseline QST temperature at 5 minutes by any amount and QST must have been ≥ 3 °C of the Baseline QST at 5 or 10 minutes. * If the PPT Onset was 10 minutes, then QST must have been ≥ 3 °C of the Baseline QST temperature at 10 minutes. * If PPT did not achieve Onset, then QST alone could have achieved onset at either 5 or 10 minutes if QST was greater than the Baseline QST temperature at 5 or 10 minutes by any amount and the QST was ≥ 3 °C of the Baseline QST at 5 or 10 minutes. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome. |
| Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Up to one hour post-application | Response at at time point is defined as when the PPT average pain score was less than the Baseline PPT average score by any amount. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome. |
| Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Up to one hour post-application | Response at a time point is defined as an increase of QST heat pain temperature by ≥ 3 degrees C compared to the Baseline QST. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stage II: One Spray CTY-5339-A, Then One Spray CTY-5339-CB A single spray of CTY-5339-A Anesthetic Spray (14.0% benzocaine and 2.0% tetracaine HCl) tested over a 60 minute session, followed by a 4-14 day washout period, followed by a single spray of CTY-5339-CB Anesthetic Spray (14.0% benzocaine) tested over a 60 minute session. Used in Stage II of the study only. | 24 |
| Stage II: One Spray of CTY-5339-CB, Then One Spray CTY-5339-A A single spray of CTY-5339-CB Anesthetic Spray (14.0% benzocaine) tested over a 60 minute session, followed by a 4-14 day washout period, followed by a single spray of CTY-5339-A Anesthetic Spray (14.0% benzocaine and 2.0% tetracaine HCl) tested over a 60 minute session. Used in Stage II of the study only. | 26 |
| Stage I: One Spray CTY-5339-A Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 28 mg) and 2.0% Tetracaine Hydrochloride (USP = 4 mg). Administered in a single anesthetic spray. Tested over a 60 minute session. Used in Stage I of the study only. | 10 |
| Stage I: One Spray CTY-5339-CB Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredient: 14.0% Benzocaine (USP = 28 mg). Administered in a single anesthetic spray. Tested over a 60 minute session. Used in Stage I of the study only. | 10 |
| Stage I: One Spray CTY-5339-P Metered spray bottle with ≈200 uL total spray volume. Contains no active ingredient (placebo: vehicle control). Administered in a single anesthetic spray. Tested over a 60 minute session. Used in Stage I of the study only. | 5 |
| Total | 75 |
Baseline characteristics
| Characteristic | Stage II: One Spray of CTY-5339-CB, Then One Spray CTY-5339-A | Stage II: One Spray CTY-5339-A, Then One Spray CTY-5339-CB | Total | Stage I: One Spray CTY-5339-P | Stage I: One Spray CTY-5339-CB | Stage I: One Spray CTY-5339-A |
|---|---|---|---|---|---|---|
| Age, Continuous | 23.5 years STANDARD_DEVIATION 1.8 | 24.3 years STANDARD_DEVIATION 4.9 | 25.1 years STANDARD_DEVIATION 3.9 | 26.2 years STANDARD_DEVIATION 2.4 | 27.6 years STANDARD_DEVIATION 2.5 | 28.1 years STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 8 Participants | 2 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 24 Participants | 67 Participants | 3 Participants | 9 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height (inches) | 65.8 inches STANDARD_DEVIATION 2.6 | 67.3 inches STANDARD_DEVIATION 4.1 | 66.4 inches STANDARD_DEVIATION 3.3 | 67.2 inches STANDARD_DEVIATION 2.3 | 65.1 inches STANDARD_DEVIATION 1.9 | 66.9 inches STANDARD_DEVIATION 4.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 8 Participants | 30 Participants | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 5 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 13 Participants | 38 Participants | 3 Participants | 5 Participants | 5 Participants |
| Region of Enrollment United States | 26 participants | 24 participants | 75 participants | 5 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 21 Participants | 15 Participants | 49 Participants | 1 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 26 Participants | 4 Participants | 2 Participants | 6 Participants |
| Weight (lbs) | 141.2 lbs STANDARD_DEVIATION 27.6 | 154.1 lbs STANDARD_DEVIATION 33 | 146.6 lbs STANDARD_DEVIATION 29.9 | 166.0 lbs STANDARD_DEVIATION 35.4 | 128.1 lbs STANDARD_DEVIATION 22.5 | 151.6 lbs STANDARD_DEVIATION 31 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 | 0 / 5 |
| other Total, other adverse events | 2 / 60 | 2 / 60 | 0 / 5 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 | 0 / 5 |
Outcome results
Primary
Stage I: Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Compared to One Spray CTY-5339-P (Placebo: Vehicle Control)
The duration of effect, was defined as the time from onset to treatment failure, as measured by QST Heat score. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The QST Heat-based Duration of effect was calculated by the length of time in minutes from onset of anesthesia to the absence of anesthesia where Onset of anesthesia was defined by PPT unless specific QST thresholds were not met. After Onset had been established, absence of analgesia or offset was the first of two time points with consecutive occurrences of regression or absence of analgesia. Reports of QST heat pain temperature by ≥ 3 °C of the Baseline QST indicated analgesia; while a report of similar (\<3 °C) than Baseline indicated regression or absence of analgesia. Stage I outcome.
Time frame: Up to one hour post-application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| One Spray CTY-5339-A | Stage I: Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Compared to One Spray CTY-5339-P (Placebo: Vehicle Control) | 42.5 minutes | Standard Deviation 21.1 |
| One Spray CTY-5339-CB | Stage I: Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Compared to One Spray CTY-5339-P (Placebo: Vehicle Control) | 6.1 minutes | Standard Deviation 11.49 |
| Stage I: One Spray CTY-5339-P | Stage I: Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Compared to One Spray CTY-5339-P (Placebo: Vehicle Control) | 5 minutes | Standard Deviation 9.3 |
Primary
Stage I: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Compared to One Spray CTY-5339-P (Placebo: Vehicle Control)
The duration of effect, was defined as the length of time in minutes from onset of anesthesia to the absence of anesthesia.Onset was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than Baseline. Absence of anesthesia was defined as follows: After Onset had been established, absence was the first of two time points with consecutive occurrences of regression of absence of analgesia. Reports of less pain by ≥1 unit than Baseline indicated analgesia; while a report of similar (\< 1 unit) or more pain than Baseline indicated regression or absence of analgesia. The minimum onset time was 1 minute. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome.
Time frame: Up to one hour post-application
Population: Placebo duration of effect was not analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| One Spray CTY-5339-A | Stage I: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Compared to One Spray CTY-5339-P (Placebo: Vehicle Control) | 49.2 minutes | Standard Deviation 14.34 |
| One Spray CTY-5339-CB | Stage I: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Compared to One Spray CTY-5339-P (Placebo: Vehicle Control) | 21.3 minutes | Standard Deviation 15.47 |
| Stage I: One Spray CTY-5339-P | Stage I: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Compared to One Spray CTY-5339-P (Placebo: Vehicle Control) | 25.2 minutes | Standard Deviation 30.9 |
Primary
Stage II: Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB
The duration of effect, was defined as the time from onset to treatment failure, as measured by QST Heat score. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The QST Heat-based Duration of effect was calculated by the length of time in minutes from onset of anesthesia to the absence of anesthesia where Onset of anesthesia was defined by PPT unless specific QST thresholds were not met. After Onset had been established, absence of analgesia or offset was the first of two time points with consecutive occurrences of regression or absence of analgesia. Reports of QST heat pain temperature by ≥ 3 °C of the Baseline QST indicated analgesia; while a report of similar (\<3 °C) than Baseline indicated regression or absence of analgesia. Stage
Time frame: Up to one hour post-application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| One Spray CTY-5339-A | Stage II: Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB | 45.5 minutes | Standard Deviation 13.6 |
| One Spray CTY-5339-CB | Stage II: Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB | 40.8 minutes | Standard Deviation 16.3 |
Primary
Stage II: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB
The duration of effect, was defined as the length of time in minutes from onset of anesthesia to the absence of anesthesia.Onset was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than Baseline. Absence of anesthesia was defined as follows: After Onset had been established, absence was the first of two time points with consecutive occurrences of regression of absence of analgesia. Reports of less pain by ≥1 unit than Baseline indicated analgesia; while a report of similar (\< 1 unit) or more pain than Baseline indicated regression or absence of analgesia. The minimum onset time was 1 minute. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome.
Time frame: Up to one hour post-application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| One Spray CTY-5339-A | Stage II: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB | 14.6 minutes | Standard Deviation 16.1 |
| One Spray CTY-5339-CB | Stage II: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB | 7.4 minutes | Standard Deviation 11.1 |
Secondary
Stage I: Duration of Minimal Pain for Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)
Response at a time point is defined as having the PPT average pain score of ≤2. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome.
Time frame: Up to one hour post-application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| One Spray CTY-5339-A | Stage I: Duration of Minimal Pain for Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale) | 14.5 minutes | Standard Deviation 11.7 |
| One Spray CTY-5339-CB | Stage I: Duration of Minimal Pain for Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale) | 2.9 minutes | Standard Deviation 3.3 |
| Stage I: One Spray CTY-5339-P | Stage I: Duration of Minimal Pain for Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale) | 0.2 minutes | Standard Deviation 0.4 |
Secondary
Stage II: Duration of Minimal Pain for Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)
Response at a time point is defined as having the PPT average pain score of ≤2. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome.
Time frame: Up to one hour post-application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| One Spray CTY-5339-A | Stage II: Duration of Minimal Pain for Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale) | 14.6 minutes | Standard Deviation 16.1 |
| One Spray CTY-5339-CB | Stage II: Duration of Minimal Pain for Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale) | 7.4 minutes | Standard Deviation 11.1 |
Secondary
Stage II: Onset of Anesthesia for Heat Sensation Threshold (QST Heat)
Onset of anesthesia was defined by Pin Prick Test (PPT) unless specific QST thresholds were not met. * If the PPT Onset was 5 minutes or less, then QST must have been greater than the Baseline QST temperature at 5 minutes by any amount and QST must have been ≥ 3 °C of the Baseline QST at 5 or 10 minutes. * If the PPT Onset was 10 minutes, then QST must have been ≥ 3 °C of the Baseline QST temperature at 10 minutes. * If PPT did not achieve Onset, then QST alone could have achieved onset at either 5 or 10 minutes if QST was greater than the Baseline QST temperature at 5 or 10 minutes by any amount and the QST was ≥ 3 °C of the Baseline QST at 5 or 10 minutes. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome.
Time frame: Up to one hour post-application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| One Spray CTY-5339-A | Stage II: Onset of Anesthesia for Heat Sensation Threshold (QST Heat) | 1 minutes | Standard Deviation 1.4 |
| One Spray CTY-5339-CB | Stage II: Onset of Anesthesia for Heat Sensation Threshold (QST Heat) | 1.3 minutes | Standard Deviation 2.4 |
Secondary
Stage II: Onset of Anesthesia for Pin Prick Test (PPT)
Onset of anesthesia was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than the Baseline PPT. Onset was expected to be between 1 and 5 minutes. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome.
Time frame: Up to one hour post-application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| One Spray CTY-5339-A | Stage II: Onset of Anesthesia for Pin Prick Test (PPT) | 1.1 minutes | Standard Deviation 0.2 |
| One Spray CTY-5339-CB | Stage II: Onset of Anesthesia for Pin Prick Test (PPT) | 1.1 minutes | Standard Deviation 0.6 |
Secondary
Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Response at a time point is defined as an increase of QST heat pain temperature by ≥ 3 degrees C compared to the Baseline QST. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome.
Time frame: Up to one hour post-application
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 1 minute time point | 36 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 2 minute time point | 37 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 3 minute time point | 37 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 4 minute time point | 37 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 5 minute time point | 37 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 10 minute time point | 38 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 15 minute time point | 38 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 20 minute time point | 36 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 25 minute time point | 32 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 30 minute time point | 28 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 35 minute time point | 24 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 40 minute time point | 22 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 45 minute time point | 19 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 50 minute time point | 17 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 55 minute time point | 14 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 60 minute time point | 13 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 60 minute time point | 9 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 1 minute time point | 29 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 25 minute time point | 24 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 2 minute time point | 30 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 45 minute time point | 12 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 3 minute time point | 30 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 30 minute time point | 19 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 4 minute time point | 30 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 55 minute time point | 11 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 5 minute time point | 31 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 35 minute time point | 15 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 10 minute time point | 34 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 50 minute time point | 12 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 15 minute time point | 31 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 40 minute time point | 15 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 20 minute time point | 29 Participants |
Secondary
Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Response at at time point is defined as when the PPT average pain score was less than the Baseline PPT average score by any amount. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome.
Time frame: Up to one hour post-application
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 3 minute time point | 50 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 1 minute time point | 47 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 2 minute time point | 50 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 4 minute time point | 49 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 5 minute time point | 49 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 10 minute time point | 49 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 15 minute time point | 49 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 20 minute time point | 49 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 25 minute time point | 48 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 30 minute time point | 46 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 35 minute time point | 43 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 40 minute time point | 36 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 45 minute time point | 32 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 50 minute time point | 25 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 55 minute time point | 20 Participants |
| One Spray CTY-5339-A | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 60 minute time point | 19 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 60 minute time point | 18 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 3 minute time point | 48 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 25 minute time point | 45 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 1 minute time point | 46 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 45 minute time point | 21 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 2 minute time point | 48 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 30 minute time point | 42 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 4 minute time point | 48 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 55 minute time point | 20 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 5 minute time point | 49 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 35 minute time point | 34 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 10 minute time point | 49 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 50 minute time point | 20 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 15 minute time point | 48 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 40 minute time point | 27 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 20 minute time point | 46 Participants |
Secondary
Stage II: Percentage of Subjects Reaching Maximum Heat for Heat Sensation Threshold (QST Heat)
QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Reaching maximum heat for QST Heat was defined as subjects reaching the maximum temperature without reporting pain at one or more time points. Stage II outcome.
Time frame: Any time within one hour post-application
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| One Spray CTY-5339-A | Stage II: Percentage of Subjects Reaching Maximum Heat for Heat Sensation Threshold (QST Heat) | 7 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Subjects Reaching Maximum Heat for Heat Sensation Threshold (QST Heat) | 5 Participants |
Secondary
Stage II: Percentage of Subjects Reaching Minimal Pain on Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)
Response is defined as a subject having a PPT average pain score of ≤2 recorded at any single time point where PPT was performed. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome.
Time frame: Any time within one hour post-application
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| One Spray CTY-5339-A | Stage II: Percentage of Subjects Reaching Minimal Pain on Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale) | 50 Participants |
| One Spray CTY-5339-CB | Stage II: Percentage of Subjects Reaching Minimal Pain on Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale) | 50 Participants |
Secondary
Stage II: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc)
SPID was calculated as a sum of the delta PPT scores at each time point until the designated time point. The delta PPT score is defined as the change in PPT score from baseline. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The total possible scale range was from -100 (best) to +100 (worst) for SPID at the 30 minute time point, and from -160 (best) to +160 (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective). Stage II outcome.
Time frame: Up to one hour post-application
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| One Spray CTY-5339-A | Stage II: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc) | SPID at the 30 minute time point | -85.2 score | Standard Deviation 35.9 |
| One Spray CTY-5339-A | Stage II: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc) | SPID at the 60 minute time point | -122.6 score | Standard Deviation 63.52 |
| One Spray CTY-5339-CB | Stage II: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc) | SPID at the 30 minute time point | -63.2 score | Standard Deviation 29.38 |
| One Spray CTY-5339-CB | Stage II: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc) | SPID at the 60 minute time point | -86.6 score | Standard Deviation 53.15 |
Secondary
Stage II: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc)
STID was calculated as a sum of the delta QST Heat scores at each time point until the designated time point. The delta QST Heat score is defined as the change in QST Heat score from baseline. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The total possible scale range was from -155 ºC (best) to +155 ºC (worst) for STID at the 30 minute time point, and from -248 ºC (best) to +248 ºC (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective). Stage II outcome.
Time frame: Up to one hour post-application
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| One Spray CTY-5339-A | Stage II: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc) | STID at the 30 minute time point | 136.5 Degrees Celcius (ºC) | Standard Deviation 67.78 |
| One Spray CTY-5339-A | Stage II: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc) | STID at the 60 minute time point | 214 Degrees Celcius (ºC) | Standard Deviation 140.1 |
| One Spray CTY-5339-CB | Stage II: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc) | STID at the 60 minute time point | 149.1 Degrees Celcius (ºC) | Standard Deviation 142.36 |
| One Spray CTY-5339-CB | Stage II: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc) | STID at the 30 minute time point | 96.6 Degrees Celcius (ºC) | Standard Deviation 72.63 |
Secondary
Stage I: Onset of Anesthesia for Heat Sensation Threshold (QST Heat)
Onset of anesthesia was defined by Pin Prick Test (PPT) unless specific QST thresholds were not met. * If the PPT Onset was 5 minutes or less, then QST must have been greater than the Baseline QST temperature at 5 minutes by any amount and QST must have been ≥ 3 °C of the Baseline QST at 5 or 10 minutes. * If the PPT Onset was 10 minutes, then QST must have been ≥ 3 °C of the Baseline QST temperature at 10 minutes. * If PPT did not achieve Onset, then QST alone could have achieved onset at either 5 or 10 minutes if QST was greater than the Baseline QST temperature at 5 or 10 minutes by any amount and the QST was ≥ 3 °C of the Baseline QST at 5 or 10 minutes. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome.
Time frame: Up to one hour post-application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| One Spray CTY-5339-A | Stage I: Onset of Anesthesia for Heat Sensation Threshold (QST Heat) | 2.0 minutes | Standard Deviation 2.9 |
| One Spray CTY-5339-CB | Stage I: Onset of Anesthesia for Heat Sensation Threshold (QST Heat) | 0.4 minutes | Standard Deviation 0.7 |
| Stage I: One Spray CTY-5339-P | Stage I: Onset of Anesthesia for Heat Sensation Threshold (QST Heat) | 0.8 minutes | Standard Deviation 0.4 |
Secondary
Stage I: Onset of Anesthesia for Pin Prick Test (PPT)
Onset of anesthesia was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than the Baseline PPT. Onset was expected to be between 1 and 5 minutes. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome.
Time frame: Up to one hour post-application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| One Spray CTY-5339-A | Stage I: Onset of Anesthesia for Pin Prick Test (PPT) | 1.3 minutes | Standard Deviation 0.7 |
| One Spray CTY-5339-CB | Stage I: Onset of Anesthesia for Pin Prick Test (PPT) | 1.2 minutes | Standard Deviation 0.4 |
| Stage I: One Spray CTY-5339-P | Stage I: Onset of Anesthesia for Pin Prick Test (PPT) | 2.8 minutes | Standard Deviation 4 |
Secondary
Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Response at a time point is defined as an increase of QST heat pain temperature by ≥ 3 degrees C compared to the Baseline QST. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome.
Time frame: Time of application up to one hour post-application
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 5 minute time point | 8 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 2 minute time point | 7 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 3 minute time point | 8 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 4 minute time point | 8 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 1 minute time point | 7 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 10 minute time point | 9 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 15 minute time point | 9 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 20 minute time point | 9 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 25 minute time point | 9 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 30 minute time point | 8 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 35 minute time point | 6 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 40 minute time point | 6 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 45 minute time point | 6 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 50 minute time point | 6 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 55 minute time point | 6 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 60 minute time point | 6 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 10 minute time point | 3 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 15 minute time point | 2 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 20 minute time point | 2 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 50 minute time point | 0 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 25 minute time point | 1 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 30 minute time point | 1 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 60 minute time point | 0 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 35 minute time point | 1 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 1 minute time point | 2 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 55 minute time point | 0 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 2 minute time point | 3 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 40 minute time point | 0 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 3 minute time point | 3 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 4 minute time point | 3 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 5 minute time point | 3 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 45 minute time point | 0 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 35 minute time point | 0 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 10 minute time point | 4 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 45 minute time point | 0 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 3 minute time point | 4 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 15 minute time point | 4 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 60 minute time point | 0 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 1 minute time point | 4 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 20 minute time point | 4 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 40 minute time point | 0 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 5 minute time point | 4 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 25 minute time point | 1 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 50 minute time point | 0 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 2 minute time point | 4 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 30 minute time point | 0 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 4 minute time point | 4 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Responded to treatment at the 55 minute time point | 0 Participants |
Secondary
Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Response at at time point is defined as when the PPT average pain score was less than the Baseline PPT average score by any amount. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome.
Time frame: Time of application up to one hour post-application
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 1 minute time point | 8 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 2 minute time point | 9 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 3 minute time point | 10 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 4 minute time point | 10 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 5 minute time point | 10 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 10 minute time point | 10 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 15 minute time point | 10 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 20 minute time point | 10 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 25 minute time point | 9 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 30 minute time point | 9 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 35 minute time point | 9 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 40 minute time point | 8 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 45 minute time point | 7 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 50 minute time point | 7 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 55 minute time point | 6 Participants |
| One Spray CTY-5339-A | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 60 minute time point | 6 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 10 minute time point | 10 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 15 minute time point | 8 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 20 minute time point | 4 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 50 minute time point | 1 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 25 minute time point | 4 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 30 minute time point | 2 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 60 minute time point | 1 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 35 minute time point | 2 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 1 minute time point | 8 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 55 minute time point | 1 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 2 minute time point | 10 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 40 minute time point | 1 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 3 minute time point | 10 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 5 minute time point | 10 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 4 minute time point | 10 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 45 minute time point | 1 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 35 minute time point | 2 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 10 minute time point | 3 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 45 minute time point | 2 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 3 minute time point | 3 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 15 minute time point | 3 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 60 minute time point | 2 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 1 minute time point | 4 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 20 minute time point | 2 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 40 minute time point | 2 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 55 minute time point | 2 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 25 minute time point | 2 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 50 minute time point | 2 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 2 minute time point | 3 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 30 minute time point | 2 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 5 minute time point | 2 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Responded to treatment at the 4 minute time point | 3 Participants |
Secondary
Stage I: Percentage of Subjects Reaching Maximum Heat for Heat Sensation Threshold (QST Heat)
QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Reaching maximum heat for QST Heat was defined as subjects reaching the maximum temperature without reporting pain at one or more time points. Stage I outcome.
Time frame: Any time within one hour post-application
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| One Spray CTY-5339-A | Stage I: Percentage of Subjects Reaching Maximum Heat for Heat Sensation Threshold (QST Heat) | 5 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Subjects Reaching Maximum Heat for Heat Sensation Threshold (QST Heat) | 0 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Subjects Reaching Maximum Heat for Heat Sensation Threshold (QST Heat) | 0 Participants |
Secondary
Stage I: Percentage of Subjects Reaching Minimal Pain on Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)
Response is defined as a subject having a PPT average pain score of ≤2 recorded at any single time point where PPT was performed. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome.
Time frame: Any time within one hour post-application
Population: Placebo percentage of response was not analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| One Spray CTY-5339-A | Stage I: Percentage of Subjects Reaching Minimal Pain on Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale) | 10 Participants |
| One Spray CTY-5339-CB | Stage I: Percentage of Subjects Reaching Minimal Pain on Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale) | 9 Participants |
| Stage I: One Spray CTY-5339-P | Stage I: Percentage of Subjects Reaching Minimal Pain on Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale) | 2 Participants |
Secondary
Stage I: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc)
SPID was calculated as a sum of the delta PPT scores at each time point until the designated time point. The delta PPT score is defined as the change in PPT score from baseline. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The total possible scale range was from -100 (best) to +100 (worst) for SPID at the 30 minute time point, and from -160 (best) to +160 (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective). Stage I outcome.
Time frame: Up to one hour post-application
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| One Spray CTY-5339-A | Stage I: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc) | SPID at the 30 minute time point | -82.1 score | Standard Deviation 34.9 |
| One Spray CTY-5339-A | Stage I: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc) | SPID at the 60 minute time point | -128.1 score | Standard Deviation 76.6 |
| One Spray CTY-5339-CB | Stage I: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc) | SPID at the 30 minute time point | -37.8 score | Standard Deviation 42.3 |
| One Spray CTY-5339-CB | Stage I: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc) | SPID at the 60 minute time point | -44.0 score | Standard Deviation 52.7 |
| Stage I: One Spray CTY-5339-P | Stage I: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc) | SPID at the 30 minute time point | -29.3 score | Standard Deviation 36.3 |
| Stage I: One Spray CTY-5339-P | Stage I: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc) | SPID at the 60 minute time point | -53.3 score | Standard Deviation 69.1 |
Secondary
Stage I: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc)
STID was calculated as a sum of the delta QST Heat scores at each time point until the designated time point. The delta QST Heat score is defined as the change in QST Heat score from baseline. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The total possible scale range was from -155 ºC (best) to +155 ºC (worst) for STID at the 30 minute time point, and from -248 ºC (best) to +248 ºC (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective). Stage I outcome.
Time frame: Up to one hour post-application
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| One Spray CTY-5339-A | Stage I: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc) | STID at the 30 minute time point | 153.0 Degrees Celcius (ºC) | Standard Deviation 72 |
| One Spray CTY-5339-A | Stage I: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc) | STID at the 60 minute time point | 320.2 Degrees Celcius (ºC) | Standard Deviation 167.2 |
| One Spray CTY-5339-CB | Stage I: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc) | STID at the 30 minute time point | 10.4 Degrees Celcius (ºC) | Standard Deviation 89.4 |
| One Spray CTY-5339-CB | Stage I: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc) | STID at the 60 minute time point | 26.1 Degrees Celcius (ºC) | Standard Deviation 137 |
| Stage I: One Spray CTY-5339-P | Stage I: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc) | STID at the 30 minute time point | 72.5 Degrees Celcius (ºC) | Standard Deviation 33.6 |
| Stage I: One Spray CTY-5339-P | Stage I: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc) | STID at the 60 minute time point | 134.6 Degrees Celcius (ºC) | Standard Deviation 94.3 |