Trial · NCT03233737
Pain Study to Assess Local Anesthetic Efficacy and Safety of CTY-5339 on Gingival Mucosal Tissue in Normal Volunteers
NCT03233737, Phase 2, Completed, Cetylite Industries; results first posted 2019-08-21
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Pain Study to Assess Local Anesthetic Efficacy and Safety of CTY-5339 on Gingival Mucosal Tissue in Normal Volunteers. Trials, record NCT03233737. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03233737
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pain Study to Assess Local Anesthetic Efficacy and Safety of CTY-5339 on Gingival Mucosal Tissue in Normal Volunteers
- NCT number
- NCT03233737
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 75 participants, actual
- Lead sponsor
- Cetylite Industries
- Conditions
- No Disease State or Condition
- Interventions
- One spray CTY-5339-A, One spray CTY-5339-CB, One spray CTY-5339-P
- First posted
- 2017-07-31
- Last updated
- 2019-08-21
- Results first posted
- 2019-08-21
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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. |
| 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 | 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 |
| 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) | 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. |
| 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) | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Up to one hour post-application | minutes | MEAN | |
| 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 | Up to one hour post-application | minutes | MEAN | |
| 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) | Up to one hour post-application | Placebo duration of effect was not analyzed. | minutes | MEAN |
| 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) | Up to one hour post-application | minutes | MEAN | |
| SECONDARY | Stage II: Onset of Anesthesia for Pin Prick Test (PPT) | Up to one hour post-application | minutes | MEAN | |
| SECONDARY | Stage II: Onset of Anesthesia for Heat Sensation Threshold (QST Heat) | Up to one hour post-application | minutes | MEAN | |
| SECONDARY | Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point | Up to one hour post-application | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point | Up to one hour post-application | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Stage II: Duration of Minimal Pain for Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale) | Up to one hour post-application | minutes | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group215
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | One Spray CTY-5339-A | 14.6 | Standard Deviation 16.1 | minutes | |
| 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 | One Spray CTY-5339-CB | 7.4 | Standard Deviation 11.1 | minutes | |
| 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 | One Spray CTY-5339-A | 45.5 | Standard Deviation 13.6 | minutes | |
| 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 | One Spray CTY-5339-CB | 40.8 | Standard Deviation 16.3 | minutes | |
| 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) | Stage I: One Spray CTY-5339-A | 49.2 | Standard Deviation 14.34 | minutes | |
| 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) | Stage I: One Spray CTY-5339-CB | 21.3 | Standard Deviation 15.47 | minutes | |
| 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) | Stage I: One Spray CTY-5339-P | 25.2 | Standard Deviation 30.9 | minutes | |
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) | Stage I: One Spray CTY-5339-A | 42.5 | Standard Deviation 21.10 | minutes | |
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) | Stage I: One Spray CTY-5339-CB | 6.1 | Standard Deviation 11.49 | minutes | |
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) | Stage I: One Spray CTY-5339-P | 5 | Standard Deviation 9.3 | minutes |
1 to 10 of 215Source ClinicalTrials.gov
See all 215 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stage I: One Spray CTY-5339-A | 10 | |
| Overall Study | STARTED | Stage I: One Spray CTY-5339-CB | 10 | |
| Overall Study | STARTED | Stage I: One Spray CTY-5339-P | 5 | |
| Overall Study | STARTED | Stage II: One Spray CTY-5339-A, Then One Spray CTY-5339-CB | 24 | |
| Overall Study | STARTED | Stage II: One Spray of CTY-5339-CB, Then One Spray CTY-5339-A | 26 | |
| Overall Study | COMPLETED | Stage I: One Spray CTY-5339-A | 10 | |
| Overall Study | COMPLETED | Stage I: One Spray CTY-5339-CB | 10 | |
| Overall Study | COMPLETED | Stage I: One Spray CTY-5339-P | 5 | |
| Overall Study | COMPLETED | Stage II: One Spray CTY-5339-A, Then One Spray CTY-5339-CB | 24 | |
| Overall Study | COMPLETED | Stage II: One Spray of CTY-5339-CB, Then One Spray CTY-5339-A | 26 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | One Spray CTY-5339-A | 1 | 60 | 1 |
| other | Headache | Nervous system disorders | One Spray CTY-5339-CB | 0 | 60 | 0 |
| other | Headache | Nervous system disorders | One Spray CTY-5339-P | 0 | 5 | 0 |
| other | Nasal Congestion | Respiratory, thoracic and mediastinal disorders | One Spray CTY-5339-A | 1 | 60 | 1 |
| other | Nasal Congestion | Respiratory, thoracic and mediastinal disorders | One Spray CTY-5339-CB | 0 | 60 | 0 |
| other | Nasal Congestion | Respiratory, thoracic and mediastinal disorders | One Spray CTY-5339-P | 0 | 5 | 0 |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | One Spray CTY-5339-A | 1 | 60 | 1 |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | One Spray CTY-5339-CB | 0 | 60 | 0 |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | One Spray CTY-5339-P | 0 | 5 | 0 |
| other | Pharyngitis streptococcal | Respiratory, thoracic and mediastinal disorders | One Spray CTY-5339-A | 0 | 60 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | One Spray CTY-5339-A | 0 | 60 |
| Total, all-cause mortality | One Spray CTY-5339-CB | 0 | 60 |
| Total, all-cause mortality | One Spray CTY-5339-P | 0 | 5 |
| Total, other adverse events | One Spray CTY-5339-A | 2 | 60 |
| Total, other adverse events | One Spray CTY-5339-CB | 2 | 60 |
| Total, other adverse events | One Spray CTY-5339-P | 0 | 5 |
| Total, serious adverse events | One Spray CTY-5339-A | 0 | 60 |
| Total, serious adverse events | One Spray CTY-5339-CB | 0 | 60 |
| Total, serious adverse events | One Spray CTY-5339-P | 0 | 5 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30660443 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| One Spray CTY-5339-A vs One Spray CTY-5339-CB: Stage II: Percentage of Subjects Reaching Maximum Heat for Heat Sensation Threshold (QST Heat) | Trial comparisons |
| One Spray CTY-5339-A vs 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) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03233737
GET https://conductscience.org/api/trials/v1/NCT03233737/registered?page=2