| Primary | Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8 | Percent change in the average daily pain score from baseline to between Weeks 2 and 8, measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine). | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | Posted | | Mean | Standard Deviation | percentage change | | Baseline to between Weeks 2 to 8 | | | | ID | Title | Description |
|---|
| OG000 | Capsaicin 8% | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 | | OG001 | Placebo | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-27.44± 26.79
- OG001-20.85± 28.92
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| All statistical comparisons were made using two-sided tests at the 5% significance level | ANCOVA | Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates. | 0.025 | | LS Mean Difference | -6.6 | | | 2-Sided | 95 | -12.3 | -0.8 | | | | No | Superiority or Other | | |
|
| Secondary | Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12 | Percent Change in the Average Daily Pain Score from baseline to between Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine). | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | Posted | | Mean | Standard Deviation | percentage change | | Baseline to between Weeks 2 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Capsaicin 8% | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 | | OG001 | Placebo | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 |
| |
| Secondary | Weekly Percent Change From Baseline in Average Daily Pain Score | Weekly Percent Change from baseline in average daily pain score from baseline to Week 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine). | Intention to Treat (ITT ); Baseline last observation carried forward (BLOCF) imputation was used. | Posted | | Mean | Standard Deviation | percentage change | | Baseline to Weeks 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Capsaicin 8% | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 | | OG001 | Placebo | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 |
| |
| Secondary | Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline | Weekly average of average daily pain score at Baseline and Weeks 2,4,8 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine). | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 2, 4, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Capsaicin 8% | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 | | OG001 | Placebo | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 |
| |
| Secondary | Percentage of Participants With 30% Reduction in Average Daily Pain Score. | Percentage of participants achieving 30% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine). | Intention to Treat (ITT ); Baseline last observation carried forward(BLOCF) imputation was used. | Posted | | Number | | percentage of participants | | Baseline, Weeks 2-8 and Weeks 2-12 | | | | ID | Title | Description |
|---|
| OG000 | Capsaicin 8% | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 | | OG001 | Placebo | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 |
| |
| Secondary | Percentage of Participants With 50% Reduction in Average Daily Pain Score. | Percentage of participants achieving 50% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine). | Intention to Treat (ITT ); Baseline last observation carried forward(BLOCF) imputation was used. | Posted | | Number | | percentage of participants | | Baseline, Weeks 2-8 and Weeks 2-12 | | | | ID | Title | Description |
|---|
| OG000 | Capsaicin 8% | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 | | OG001 | Placebo | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 |
| |
| Secondary | Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2 | Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 2 | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | Posted | | Number | | participants | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Capsaicin 8% | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 | | OG001 | Placebo | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 |
| |
| Secondary | Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8 | Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 8 | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | Posted | | Number | | participants | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Capsaicin 8% | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 | | OG001 | Placebo | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 |
| |
| Secondary | Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12 | Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 12 | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | Posted | | Number | | participants | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Capsaicin 8% | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 | | OG001 | Placebo | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 |
| |
| Secondary | Change From Baseline in the European Quality Of Life (QOL) Questionnaire in 5 Dimensions (EQ-5D) With Visual Analog Scale (VAS) to Weeks 2, 8 and 12 | Change from Baseline in the European Quality Of Life (QOL) questionnaire in 5 dimensions (EQ-5D) with Visual Analog Scale (VAS) to Weeks 2, 8 and 12. EQ-5D self-reported questionnaire is used to measure health-related quality of life by measuring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D questionnaire includes a visual analog scale (VAS) which records participants self-rated health status on a graduated (0-100) scale with higher scores indicating higher Health-Related Quality of Life (HRQoL). | Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline to Weeks 2, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Capsaicin 8% | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 | | OG001 | Placebo | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 |
| |
| Secondary | Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Scale From Baseline to Weeks 2, 8 and 12 | The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, that contain 14 items rated on a 4-point Likert-type scale. There are 2 subscales,one assessing depression and the other anxiety. The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance. | Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline to Weeks 2, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Capsaicin 8% | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 | | OG001 | Placebo | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 |
| |
| Secondary | Change in Hospital Anxiety and Depression Scale (HADS) Depression Scale From Baseline to Weeks 2, 8 and 12. | The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, it contains 14 items rated on a 4-point Likert-type scale. There are 2 subscales,one assessing depression and the other anxiety. The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance. | Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline to Weeks 2, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Capsaicin 8% | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 | | OG001 | Placebo | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 |
| |
| Secondary | Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12 | Treatment satisfaction assessment based on Self-Assessment Treatment (SAT II) questionnaire and the question "Over the past 7 days, how much has the study treatment improved your pain level?" | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | Posted | | Number | | participants | | Baseline, Weeks 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Capsaicin 8% | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 | | OG001 | Placebo | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 |
| |
| Secondary | Percent Change in Average Sleep Interference Score From Baseline to Between Weeks 2-8 and Weeks 2-12 | Percent change in average sleep interference was measured by Question 9F of the Brief Pain Inventory-Diabetic Neuropathy (BPI DN) and was used to assess pain and sleep interference index. Daily sleep interference rating scale consists of an 11-point numerical scale with which the patient describes how pain related to diabetes has interfered with their sleep during the past 24 hours. On a scale 0 identifies "pain does not interfere with sleep" and 10 identifies "pain completely interferes with sleep". Average sleep interference score is assessed from baseline to Weeks 2-8 and Weeks 2-12. | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | Posted | | Mean | Standard Deviation | percentage of change | | Baseline, Weeks 2-8 and Weeks 2-12 | | | | ID | Title | Description |
|---|
| OG000 | Capsaicin 8% | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 | | OG001 | Placebo | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 |
| |
| Secondary | Tolerability of Patch Application Assessed by Dermal Assessment on Day 1, 15 Minutes and 60 Minutes After Patch Removal. | Tolerability of patch application was assessed by dermal assessment (0 to 7 point severity score on Dermal Assessment Scale). Data reported is based on the number of participants in the combined category with a score ≥ 4 (Definite edema or higher), 15 and 60 minutes after patch removal. | Safety Analysis Set (SAF) | Posted | | Number | | participants | | Day 1, 15 minutes and 60 minutes after patch removal | | | | ID | Title | Description |
|---|
| OG000 | Capsaicin 8% | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 | | OG001 | Placebo | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 |
| |
| Secondary | Change From Pre-application in"Pain Now" Score | Change from pre-application in"Pain Now" score was measured on a scale from 0-10 where 0 equates to "No Pain" and 10 to "Pain as bad as you can imagine". Participants were asked to provide pain ratings relative only to the area of pain undergoing treatment. | Safety Analysis Set (SAF) | Posted | | Mean | Standard Deviation | units on a scale | | Pre-application and 15 minutes and 60 minutes after patch removal | | | | ID | Title | Description |
|---|
| OG000 | Capsaicin 8% | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 | | OG001 | Placebo | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 |
| |
| Secondary | Number of Participants Who Used Rescue Pain Medication Days 1 Through 5 | Summarized number of participants who used Rescue Pain Medications for Pain | Safety Analysis Set (SAF) | Posted | | Number | | participants | | Days 1 - 5 | | | | ID | Title | Description |
|---|
| OG000 | Capsaicin 8% | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 | | OG001 | Placebo | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 |
| |
| Secondary | Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12 | Number of patients assessed for Safety through Adverse Events (AE) and Serious Adverse Events (SAE), vital signs, and laboratory analyses from baseline to week 12 | Safety Analysis Set (SAF) | Posted | | Number | | participants | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Capsaicin 8% | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 | | OG001 | Placebo | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 |
| |