Trial · NCT01533428
A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN)
NCT01533428, Phase 3, Completed, Astellas Pharma Inc; results first posted 2015-03-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN). Trials, record NCT01533428. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01533428
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN)
- NCT number
- NCT01533428
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 369 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Diabetic Peripheral Neuropathy, Pain
- Interventions
- Capsaicin 8%, Placebo
- First posted
- 2012-02-15
- Last updated
- 2015-11-04
- Results first posted
- 2015-03-13
- Limitations and caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8 | Baseline to between Weeks 2 to 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). |
| Secondary | Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12 | 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). |
| Secondary | Weekly Percent Change From Baseline in Average Daily Pain Score | Baseline to Weeks 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12 | 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). |
| Secondary | Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline | Baseline and Weeks 2, 4, 8 and 12 | 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). |
| Secondary | Percentage of Participants With 30% Reduction in Average Daily Pain Score. | Baseline, Weeks 2-8 and Weeks 2-12 | 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). |
| Secondary | Percentage of Participants With 50% Reduction in Average Daily Pain Score. | Baseline, Weeks 2-8 and Weeks 2-12 | 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). |
| Secondary | Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2 | Baseline to 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 |
| Secondary | Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8 | Baseline to 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 |
| Secondary | Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12 | Baseline to 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 |
| 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 | Baseline 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). |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8 | Baseline to between Weeks 2 to 8 | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | percentage change | MEAN |
| SECONDARY | Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12 | Baseline to between Weeks 2 and 12 | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | percentage change | MEAN |
| SECONDARY | Weekly Percent Change From Baseline in Average Daily Pain Score | Baseline to Weeks 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12 | Intention to Treat (ITT ); Baseline last observation carried forward (BLOCF) imputation was used. | percentage change | MEAN |
| SECONDARY | Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline | Baseline and Weeks 2, 4, 8 and 12 | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With 30% Reduction in Average Daily Pain Score. | Baseline, Weeks 2-8 and Weeks 2-12 | Intention to Treat (ITT ); Baseline last observation carried forward(BLOCF) imputation was used. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With 50% Reduction in Average Daily Pain Score. | Baseline, Weeks 2-8 and Weeks 2-12 | Intention to Treat (ITT ); Baseline last observation carried forward(BLOCF) imputation was used. | percentage of participants | NUMBER |
| SECONDARY | Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2 | Baseline to Week 2 | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | participants | NUMBER |
| SECONDARY | Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8 | Baseline to Week 8 | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | participants | NUMBER |
| SECONDARY | Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12 | Baseline to Week 12 | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | participants | NUMBER |
| 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 | Baseline to Weeks 2, 8 and 12 | Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used. | units on a scale | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group178
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8 | Capsaicin 8% | -27.44 | Standard Deviation 26.79 | percentage change | |
| Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8 | Placebo | -20.85 | Standard Deviation 28.92 | percentage change | |
| Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12 | Capsaicin 8% | -27.96 | Standard Deviation 27.25 | percentage change | |
| Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12 | Placebo | -21.00 | Standard Deviation 29.42 | percentage change | |
| Weekly Percent Change From Baseline in Average Daily Pain Score | Capsaicin 8% | Week 2 | -22.97 | Standard Deviation 26.24 | percentage change |
| Weekly Percent Change From Baseline in Average Daily Pain Score | Placebo | Week 2 | -19.00 | Standard Deviation 27.99 | percentage change |
| Weekly Percent Change From Baseline in Average Daily Pain Score | Capsaicin 8% | Week 3 | -27.17 | Standard Deviation 27.28 | percentage change |
| Weekly Percent Change From Baseline in Average Daily Pain Score | Placebo | Week 3 | -20.51 | Standard Deviation 29.96 | percentage change |
| Weekly Percent Change From Baseline in Average Daily Pain Score | Capsaicin 8% | Week 4 | -28.18 | Standard Deviation 28.15 | percentage change |
| Weekly Percent Change From Baseline in Average Daily Pain Score | Placebo | Week 4 | -21.11 | Standard Deviation 30.52 | percentage change |
1 to 10 of 178Source ClinicalTrials.gov
See all 178 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Capsaicin 8% | 186 | |
| Overall Study | STARTED | Placebo | 183 | |
| Overall Study | COMPLETED | Capsaicin 8% | 177 | |
| Overall Study | COMPLETED | Placebo | 175 | |
| Overall Study | NOT COMPLETED | Capsaicin 8% | 9 | |
| Overall Study | NOT COMPLETED | Placebo | 8 |
Source ClinicalTrials.gov
Adverse events26
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 | Application site pain | General disorders | Capsaicin 8% | 18 | 186 | |
| other | Application site pain | General disorders | Placebo | 4 | 183 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Capsaicin 8% | 20 | 186 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Placebo | 10 | 183 | |
| other | Burning sensation | Nervous system disorders | Capsaicin 8% | 26 | 186 | |
| other | Burning sensation | Nervous system disorders | Placebo | 5 | 183 | |
| serious | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Capsaicin 8% | 0 | 186 | |
| serious | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Placebo | 2 | 183 | |
| serious | Coronary artery disease | Cardiac disorders | Capsaicin 8% | 0 | 186 | |
| serious | Coronary artery disease | Cardiac disorders | Placebo | 1 | 183 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Capsaicin 8% | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Capsaicin 8% | 61 | 186 |
| Total, other adverse events | Placebo | 18 | 183 |
| Total, serious adverse events | Capsaicin 8% | 2 | 186 |
| Total, serious adverse events | Placebo | 7 | 183 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27746370 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Capsaicin 8% vs Placebo: serious adverse events |
Source 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/NCT01533428
GET https://conductscience.org/api/trials/v1/NCT01533428/results?page=2