Diabetic Peripheral NeuropathyPhase 3STEPNCT01533428
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)
A Phase 3 study testing Capsaicin 8% in people with Diabetic Peripheral Neuropathy and Pain, run by Astellas Pharma Inc at 29 sites in United States.
Trial summary
The purpose of the study is to assess efficacy and safety of a single treatment of Capsaicin 8% transdermal delivery system in reducing pain from damaged nerves (neuropathic pain) caused by diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathy, Pain
- What is being tested?
- Capsaicin 8%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 369 participants
- Where
- 29 sitesUnited States
- Study dates
- Feb 2012to Feb 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes, for at least 1 year prior to screening visit
- Average Numeric Pain Rating Scale (NPRS) score over the last 24 hours of ≥4 at the screening and the baseline visit
Who cannot join
- Primary pain associated with PDPN (Painful Diabetic Peripheral Neuropathy) in the ankles or above
- Pain that could not be clearly differentiated from, or conditions that might interfere with the assessment of PDPN (Painful Diabetic Peripheral Neuropathy), neurological disorders unrelated to diabetic neuropathy (e.g., phantom limb pain from amputation); skin condition in the area of the neuropathy that could alter sensation (e.g., plantar ulcer)
- Current or previous foot ulcer as determined by medical history and medical examination
- Any amputation of lower extremity
- Severe renal disease as defined by a creatinine clearance of <30 ml/min calculated according to the Cockcroft-Gault formula
- Clinically significant cardiovascular disease within 6 months prior to screening visit defined as cerebrovascular accident, unstable or poorly controlled hypertension, transient ischemic attack, myocardial infarction, unstable angina, current arrhythmia, any heart surgery including coronary artery bypass graft surgery, percutaneous coronary angioplasty/stent placement, or valvular heart disease
Show all 16Show fewer
- Significant peripheral vascular disease (intermittent claudication or lack of pulsation of either the dorsalis pedis or posterior tibial artery, or ankle-brachial systolic blood pressure index of <0.80)
- Clinically significant foot deformities, including hallux rigidus, hallux valgus, or rigid toe as determined by physical examination as judged by the investigator
- Clinically significant ongoing, uncontrolled or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may interfere either with the ability to complete the study or the evaluation of adverse events
- Diagnosis of any poorly controlled major psychiatric disorder
- Active substance abuse or history of chronic substance abuse within 1 year prior to screening visit or any prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator
- Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter [OTC] capsaicin products), any Capsaicin 8% transdermal delivery system excipients, Eutectic Mixture of Local Anaesthetics (EMLA) ingredients or adhesives
- Use of any topical pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics, steroids or capsaicin products on the painful areas within 7 days preceding the first patch application at the baseline visit
- Use of oral or transdermal opioids exceeding a total daily dose of morphine of 80 mg/day, or equivalent; or any parenteral opioids, regardless of dose, within 7 days preceding the first patch application at the baseline visit
- Skin areas to be treated with Capsaicin 8% transdermal delivery system showing changes such as crusting or ulcers
- Planned elective surgery during the trial
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Site: 115
Ann Arbor, Michigan, 48104
Site: 125
Anniston, Alabama, 36207
Site: 117
Boynton Beach, Florida, 33435
Site: 124
Bradenton, Florida, 34205
Site: 107
Clearwater, Florida, 33765
Site:106
Dallas, Texas, 75230
Site: 131
Fresno, California, 93720
Site: 128
Hazelwood, Missouri, 63042
Site: 133
Honolulu, Hawaii, 96814
Site: 118
Houston, Texas, 77030
Site: 114
Houston, Texas, 77098
Site: 120
Jupiter, Florida, 33458
Site: 121
Kettering, Ohio, 45429
Site: 123
Long Beach, California, 90806
Site: 116
Los Angeles, California, 90033
Site: 103
Lubbock, Texas, 79410
Site: 113
Milford, Connecticut, 06460
Site: 126
New Bedford, Massachusetts, 02740
Site: 119
New London, Connecticut, 06320
Site:111
New York, New York, 10029
Site: 112
Orange, California, 92868
Site: 108
Orlando, Florida, 32806
Site: 132
Oviedo, Florida, 32765
Site: 105
San Antonio, Texas, 78228
Site: 102
San Antonio, Texas, 78229
Site: 127
St. Petersburg, Florida, 33709
Site: 122
Tampa, Florida, 33606
Site: 130
Walnut Creek, California, 94597
Site: 110
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of QUTENZA® in Subjects With Painful Diabetic Peripheral Neuropathy
The purpose of the study is to assess efficacy and safety of a single treatment of Capsaicin 8% transdermal delivery system in reducing pain from damaged nerves (neuropathic pain) caused by diabetes.
Read the detailed description
Participants were divided into 2 groups of approximately equal size. In the first group, participants received a Capsaicin 8% patch applied for 30 minutes to the feet; in the second group, participants received a placebo patch applied for 30 minutes to the feet. Participants were involved in the study for approximately 12 weeks and have visited the clinic approximately 6 times.
- Conditions
- Diabetic Peripheral Neuropathy, Pain
- Being tested
- Capsaicin 8%, Placebo
- Keywords
- Painful Diabetic Peripheral Neuropathy,, Capsaicin 8% transdermal delivery system
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin 8%Drug
Also called Qutenza
Capsaicin 8% transdermal delivery system
PlaceboDrug
Placebo Patch
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin 8% | Experimental | Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 Receives: Drug: Capsaicin 8% |
| Placebo | Placebo comparator | Placebo patch was applied for 30 minutes to the painful area(s) on Day 1 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to between Weeks 2 to 8
Secondary outcomes (17)
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).
Measured: Baseline to between Weeks 2 and 12
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).
Measured: Baseline to Weeks 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12
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).
Measured: Baseline and Weeks 2, 4, 8 and 12
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).
Measured: Baseline, Weeks 2-8 and Weeks 2-12
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).
Measured: Baseline, Weeks 2-8 and Weeks 2-12
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
Measured: Baseline to Week 2
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
Measured: Baseline to Week 8
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
Measured: Baseline to Week 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
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).
Measured: Baseline to Weeks 2, 8 and 12
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.
Measured: Baseline to Weeks 2, 8 and 12
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.
Measured: Baseline to Weeks 2, 8 and 12
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?"
Measured: Baseline, Weeks 8 and 12
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.
Measured: Baseline, Weeks 2-8 and Weeks 2-12
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.
Measured: Day 1, 15 minutes and 60 minutes after patch removal
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.
Measured: Pre-application and 15 minutes and 60 minutes after patch removal
Number of Participants Who Used Rescue Pain Medication Days 1 Through 5
Summarized number of participants who used Rescue Pain Medications for Pain
Measured: Days 1 - 5
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
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Manager, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533428
- Sponsor's protocol ID
- E05-CL-3004
- Acronym
- STEP
- Status last verified
- Oct 2015
- First submitted
- 12 Feb 2012
- Last updated
- 4 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Simpson DM, Robinson-Papp J, Van J, Stoker M, Jacobs H, Snijder RJ, Schregardus DS, Long SK, Lambourg B, Katz N. Capsaicin 8% Patch in Painful Diabetic Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Study. J Pain. 2017 Jan;18(1):42-53. doi: 10.1016/j.jpain.2016.09.008. Epub 2016 Oct 13.
PubMed 27746370
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of QUTENZA® in Subjects With Painful Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT01533428
- Acronym / sponsor ID
- STEP / E05-CL-3004
- Conditions
- Diabetic Peripheral Neuropathy, Pain
- Keywords
- Painful Diabetic Peripheral Neuropathy,, Capsaicin 8% transdermal delivery system
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 15 Feb 2012 (estimated)
- Results
- Posted 13 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess efficacy and safety of a single treatment of Capsaicin 8% transdermal delivery system in reducing pain from damaged nerves (neuropathic pain) caused by diabetes.
Detailed description
Participants were divided into 2 groups of approximately equal size. In the first group, participants received a Capsaicin 8% patch applied for 30 minutes to the feet; in the second group, participants received a placebo patch applied for 30 minutes to the feet. Participants were involved in the study for approximately 12 weeks and have visited the clinic approximately 6 times.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsaicin 8% | Experimental | Drug: Capsaicin 8%Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo patch was applied for 30 minutes to the painful area(s) on Day 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes, for at least 1 year prior to screening visit
- Average Numeric Pain Rating Scale (NPRS) score over the last 24 hours of ≥4 at the screening and the baseline visit
Key exclusion criteria (16 listed)
- Primary pain associated with PDPN (Painful Diabetic Peripheral Neuropathy) in the ankles or above
- Pain that could not be clearly differentiated from, or conditions that might interfere with the assessment of PDPN (Painful Diabetic Peripheral Neuropathy), neurological disorders unrelated to diabetic neuropathy (e.g., phantom limb pain from amputation); skin condition in the area of the neuropathy that could alter sensation (e.g., plantar ulcer)
- Current or previous foot ulcer as determined by medical history and medical examination
- Any amputation of lower extremity
- Severe renal disease as defined by a creatinine clearance of <30 ml/min calculated according to the Cockcroft-Gault formula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsaicin 8%Also: QutenzaCapsaicin 8% transdermal delivery system | Drug | Capsaicin 8% |
| PlaceboPlacebo Patch | Drug | Placebo |
Primary outcome
Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8
Time frame: 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).
17 secondary outcomes
Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12
Time frame: Baseline to between Weeks 2 and 12
Weekly Percent Change From Baseline in Average Daily Pain Score
Time frame: Baseline to Weeks 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12
Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline
Time frame: Baseline and Weeks 2, 4, 8 and 12
Percentage of Participants With 30% Reduction in Average Daily Pain Score.
Time frame: Baseline, Weeks 2-8 and Weeks 2-12
Percentage of Participants With 50% Reduction in Average Daily Pain Score.
Time frame: Baseline, Weeks 2-8 and Weeks 2-12
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2
Time frame: Baseline to Week 2
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8
Time frame: Baseline to Week 8
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12
Time frame: Baseline to Week 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
Time frame: Baseline to Weeks 2, 8 and 12
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Scale From Baseline to Weeks 2, 8 and 12
Time frame: Baseline to Weeks 2, 8 and 12
Change in Hospital Anxiety and Depression Scale (HADS) Depression Scale From Baseline to Weeks 2, 8 and 12.
Time frame: Baseline to Weeks 2, 8 and 12
Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12
Time frame: Baseline, Weeks 8 and 12
Percent Change in Average Sleep Interference Score From Baseline to Between Weeks 2-8 and Weeks 2-12
Time frame: Baseline, Weeks 2-8 and Weeks 2-12
Tolerability of Patch Application Assessed by Dermal Assessment on Day 1, 15 Minutes and 60 Minutes After Patch Removal.
Time frame: Day 1, 15 minutes and 60 minutes after patch removal
Change From Pre-application in"Pain Now" Score
Time frame: Pre-application and 15 minutes and 60 minutes after patch removal
Number of Participants Who Used Rescue Pain Medication Days 1 Through 5
Time frame: Days 1 - 5
Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27746370Simpson DM, Robinson-Papp J, Van J, Stoker M, Jacobs H, Snijder RJ, Schregardus DS, Long SK, Lambourg B, Katz N. Capsaicin 8% Patch in Painful Diabetic Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Study. J Pain. 2017 Jan;18(1):42-53. doi: 10.1016/j.jpain.2016.09.008. Epub 2016 Oct 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Study Manager study chair
Astellas Pharma Europe B.V.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capsaicin 8% in people with Diabetic Peripheral Neuropathy and Pain, run by Astellas Pharma Inc at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8 (time frame: Baseline to between Weeks 2 to 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01533428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2015.