Diabetic PolyneuropathyPhase 2/3NCT00993070
Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy
A Phase 2/3 study testing Capsaicin in people with Diabetic Polyneuropathy, run by Thammasat University at 1 site in Thailand.
Trial summary
Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain, but there is no data in lower concentration. This is the efficacy and safety of 0.025% topical capsaicin in treatment of painful diabetic polyneuropathy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetic Polyneuropathy
- What is being tested?
- Capsaicin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2009to Dec 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of type 2 Diabetes mellitus
- Peripheral neuropathy
- Stabilized on pain medication for at least one month
- No previous invasive intervention for pain relief
Who cannot join
- Local wound or skin abnormality in the applicable area
- Allergic to capsaicin
- Refuse to participate or give consent
- Has other significant disease or receive medication that may worsen neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Crossover, Double Blinded, Placebo Controlled Trial of Topical Capsaicin in Treatment of Painful Diabetic Neuropathy
Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain, but there is no data in lower concentration. This is the efficacy and safety of 0.025% topical capsaicin in treatment of painful diabetic polyneuropathy.
Read the detailed description
Patient is randomized to receive either 0.025% topical capsaicin or vehicle control (placebo) for 8 weeks. After one week wash-out period, patients will be switched to the other group for 8 weeks.
Outcome will be assessed by visual analog scale, neuropathic pain scale, SF-MPQ, SF-36. Safety and tolerability will be recorded.
- Conditions
- Diabetic Polyneuropathy
- Being tested
- Capsaicin, placebo
- Keywords
- capsaicin, placebo, trial, diabetic polyneuropathy, neuropathic pain
- Medical subject headings
- Diabetic Neuropathies, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinDrug
Also called Capsika gel
0.025% topical capsaicin applied 4 times per day for 8 weeks
placeboDrug
vehicle gel, applied 4 times per day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin | Experimental | Not described Receives: Drug: Capsaicin |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief from pain score reduction, using visual analog scale (VAS)
Measured: 8 weeks
Secondary outcomes (1)
Overall clinical improvement, measured by Clinician Global Impression of Change(CGIC)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Collaborators
- Bangkok Drug company
- Responsible party
- Principal investigator, Kongkiat Kulkantrakorn, Thammasat University
- Investigators
- Kongkiat Kulkantrakorn, MD, Principal investigator, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993070
- Sponsor's protocol ID
- MTU-I-1-45/52
- Status last verified
- May 2012
- First submitted
- 7 Oct 2009
- Last updated
- 9 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover, Double Blinded, Placebo Controlled Trial of Topical Capsaicin in Treatment of Painful Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT00993070
- Acronym / sponsor ID
- MTU-I-1-45/52
- Conditions
- Diabetic Polyneuropathy
- Keywords
- capsaicin, placebo, trial, diabetic polyneuropathy, neuropathic pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Collaborators
- Bangkok Drug company
- Study start
- Oct 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain, but there is no data in lower concentration. This is the efficacy and safety of 0.025% topical capsaicin in treatment of painful diabetic polyneuropathy.
Detailed description
Patient is randomized to receive either 0.025% topical capsaicin or vehicle control (placebo) for 8 weeks. After one week wash-out period, patients will be switched to the other group for 8 weeks.
Outcome will be assessed by visual analog scale, neuropathic pain scale, SF-MPQ, SF-36. Safety and tolerability will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsaicin | Experimental | Drug: Capsaicin |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of type 2 Diabetes mellitus
- Peripheral neuropathy
- Stabilized on pain medication for at least one month
- No previous invasive intervention for pain relief
Key exclusion criteria (4 listed)
- Local wound or skin abnormality in the applicable area
- Allergic to capsaicin
- Refuse to participate or give consent
- Has other significant disease or receive medication that may worsen neuropathy
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 |
|---|---|---|
| CapsaicinAlso: Capsika gel0.025% topical capsaicin applied 4 times per day for 8 weeks | Drug | Capsaicin |
| placebovehicle gel, applied 4 times per day for 8 weeks | Drug | placebo |
Primary outcome
Pain relief from pain score reduction, using visual analog scale (VAS)
Time frame: 8 weeks
1 secondary outcome
Overall clinical improvement, measured by Clinician Global Impression of Change(CGIC)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2012.
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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.
Kongkiat Kulkantrakorn, MD principal investigator
Thammasat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Capsaicin in people with Diabetic Polyneuropathy, run by Thammasat University at 1 site in Thailand.
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 4 inclusion and 4 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 9 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain relief from pain score reduction, using visual analog scale (VAS) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2012.