Painful Diabetic NeuropathyPhase 2/3NCT01125215
Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy
A Phase 2/3 study testing 0.75% capsaicin nanoparticle cream in people with Painful Diabetic Neuropathy, run by Mahidol University at 2 sites in Thailand.
Trial summary
The objectives of this study are to determine efficacy and safety of 0.75% topical capsaicin nanoparticle preparation versus placebo in patient with painful diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Diabetic Neuropathy
- What is being tested?
- 0.75% capsaicin nanoparticle cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesThailand
- Study dates
- Sep 2009to Dec 2013
- 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 18 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 any 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
2 sites in 1 country.
Thailand2 sites
Ramathibodi Hospital
Bangkok, Bangkok, 10400
Thammasat University Hospital
Pathum Thani, Changwat Pathum Thani, 12120
About this study
Official title: Study of Topical Preparation of Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy
The objectives of this study are to determine efficacy and safety of 0.75% topical capsaicin nanoparticle preparation versus placebo in patient with painful diabetic neuropathy.
Read the detailed description
Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain. Because of high concentration, conventional capsaicin topical preparation causing burning sensation and required several time of applications per day.
The nanoparticle of capsaicin topical preparation was developed with expectation of remaining efficacy, minimizing burning sensation and improving convenience of use.
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- 0.75% capsaicin nanoparticle cream, Placebo
- Keywords
- Painful diabetic neuropathy, Capsaicin, Nanoparticle, Quantitative Sensory Testing
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.75% capsaicin nanoparticle creamDrug
0.75% capsaicin nanoparticle cream apply to area with neuropathic pain twice daily for 12 weeks
PlaceboDrug
Identical cream base of nanoparticle apply to area with neuropathic pain twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matched gel base of capsaicin nanoparticle Receives: Drug: Placebo |
| Capsaicin | Experimental | 0.075% capsaicin nanoparticle gel Receives: Drug: 0.75% capsaicin nanoparticle cream |
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: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startSep 2009
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic NeuropathyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Thailand Research Fund
- Responsible party
- Principal investigator, Pongsatorn Meesawatsom, Mahidol University
- Investigators
- Chuthamanee Suthisisang, PhD., Study director, Faculty of Pharmacy,Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125215
- Sponsor's protocol ID
- MUPYPM-01
- Status last verified
- Apr 2013
- First submitted
- 15 May 2010
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Topical Preparation of Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT01125215
- Acronym / sponsor ID
- MUPYPM-01
- Conditions
- Painful Diabetic Neuropathy
- Keywords
- Painful diabetic neuropathy, Capsaicin, Nanoparticle, Quantitative Sensory Testing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Thailand Research Fund
- Study start
- Sep 2009
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 18 May 2010 (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.
The objectives of this study are to determine efficacy and safety of 0.75% topical capsaicin nanoparticle preparation versus placebo in patient with painful diabetic neuropathy.
Detailed description
Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain. Because of high concentration, conventional capsaicin topical preparation causing burning sensation and required several time of applications per day.
The nanoparticle of capsaicin topical preparation was developed with expectation of remaining efficacy, minimizing burning sensation and improving convenience of use.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboMatched gel base of capsaicin nanoparticle |
| Capsaicin | Experimental | Drug: 0.75% capsaicin nanoparticle cream0.075% capsaicin nanoparticle gel |
Who may qualify
- Ages
- 18 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 any 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 |
|---|---|---|
| 0.75% capsaicin nanoparticle cream0.75% capsaicin nanoparticle cream apply to area with neuropathic pain twice daily for 12 weeks | Drug | Capsaicin |
| PlaceboIdentical cream base of nanoparticle apply to area with neuropathic pain twice daily for 12 weeks | Drug | Placebo |
Primary outcome
Pain relief from pain score reduction, using visual analog scale (VAS)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
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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.
Chuthamanee Suthisisang, PhD. study director
Faculty of Pharmacy,Mahidol University
2 sites 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 0.75% capsaicin nanoparticle cream in people with Painful Diabetic Neuropathy, run by Mahidol University at 2 sites 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: status not confirmed, as of the sponsor's last update on 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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: 12 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 11 Apr 2013.