Peripheral Diabetic NeuropathyPhase 3NCT03113448
0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy
A Phase 3 study testing 0.075% Capsaicin Lotion in people with Peripheral Diabetic Neuropathy, run by Thammasat University at 1 site in Thailand.
Trial summary
To study that 0.075% capsaicin lotion is safe, well tolerated and provide significant pain relief in patients with PDN compared with placebo lotion as a randomized, double- Blind, crossover, placebo-controlled trial Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peripheral Diabetic Neuropathy
- What is being tested?
- 0.075% Capsaicin Lotion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteThailand
- Study dates
- 19 Jan 2017to 31 Jan 2018
- Phase
- Phase 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
- DM type 2 over 1 year
- Clinical presentation of peripheral sensory such as burning pain
- DN4 score from 4 points
- Good consciousness to tell their score with informed consent agreement
- No adding dosage of previous pain control medications at least 4 weeks
- HbA1C 6.5-9.0%
Who cannot join
- Improper application site of skin for topical drugs such as abrasion wound.
- Allergic history of Capsaicin
- No intention to join the study with any reasons
- Other previous medications used that effect to peripheral neuropathy such as Carboplatin, Cisplatin, Colchicine, Dapsone, Etoposide, Ethambutol, Indomethacin, Isoniazid, Lithium, Metronidazole, Phenytoin, Pyridoxine, Statins, Stavudine (d4T) or conditions worsening peripheral nerves following that poor nutrition, kidney failure, chronic alcoholism, vitamin deficiency, Hypothyroidism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy: A Randomized, Double- Blind, Crossover, Placebo-Controlled Trial
To study that 0.075% capsaicin lotion is safe, well tolerated and provide significant pain relief in patients with PDN compared with placebo lotion as a randomized, double- Blind, crossover, placebo-controlled trial
Read the detailed description
Neuropathy is one of the most common complications in both type 1 and type 2 diabetes mellitus. The most common symptom is a symmetrical, chronic, axonal, length-dependent sensorimotor polyneuropathy.
Topical capsaicin formulations are widely used to manage pain. Low-concentration creams, lotions, and patches intended for daily skin application have been available in most countries since the early 1980s.
We study 0.075% capsaicin lotion is safe, well tolerated and provide significant pain relief in patients with PDN compared with placebo lotion as a randomized, double- Blind, crossover, placebo-controlled trial for 20 weeks throughout the study in 42 participants. All participants are provided both 0.075% capsaicin lotion and placebo lotion. Each agent will be applied for 8 weeks then stop for 4 weeks, after that another agent will be used for 8 weeks. We keep following up all of them by calling and appointment to get information in effectiveness and adverse effect at 0,2,4,8,12,14,16,20 week, respectively.
- Conditions
- Peripheral Diabetic Neuropathy
- Being tested
- 0.075% Capsaicin Lotion, placebo
- Keywords
- capsaicin, neuropathic pain, diabetic neuropathy, topical lotion
- Medical subject headings
- Neuralgia, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.075% Capsaicin LotionDrug
To apply 3-4 times per day, every day until 8 weeks then stop
placeboDrug
To apply 3-4 times per day, every day until 8 weeks then stop
| Study group | Role | What they receive |
|---|---|---|
| 0.075% Capsaicin Lotion | Active comparator | 0.075% Capsaicin Lotion is used for application at skin area involved with symptomatic neuropathic pain (both feet or/and hands), 3-4 times a day, everyday for 8 weeks then stop Receives: Drug: 0.075% Capsaicin Lotion; Drug: placebo |
| Placebo Lotion | Placebo comparator | Placebo Lotion is used for application at skin area involved with symptomatic neuropathic pain (both feet or/and hands), 3-4 times a day, everyday for 8 weeks then stop Receives: Drug: 0.075% Capsaicin Lotion; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (0-100 mm.)
scale
Measured: 20 week
Secondary outcomes (2)
Short-form McGill Pain Questionnaire(SF-MPQ)
scale
Measured: 20 week
Neuropathic Pain Scale (NPS)
scale
Measured: 20 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start19 Jan 2017
- Primary completion21 Apr 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Diabetic 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
- Crossover
- Model description
- Randomized controlled trial, double blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assawin Chomjit, Thammasat University
- Investigators
- Kongkiat Kulkantrakorn, Professor, Study chair, Thammasat University HospitalPasiri Sithinamsuwan, Study director, Phramongkutklao College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113448
- Sponsor's protocol ID
- MTU-EC-IM-5-195/59
- Other IDs
- TCTR20170407001
- Status last verified
- Sep 2018
- First submitted
- 9 Apr 2017
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.
PubMed 36729473
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy: A Randomized, Double- Blind, Crossover, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT03113448
- Acronym / sponsor ID
- MTU-EC-IM-5-195/59
- Conditions
- Peripheral Diabetic Neuropathy
- Keywords
- capsaicin, neuropathic pain, diabetic neuropathy, topical lotion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 21 Apr 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 13 Apr 2017 (actual)
- 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.
To study that 0.075% capsaicin lotion is safe, well tolerated and provide significant pain relief in patients with PDN compared with placebo lotion as a randomized, double- Blind, crossover, placebo-controlled trial
Detailed description
Neuropathy is one of the most common complications in both type 1 and type 2 diabetes mellitus. The most common symptom is a symmetrical, chronic, axonal, length-dependent sensorimotor polyneuropathy.
Topical capsaicin formulations are widely used to manage pain. Low-concentration creams, lotions, and patches intended for daily skin application have been available in most countries since the early 1980s.
We study 0.075% capsaicin lotion is safe, well tolerated and provide significant pain relief in patients with PDN compared with placebo lotion as a randomized, double- Blind, crossover, placebo-controlled trial for 20 weeks throughout the study in 42 participants. All participants are provided both 0.075% capsaicin lotion and placebo lotion. Each agent will be applied for 8 weeks then stop for 4 weeks, after that another agent will be used for 8 weeks. We keep following up all of them by calling and appointment to get information in effectiveness and adverse effect at 0,2,4,8,12,14,16,20 week, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial, double blind
| Arm | Type | Receives |
|---|---|---|
| 0.075% Capsaicin Lotion | Active comparator | Drug: 0.075% Capsaicin Lotion, Drug: placebo0.075% Capsaicin Lotion is used for application at skin area involved with symptomatic neuropathic pain (both feet or/and hands), 3-4 times a day, everyday for 8 weeks then stop |
| Placebo Lotion | Placebo comparator | Drug: 0.075% Capsaicin Lotion, Drug: placeboPlacebo Lotion is used for application at skin area involved with symptomatic neuropathic pain (both feet or/and hands), 3-4 times a day, everyday for 8 weeks then stop |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- DM type 2 over 1 year
- Clinical presentation of peripheral sensory such as burning pain
- DN4 score from 4 points
- Good consciousness to tell their score with informed consent agreement
- No adding dosage of previous pain control medications at least 4 weeks
Key exclusion criteria (4 listed)
- Improper application site of skin for topical drugs such as abrasion wound.
- Allergic history of Capsaicin
- No intention to join the study with any reasons
- Other previous medications used that effect to peripheral neuropathy such as Carboplatin, Cisplatin, Colchicine, Dapsone, Etoposide, Ethambutol, Indomethacin, Isoniazid, Lithium, Metronidazole, Phenytoin, Pyridoxine, Statins, Stavudine (d4T) or conditions worsening peripheral nerves following that poor nutrition, kidney failure, chronic alcoholism, vitamin deficiency, Hypothyroidism
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 |
|---|---|---|
| 0.075% Capsaicin LotionTo apply 3-4 times per day, every day until 8 weeks then stop | Drug | 0.075% Capsaicin Lotion, Placebo Lotion |
| placeboTo apply 3-4 times per day, every day until 8 weeks then stop | Drug | 0.075% Capsaicin Lotion, Placebo Lotion |
Primary outcome
Visual analog scale (0-100 mm.)
Time frame: 20 week
scale
2 secondary outcomes
Short-form McGill Pain Questionnaire(SF-MPQ)
Time frame: 20 week
Neuropathic Pain Scale (NPS)
Time frame: 20 week
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 12 Sep 2018.
- Derived from this study: PubMed 36729473Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.
- Individual participant dataSharing planned: No
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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, Professor study chair
Thammasat University Hospital
Pasiri Sithinamsuwan study director
Phramongkutklao College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.075% Capsaicin Lotion in people with Peripheral Diabetic Neuropathy, 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 6 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 12 Sep 2018. 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 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?
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?
Visual analog scale (0-100 mm.) (time frame: 20 week). 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 NCT03113448, 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 12 Sep 2018.