Diabetic Neuropathy, PainfulPhase 3NCT05029297
Study With Two Capsaicin Topic Treatments in Diabetic Neuropathy.
A Phase 3 study testing Capsaicin in people with Diabetic Neuropathy, Painful, run by Arafarma Group, S.A..
Trial summary
Clinical trial of "line extension" of drug ARAFARMADOL® 0.075% cream in a new formulation in topical solution applicable in roll-on and with the same therapeutic indications approved for the cream. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy, Painful
- What is being tested?
- Capsaicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- No sites listed yet
- Study dates
- 4 Nov 2010to 23 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written or oral informed consent with witnesses, before initiating the specific procedures of the protocol.
- Non-pregnant, non-lactating man or woman ≥ 18 years.
- Patients diagnosed with Type I or II Diabetes Mellitus, treated or untreated.
- Patients with a diagnosis of painful peripheral diabetic neuropathy, treated or not treated
- Painful diabetic neuropathy of at least 3 months of evolution with moderate to severe pain ≥ 4 on the VAS scale in the selection phase.
- The pain must have been experienced daily, interfered with daily activities or sleep, and not attributable to psychological origin.
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- Stabilization of pain medication at least during the month prior to the start of treatment. The patient must be prepared to remain in treatment with the same pain medications at the same doses as previous to the start, during the study and in the follow-up phase (24 weeks).
- Intact, non-irritated and dry skin in the painful areas to be treated.
- Patients with the ability to collaborate in the trial.
Who cannot join
- Allergic reactions to capsaicin.
- Patients with neuropathic pain of an etiology other than diabetes.
- Patients with peripheral ischemic pain due to diabetic artery disease.
- Patients with unstable glycemic control (glycosylated Hb ≥ 10.5%).
- Amputation of any part of the lower limb.
- Surgery scheduled during the clinical trial.
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- Mild painful diabetic neuropathy (<4 VAS).
- Other serious pathologies:
- Documented congestive heart failure or systolic dysfunction (LVEF ≤ 50%).
- Previous history of myocardial infarction in the 6 months prior to enrollment.
- Uncontrolled hypertension (160/110 mmHg maximum).
- Uncontrolled high-risk arrhythmias.
- Significant neurological or psychiatric disorders, including psychotic disorders, dementia that prevent patients from understanding and giving informed consent.
- Active uncontrolled infection.
- Use other topical pain medications in painful areas.
- History or current problem of substance abuse.
- Pregnant or lactating women. Women of childbearing potential should use effective contraception.
- Participation in another clinical trial with any non-marketed investigational drug during the 90 days prior to inclusion.
About this study
Official title: Study of Efficacy and Non-inferiority, With Two Capsaicin Topic Treatments, for the Moderate to Severe Pain in Diabetic Neuropathy.
Clinical trial of "line extension" of drug ARAFARMADOL® 0.075% cream in a new formulation in topical solution applicable in roll-on and with the same therapeutic indications approved for the cream.
Read the detailed description
The sponsor created a new pharmaceutical formulation of CAPSAICIN topical solution applicable in roll-on. This new formulation in roll-on represents a line extension of drug ARAFARMADOL 0.075 cream, which is currently marketed in Spain by the sponsor.
The proposed investigational product as topical solution applicable in roll-on is expected to solve the compliance and safety issues of the cream with the same indications for use.
Eligible patients will be randomized into two groups: CAPSAICIN topical solution applicable in roll-on and CAPSAICIN cream (ARAFARMADOL® ) for 8 weeks. Then, they will have a 4 week washout period and will be crossed over to the other treatment group for 8 weeks. A follow-up period of 2 weeks will take place after the end of both treatments.
- Conditions
- Diabetic Neuropathy, Painful
- Being tested
- Capsaicin
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinDrug
| Study group | Role | What they receive |
|---|---|---|
| CAPSAICIN 0.75 mg/g topical solution applicable in roll-on | Experimental | CAPSAICIN 0.75 mg / g topical solution applicable in roll-on: 4 applications per day for 8 weeks. Receives: Drug: Capsaicin |
| CAPSAICIN 0.075% cream | Active comparator | CAPSAICIN 0.075% cream (ARAFARMADOL® 0.075% cream): 4 applications per day for 8 weeks. Receives: Drug: Capsaicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the efficacy and the non-inferiority of a new formulation of the capsaicin topical solution in "roll-on" compared to capsaicin in cream.
To demonstrate the efficacy and the non-inferiority of a new formulation of Capsaicin 0.75 mg / g topical solution applicable in "roll-on" compared to the formulation currently marketed (comparator) in cream (Arafarmadol® 0.075% cream). The main variable will be the decrease in pain on the visual analogue pain scale (score range from 0 (no pain) to 10 (worst pain possible) at 8 weeks of treatment with each drug. The change in efficacy between the two treatments (pain reduction with cream minus pain reduction with roll-on) will be calculated and the 95% confidence interval for this change will be obtained; If the confidence interval does not exceed the non-inferiority limit (1.0), it will be concluded that the new formulation is not inferior to the one currently marketed.
Measured: Baseline to 8 weeks
Secondary outcomes (8)
Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) between both treatment groups.
All AEs will be recorded, whether considered minor or serious, drug-related or not.
Measured: From Visit 1, and at each visit, up to 22 weeks.
Change from baseline in both treatment groups of QoL.
The EQ-5D consists of 2 parts - the descriptive part and the visual scale analog (EVA). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, habitual activities, pain / discomfort, and anxiety / depression. In the EVA the patient scores their health between two extremes, 0 and 100, worst and best health status imaginable.
Measured: Baseline to 8 weeks
Treatment compliance in both treatment groups.
Treatment compliance is measured by the use of Morisky-Green test.
Measured: At the end of each treatment phase (8th week).
Change from baseline in both treatment groups of height.
Height measured by cm.
Measured: Baseline to every 4 weeks up to 22 weeks.
Change from baseline in both treatment groups of weight.
Weight measured by kg.
Measured: Baseline to every 4 weeks up to 22 weeks.
Change from baseline in both treatment groups of blood pressure.
Blood pressure measured by mm Hg.
Measured: Baseline to every 4 weeks up to 22 weeks.
Change from baseline in both treatment groups of dermatological assessment of the painful area.
Dermatological assessment is measured by Dermatological Assessment Scale (scale range from 0 (without causing irritation) to 7 (important reaction that extends beyond the assessed area).
Measured: Baseline to 8 weeks.
Grade of compliance/complacency of treatment.
A patient compliance questionnaire (6 questions) will be self-administered to the patient and must be completed during the follow-up visit.
Measured: Last Follow-Up visit of the study (22nd week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start4 Nov 2010
- Primary completion23 Oct 2018
- Study completion23 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Neuropathy, PainfulStudies 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
- Patients will receive one of the two interventions (CAPSAICIN topical solution and cream) during the initial phase of the study of 8 weeks and receive the other intervention during the second phase of the study of 8 weeks. Both phases will be separated in a 4 week washout period.
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arafarma Group, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fundación Teófilo Hernando, Spain
- Responsible party
- Sponsor
- Investigators
- Dr. Raffaelle Carraro, Principal investigator, Hospital Universitario La Princesa. Madrid. Investigator Site Coordinator.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029297
- Sponsor's protocol ID
- ITHUEC-CAP/10-5
- Status last verified
- Mar 2021
- First submitted
- 19 May 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Efficacy and Non-inferiority, With Two Capsaicin Topic Treatments, for the Moderate to Severe Pain in Diabetic Neuropathy.
- ClinicalTrials.gov ID
- NCT05029297
- Acronym / sponsor ID
- ITHUEC-CAP/10-5
- Conditions
- Diabetic Neuropathy, Painful
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Arafarma Group, S.A.Industry (pharma, biotech, devices)
- Collaborators
- Fundación Teófilo Hernando, Spain
- Study start
- 4 Nov 2010 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 23 Oct 2018 (actual)
- First posted
- 31 Aug 2021 (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.
Clinical trial of "line extension" of drug ARAFARMADOL® 0.075% cream in a new formulation in topical solution applicable in roll-on and with the same therapeutic indications approved for the cream.
Detailed description
The sponsor created a new pharmaceutical formulation of CAPSAICIN topical solution applicable in roll-on. This new formulation in roll-on represents a line extension of drug ARAFARMADOL 0.075 cream, which is currently marketed in Spain by the sponsor.
The proposed investigational product as topical solution applicable in roll-on is expected to solve the compliance and safety issues of the cream with the same indications for use.
Eligible patients will be randomized into two groups: CAPSAICIN topical solution applicable in roll-on and CAPSAICIN cream (ARAFARMADOL® ) for 8 weeks. Then, they will have a 4 week washout period and will be crossed over to the other treatment group for 8 weeks. A follow-up period of 2 weeks will take place after the end of both treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will receive one of the two interventions (CAPSAICIN topical solution and cream) during the initial phase of the study of 8 weeks and receive the other intervention during the second phase of the study of 8 weeks. Both phases will be separated in a 4 week washout period.
| Arm | Type | Receives |
|---|---|---|
| CAPSAICIN 0.75 mg/g topical solution applicable in roll-on | Experimental | Drug: CapsaicinCAPSAICIN 0.75 mg / g topical solution applicable in roll-on: 4 applications per day for 8 weeks. |
| CAPSAICIN 0.075% cream | Active comparator | Drug: CapsaicinCAPSAICIN 0.075% cream (ARAFARMADOL® 0.075% cream): 4 applications per day for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written or oral informed consent with witnesses, before initiating the specific procedures of the protocol.
- Non-pregnant, non-lactating man or woman ≥ 18 years.
- Patients diagnosed with Type I or II Diabetes Mellitus, treated or untreated.
- Patients with a diagnosis of painful peripheral diabetic neuropathy, treated or not treated
- Painful diabetic neuropathy of at least 3 months of evolution with moderate to severe pain ≥ 4 on the VAS scale in the selection phase.
Key exclusion criteria (18 listed)
- Allergic reactions to capsaicin.
- Patients with neuropathic pain of an etiology other than diabetes.
- Patients with peripheral ischemic pain due to diabetic artery disease.
- Patients with unstable glycemic control (glycosylated Hb ≥ 10.5%).
- Amputation of any part of the lower limb.
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 | Drug | CAPSAICIN 0.075% cream, CAPSAICIN 0.75 mg/g topical solution applicable in roll-on |
Primary outcome
To demonstrate the efficacy and the non-inferiority of a new formulation of the capsaicin topical solution in "roll-on" compared to capsaicin in cream.
Time frame: Baseline to 8 weeks
To demonstrate the efficacy and the non-inferiority of a new formulation of Capsaicin 0.75 mg / g topical solution applicable in "roll-on" compared to the formulation currently marketed (comparator) in cream (Arafarmadol® 0.075% cream). The main variable will be the decrease in pain on the visual analogue pain scale (score range from 0 (no pain) to 10 (worst pain possible) at 8 weeks of treatment with each drug. The change in efficacy between the two treatments (pain reduction with cream minus pain reduction with roll-on) will be calculated and the 95% confidence interval for this change will be obtained; If the confidence interval does not exceed the non-inferiority limit (1.0), it will be concluded that the new formulation is not inferior to the one currently marketed.
8 secondary outcomes
Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) between both treatment groups.
Time frame: From Visit 1, and at each visit, up to 22 weeks.
Change from baseline in both treatment groups of QoL.
Time frame: Baseline to 8 weeks
Treatment compliance in both treatment groups.
Time frame: At the end of each treatment phase (8th week).
Change from baseline in both treatment groups of height.
Time frame: Baseline to every 4 weeks up to 22 weeks.
Change from baseline in both treatment groups of weight.
Time frame: Baseline to every 4 weeks up to 22 weeks.
Change from baseline in both treatment groups of blood pressure.
Time frame: Baseline to every 4 weeks up to 22 weeks.
Change from baseline in both treatment groups of dermatological assessment of the painful area.
Time frame: Baseline to 8 weeks.
Grade of compliance/complacency of treatment.
Time frame: Last Follow-Up visit of the study (22nd 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 14 Sep 2021.
- 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.
Dr. Raffaelle Carraro principal investigator
Hospital Universitario La Princesa. Madrid. Investigator Site Coordinator.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capsaicin in people with Diabetic Neuropathy, Painful, run by Arafarma Group, S.A..
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 9 inclusion and 18 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 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
To demonstrate the efficacy and the non-inferiority of a new formulation of the capsaicin topical solution in "roll-on" compared to capsaicin in cream. (time frame: Baseline to 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 14 Sep 2021.