Painful Diabetic Peripheral Neuropathy (PDPN)Phase 3ENFORCENCT06715462
Efficacy and Safety of the N0750 Compared to Monotherapies in the Treatment of Painful Diabetic Peripheral Neuropathy
A Phase 3 study testing N0750, Cymbalta® and Lyrica® in people with Painful Diabetic Peripheral Neuropathy (PDPN), run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
Trial summary
A phase 3, prospective, adaptive, randomized, multicenter, double-blind, triple-masked, parallel clinical trial to evaluate the efficacy and safety of N0750 in relieving pain associated with painful diabetic peripheral neuropathy (PDPN). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Painful Diabetic Peripheral Neuropathy (PDPN)
- What is being tested?
- N0750, Cymbalta® and Lyrica®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2026to Mar 2028
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to confirm voluntary participation and agree to all purposes of the trial, by signing and dating the Informed Consent Form (ICF) in two copies.
- Subjects of both sexes, aged between 18 and 80 years.
- Previous diagnosis of type 1 diabetes mellitus or type 2 diabetes mellitus.
- Subjects diagnosed with PDPN for at least 3 months, confirmed by NSS ≥ 5 points and NIS ≥ 3 points.
- Subjects who agree to discontinue current PDPN treatment during the washout period.
- Subjects willing and able to comply with all study requirements, including completion of study diary and questionnaires.
Who cannot join
- Painful peripheral neuropathy due to other causes, e.g. B12 and/or folate deficiency and hypothyroidism.
- Previous diagnosis of other types of pain not related to PDPN, which at the Investigator's discretion, may confound the assessment of clinical trial endpoints, such as, but not limited to: peripheral vascular disease (ischemic pain); neurological disorders unrelated to diabetic neuropathy (phantom pain due to limb amputation); other painful conditions (e.g., arthritis).
- Skin changes in the PDPN area that may cause changes in sensitivity or preclude physical assessment, e.g.: plantar ulcer.
- Subjects with any other clinically significant clinical or laboratory change that, at the opinion Investigator's opinion make the subject unsuitable for trial participation.
- Subjects with depression undergoing drug treatment or subjects with severe depression.
- Subjects with a history of angioedema.
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- Subjects with a previous diagnosis of class III or IV heart failure according to the New York Heart Association criteria.
- History of seizures.
- Recent (<6 months) myocardial infarction.
- Patients with increased intraocular pressure or who are at risk of closed-angle glaucoma.
- Subjects at risk of suicide at the Investigator's discretion.
- Prior treatment with chemotherapeutic agents that cause neuropathy, such as, but not limited to: platinum compounds (oxaliplatin, cisplatin and carboplatin) and taxanes (docetaxel and paclitaxel).
- History of current alcohol or drug abuse or dependence.
- Lack of response to prior treatment with pregabalin at doses ≥ 300 mg and/or duloxetine 60 mg.
- Use of prohibited medications within 7 days prior to the Screening Visit or change in concomitant drugs within 30 days prior to the Screening Visit.
- Use of prohibited concomitant medications that cannot be discontinued during participation in the clinical trial.
- Subjects with any clinically significant condition, including serious psychiatric disorders, which at the Investigator's discretion make the subject unsuitable for trial participation.
- History of any malignancy within the past 5 years, except successfully treated non-metastatic basal cell or squamous cell carcinoma of the skin.
- Subjects who have participated in other clinical trials in the last 12 months, unless the investigator believes there may be a direct benefit to them.
- Pregnant or breastfeeding female subjects or women of childbearing potential who do not agree to use contraception during the clinical trial.
- Glycated hemoglobin ≥ 10.5%.
- Subjects with severe renal impairment (estimated glomerular filtration rate based on creatinine by the CKD-EPI equation < 30 mL/min) and/or with severe liver disease (Aspartate Aminotransferase and Alanine Aminotransferase twice the reference value).
- Clinically significant cardiac arrhythmias, second- or third-degree heart block, or left bundle branch block on 12-lead electrocardiogram (ECG).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Prospective, Adaptive, Randomized, Double-blind, Triple-masked, Parallel, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the N0750 Compared to Monotherapies in the Treatment of Painful Diabetic Peripheral Neuropathy
A phase 3, prospective, adaptive, randomized, multicenter, double-blind, triple-masked, parallel clinical trial to evaluate the efficacy and safety of N0750 in relieving pain associated with painful diabetic peripheral neuropathy (PDPN).
Read the detailed description
The objective of this clinical trial is to demonstrate the superiority of treatment with N0750 compared to monotherapy with Cymbalta® (duloxetine hydrochloride 60 mg, delayed-release capsule) and Lyrica® (pregabalin 150 mg, hard capsule, given twice daily for a total daily dose of 300 mg).
The clinical trial population will consist of patients of both sexes, diagnosed with PDPN for at least 3 months, confirmed by the presence of signs and symptoms in the Neuropathic Impairment Score (NIS) and Neuropathic Symptom Score (NSS), respectively, and with pain ≥ 6 points on the Numerical Scale (11 points [0-10]).
The primary objective of this clinical trial is to evaluate the reduction in pain intensity associated with Diabetic Peripheral Neuropathy (DPN). The primary endpoint of the trial is the change from baseline (Randomisation Visit [RV]) at the end of 12 weeks of treatment (Visit 4) in the weekly mean pain intensity in the last 24 hours, as assessed by the Numerical Rating Scale (11 points [0-10]).
- Being tested
- N0750, Cymbalta®, Lyrica®
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes, Diabetes, Type 1, Diabetes, Type 2, Pain, diabetics, peripheral diabetic neuropathy, diabetic neuropathy peripheral, diabetic peripheral neuropathy, peripheral neuropathy, Peripheral Nervous System Diseases, peripheral, peripheral neuropathies, Peripheral nerve damage, neuropathies, neuropathy, PDPN
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Pain, Peripheral Nervous System Diseases, Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N0750Drug
N0750 caps + Cymbalta placebo caps + Lyrica placebo caps
Cymbalta®Drug
Cymbalta® caps + N0750 placebo caps + Lyrica placebo caps
Lyrica®Drug
Lyrica® caps + N0750 placebo caps + Cymbalta placebo caps
| Study group | Role | What they receive |
|---|---|---|
| N0750 | Experimental | * Phase 1 of the Dosage Titration: 3 capsules/day
* Phase 2 of the Dosage Titration: 5 capsules/day
* Treatment: 4 capsules/day
* Withdrawal: 4 capsules/day Receives: Drug: N0750 |
| Cymbalta® | Active comparator | * Phase 1 of the Dosage Titration: 3 capsules/day
* Phase 2 of the Dosage Titration: 5 capsules/day
* Treatment: 4 capsules/day
* Withdrawal: 4 capsules/day Receives: Drug: Cymbalta® |
| Lyrica® | Active comparator | * Phase 1 of the Dosage Titration: 3 capsules/day
* Phase 2 of the Dosage Titration: 5 capsules/day
* Treatment: 4 capsules/day
* Withdrawal: 4 capsules/day Receives: Drug: Lyrica® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of N0750 compared to Cymbalta® and Lyrica® in reducing pain intensity in patients with painful diabetic peripheral neuropathy
Change from baseline at the end of 12 weeks of treatment in the weekly average pain intensity in the last 24 hours using Numerical Rating Scale (11 points [0-10]), where higher scores mean a worse outcome.
Measured: 84 days
Secondary outcomes (3)
Evaluation of the efficacy of N0750 compared to Cymbalta® and Lyrica® in reducing pain in patients with painful diabetic peripheral neuropathy
Change from baseline (VR) at each week of treatment (week 1 to week 12) in the weekly average pain intensity in the last 24 hours by the Numerical Rating Scale (11 points [0-10]).
Proportion of subjects showing pain reduction ≥ 30% at the end of 12 weeks of treatment (V4) compared to baseline (VR).
Proportion of subjects showing pain reduction ≥ 50% at the end of 12 weeks of treatment (V4) compared to baseline (VR).
Measured: 84 days
Evaluation of the efficacy of N0750 compared to Cymbalta® and Lyrica® on subject perception of overall change in painful diabetic peripheral neuropathy
Change from baseline at the end of 12 weeks of treatment on the Patient Global Impression of Change questionnaire - PGIC-C (8 points [0-7]), where higher scores mean a better outcome.
Measured: 84 days
Evaluate the safety profile of N0750 compared to Cymbalta® and Lyrica®
Frequency and intensity of AEs (Adverse Event), TEAEs (Treatment Emergent Adverse Event), SAEs (Serious adverse event). All safety analyses will be based on all subjects who received at least one dose of the trial treatments.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study startApr 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Why it stopped: Strategic change in development priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic Peripheral Neuropathy (PDPN)Studies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715462
- Sponsor's protocol ID
- EF188
- Acronym
- ENFORCE
- Status last verified
- Feb 2025
- First submitted
- 26 Nov 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Prospective, Adaptive, Randomized, Double-blind, Triple-masked, Parallel, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the N0750 Compared to Monotherapies in the Treatment of Painful Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06715462
- Acronym / sponsor ID
- ENFORCE / EF188
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes, Diabetes, Type 1, Diabetes, Type 2, Pain, diabetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic change in development priorities
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 4 Dec 2024 (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.
A phase 3, prospective, adaptive, randomized, multicenter, double-blind, triple-masked, parallel clinical trial to evaluate the efficacy and safety of N0750 in relieving pain associated with painful diabetic peripheral neuropathy (PDPN).
Detailed description
The objective of this clinical trial is to demonstrate the superiority of treatment with N0750 compared to monotherapy with Cymbalta® (duloxetine hydrochloride 60 mg, delayed-release capsule) and Lyrica® (pregabalin 150 mg, hard capsule, given twice daily for a total daily dose of 300 mg).
The clinical trial population will consist of patients of both sexes, diagnosed with PDPN for at least 3 months, confirmed by the presence of signs and symptoms in the Neuropathic Impairment Score (NIS) and Neuropathic Symptom Score (NSS), respectively, and with pain ≥ 6 points on the Numerical Scale (11 points [0-10]).
The primary objective of this clinical trial is to evaluate the reduction in pain intensity associated with Diabetic Peripheral Neuropathy (DPN). The primary endpoint of the trial is the change from baseline (Randomisation Visit [RV]) at the end of 12 weeks of treatment (Visit 4) in the weekly mean pain intensity in the last 24 hours, as assessed by the Numerical Rating Scale (11 points [0-10]).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| N0750 | Experimental | Drug: N0750* Phase 1 of the Dosage Titration: 3 capsules/day * Phase 2 of the Dosage Titration: 5 capsules/day * Treatment: 4 capsules/day * Withdrawal: 4 capsules/day |
| Cymbalta® | Active comparator | Drug: Cymbalta®* Phase 1 of the Dosage Titration: 3 capsules/day * Phase 2 of the Dosage Titration: 5 capsules/day * Treatment: 4 capsules/day * Withdrawal: 4 capsules/day |
| Lyrica® | Active comparator | Drug: Lyrica®* Phase 1 of the Dosage Titration: 3 capsules/day * Phase 2 of the Dosage Titration: 5 capsules/day * Treatment: 4 capsules/day * Withdrawal: 4 capsules/day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to confirm voluntary participation and agree to all purposes of the trial, by signing and dating the Informed Consent Form (ICF) in two copies.
- Subjects of both sexes, aged between 18 and 80 years.
- Previous diagnosis of type 1 diabetes mellitus or type 2 diabetes mellitus.
- Subjects diagnosed with PDPN for at least 3 months, confirmed by NSS ≥ 5 points and NIS ≥ 3 points.
- Subjects who agree to discontinue current PDPN treatment during the washout period.
Key exclusion criteria (23 listed)
- Painful peripheral neuropathy due to other causes, e.g. B12 and/or folate deficiency and hypothyroidism.
- Previous diagnosis of other types of pain not related to PDPN, which at the Investigator's discretion, may confound the assessment of clinical trial endpoints, such as, but not limited to: peripheral vascular disease (ischemic pain); neurological disorders unrelated to diabetic neuropathy (phantom pain due to limb amputation); other painful conditions (e.g., arthritis).
- Skin changes in the PDPN area that may cause changes in sensitivity or preclude physical assessment, e.g.: plantar ulcer.
- Subjects with any other clinically significant clinical or laboratory change that, at the opinion Investigator's opinion make the subject unsuitable for trial participation.
- Subjects with depression undergoing drug treatment or subjects with severe depression.
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 |
|---|---|---|
| N0750N0750 caps + Cymbalta placebo caps + Lyrica placebo caps | Drug | N0750 |
| Cymbalta®Cymbalta® caps + N0750 placebo caps + Lyrica placebo caps | Drug | Cymbalta® |
| Lyrica®Lyrica® caps + N0750 placebo caps + Cymbalta placebo caps | Drug | Lyrica® |
Primary outcome
Evaluation of the efficacy of N0750 compared to Cymbalta® and Lyrica® in reducing pain intensity in patients with painful diabetic peripheral neuropathy
Time frame: 84 days
Change from baseline at the end of 12 weeks of treatment in the weekly average pain intensity in the last 24 hours using Numerical Rating Scale (11 points [0-10]), where higher scores mean a worse outcome.
3 secondary outcomes
Evaluation of the efficacy of N0750 compared to Cymbalta® and Lyrica® in reducing pain in patients with painful diabetic peripheral neuropathy
Time frame: 84 days
Evaluation of the efficacy of N0750 compared to Cymbalta® and Lyrica® on subject perception of overall change in painful diabetic peripheral neuropathy
Time frame: 84 days
Evaluate the safety profile of N0750 compared to Cymbalta® and Lyrica®
Time frame: 84 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 N0750, Cymbalta® and Lyrica® in people with Painful Diabetic Peripheral Neuropathy (PDPN), run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
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 23 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: withdrawn, as of the sponsor's last update on 18 Dec 2025. 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 Brazil. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Evaluation of the efficacy of N0750 compared to Cymbalta® and Lyrica® in reducing pain intensity in patients with painful diabetic peripheral neuropathy (time frame: 84 days). 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 18 Dec 2025.