Efficacy and Safety of the N0750 Compared to Monotherapies in the Treatment of Painful Diabetic P… (NCT06715462) | Clinical Trial Compass
WithdrawnPhase 3
Efficacy and Safety of the N0750 Compared to Monotherapies in the Treatment of Painful Diabetic Peripheral Neuropathy
Stopped: Strategic change in development priorities
Brazil0Started 2026-04
Plain-language 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).
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Evaluation of the efficacy of N0750 compared to Cymbalta® and Lyrica® in reducing pain intensity in patients with painful diabetic peripheral neuropathy