Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT04455633
Eligibility Criteria:
Inclusion Criteria:
* Participant has given written informed consent to participate in the study in accordance with local regulations
* Adult male and female participants ≥18 years of age at the time of screening
* Body mass index ≥18.0 to ≤40.0 kg/m2 at Screening
* Diagnosis of diabetic peripheral neuropathic pain (DPNP) at Screening
* Pain from DPN present for at least 6 months
* Haemoglobin A1C ≤11% at screening
* Stable regimen for the treatment of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) for ≥1 month prior to Screening
Exclusion Criteria:
* Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
* History of major depressive episode, active, significant psychiatric disorders
* History of clinically significant drug or alcohol use disorder
* History of neurolytic or neurosurgical therapy for DPNP
* Use of opioid medications for management of DPNP within the 2 months prior to Screening Visit
* Use of non-steroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to the Screening Visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04455633
Study Brief:
Protocol Section:
NCT04455633