Efficacy, Safety, and PK of LX9211 in Patients With Diabetic Peripheral Neuropathic Pain
Sponsored by Lexicon Pharmaceuticals
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 3 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Patient has given written informed consent to participate in the study in accordance with local regulations
- Adult male and female patients ≥18 years of age at the time of screening
- Body mass index ≥18.0 to ≤40.0 kg/m2 at Screening
- Diagnosis of DPNP at Screening
- Pain from DPN present for at least 6 months
- A1C ≤11% at screening
- Stable regimen for the treatment of T1DM or 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 NSAIDs less than 2 weeks prior to the Screening Visit