Evaluation of the efficacy of LX9211 compared to placebo in reducing DPNP. Please see study website: https://diabeticpainstudy.com/
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
496
LX9211 matching placebo tablets
LX9211 (blinded) tablets
Change from Baseline to Week 8 in Average Daily Pain Score (ADPS)
ADPS is based on the 11-point numerical rating scale (NRS) \[0 (no pain) to 10 (worst imaginable pain)\].
Time frame: Baseline, Week 8
Change from Baseline to Week 8 in Burning Pain
Burning pain is based on the 11-point NRS (0 \[no burning\] to 10 \[worst burning imaginable\]).
Time frame: Baseline, Week 8
Change from Baseline to Week 8 in Pain Interference on Sleep
Pain interference on sleep is based on the 11-point NRS (0 \[does not interfere\] to 10 \[completely interferes\]).
Time frame: Baseline, Week 8
Patient Global Impression of Change (PGIC) Score at Week 8
The PGIC is a 7-point rating scale that assesses a participant's belief about the overall improvement experienced by the participant where 1=very much improved and 7=very much worse.
Time frame: Week 8
Change from Baseline to Week 8 in Total Neuropathic Pain Symptom Inventory (NPSI) Score
NPSI total score is based on 5 subscales evaluating different symptoms of neuropathic pain, each evaluated on a scale of 0 (no pain) to 10 (worst pain). The total score ranges from 0 to 100. A higher score indicates a worse outcome.
Time frame: Baseline, Week 8
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