NCT04455633Phase 2Completed

Efficacy, Safety, and PK of LX9211 in Participants With Diabetic Peripheral Neuropathic Pain

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2022-05-23Actual

Enrollment · participants319Actual

Source updated2025-06-25Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Diabetic Peripheral Neuropathy; Diabetes

Treatments or interventions studied

LX9211Drug
LX9211 Matching PlaceboDrug

Primary outcomes · main study measures

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measure: Change From Baseline to Week 6 in ADPS as Measured by the Numerical Rating Scale; description: ADPS is based on question 5 of Brief Pain Inventory (BPI)-short form for Diabetic Peripheral Neuropathy (BPI-DPN) and is assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Higher ADPS scores indicate higher pain intensity. Negative change from baseline indicates improvement.; timeFrame: Baseline (Week 2 of the Run-in period) to Week 6

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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