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NCT04455633 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety, and PK of LX9211 in Participants With Diabetic Peripheral Neuropathic Pain
A Phase 2 study of Diabetes and Diabetic Peripheral Neuropathy, sponsored by Lexicon Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 319
- Enrollment target
- 20
- Study locations
NCT04455633: Completed Phase 2 study of Diabetes and Diabetic Peripheral Neuropathy, sponsored by Lexicon Pharmaceuticals.
NCT04455633 is a Phase 2 study of Diabetes and Diabetic Peripheral Neuropathy that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 319 participants, below the 3,027-participant average among 338 other Diabetes trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04455633, a Phase 2 study of Diabetes and Diabetic Peripheral Neuropathy, has completed, sponsored by Lexicon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 319 participants
- Enrollment target
- 20
- Study locations
Study Summary
Evaluation of the efficacy of a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy (DPNP) over an 11 week assessment period.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG LX9211
- DRUG LX9211 Matching Placebo
Study Locations (20)
Florida
- Lexicon Investigational Site - Brandon
- Lexicon Investigational Site - Fort Myers
- Lexicon Investigational Site - Jacksonville
- Lexicon Investigational Site - Lake City
- Lexicon Investigational Site - New Port Richey
- Lexicon Investigational Site - Ormond Beach
- Lexicon Investigational Site - Winter Park
California
- Lexicon Investigational Site - Anaheim
- Lexicon Investigational Site - Greenbrae
- Lexicon Investigational Site - Los Angeles
- Lexicon Investigational Site - North Hollywood
- Lexicon Investigational Site - Sacramento
- Lexicon Investigational Site - Tustin
Arizona
- Lexicon Investigational Site - Chandler
- Lexicon Investigational Site - Glendale
- Lexicon Investigational Site - Kingman
- Lexicon Investigational Site - Tucson
Alabama
- Lexicon Investigational Site - Mobile
Georgia
- Lexicon Investigational Site - Macon
Indiana
- Lexicon Investigational Site - Evansville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 319 participants |
| Start Date | 2020-09-03 |
| Est. Completion | 2022-06-28 |
| Phase | Phase 2 |
What the finished NCT04455633 record still lists
NCT04455633 is an interventional study that assigns participants to a tested intervention. The registered 319 participants enrollment target is mid-sized for trials with a published cap, below the 3,027-participant average among 338 other Diabetes trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 2 interventions - of which LX9211 is the first listed.
NCT04455633 names 20 study sites across 6 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04455633 about?
NCT04455633 is a clinical study titled "Efficacy, Safety, and PK of LX9211 in Participants With Diabetic Peripheral Neuropathic Pain". Evaluation of the efficacy of a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy (DPNP) over an 11 week assessment period.
What is the current status of trial NCT04455633?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 319 participants. The study started on 2020-09-03. Estimated completion is 2022-06-28.
What conditions does trial NCT04455633 study?
This clinical trial studies the following conditions: Diabetes, Diabetic Peripheral Neuropathy.
What interventions are being tested in trial NCT04455633?
The interventions under investigation include: LX9211 (DRUG), LX9211 Matching Placebo (DRUG).
Who is sponsoring clinical trial NCT04455633?
This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04455633 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04455633's enrollment target sits among peer trials
319 107th of 338 higher than 232 of 338 other Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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