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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 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.

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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.

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

FieldValue
Enrollment Target 319 participants
Start Date 2020-09-03
Est. Completion 2022-06-28
Phase Phase 2

Sponsor

Lexicon Pharmaceuticals

56 total trials

What the Registry Record Tells You About NCT04455633

The ClinicalTrials.gov registry entry for NCT04455633 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 319 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,027-participant average among 338 other Diabetes trials with a reported enrollment target (89% lower). The listed sponsor is Lexicon Pharmaceuticals, which has 56 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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