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NCT01496365 · ClinicalTrials.gov registry record · Phase 2

Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

A Phase 2 study of Diabetic Peripheral Neuropathy, sponsored by Daiichi Sankyo.

Completed
Registry status
Phase 2
Development phase
452
Enrollment target
20
Study locations

NCT01496365 is a Phase 2 study of Diabetic Peripheral Neuropathy that has completed, run by Daiichi Sankyo. The registered enrollment target is 452 participants, above the 102-participant average among 17 other Diabetic Peripheral Neuropathy trials with a reported enrollment target (343% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT01496365, a Phase 2 study of Diabetic Peripheral Neuropathy, has completed, sponsored by Daiichi Sankyo.

COMPLETED
Registry status
Phase 2
Development phase
452 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the safety, tolerability and effectiveness of DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with DPN.

Interventions

  • DRUG Placebo tablet
  • DRUG placebo capsule
  • DRUG DS-5565 tablet
  • DRUG pregabalin capsule

Study Locations (20)

California

  • - Buena Park
  • - Burbank
  • - Chino
  • - Fresno
  • - Huntington Beach
  • - Lakewood
  • - Lomita
  • - Long Beach
  • - Santa Monica
  • - Walnut Creek

Arizona

  • - Mesa
  • - Phoenix
  • - Phoenix
  • - Tucson

Alabama

  • - Birmingham
  • - Huntsville

Arkansas

  • - Hot Springs
  • - Little Rock

Colorado

  • - Boulder
  • - Colorado Springs

Trial Details

FieldValue
Enrollment Target 452 participants
Start Date 2011-11-28
Est. Completion 2012-09-07
Phase Phase 2

Sponsor

Daiichi Sankyo

236 total trials

What the Registry Record Tells You About NCT01496365

The ClinicalTrials.gov registry entry for NCT01496365 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 452 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 102-participant average among 17 other Diabetic Peripheral Neuropathy trials with a reported enrollment target (343% higher). The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetic Peripheral Neuropathy appearing as the primary indexed condition, and to 4 interventions - of which Placebo tablet is the first listed.

NCT01496365 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT01496365 about?

NCT01496365 is a clinical study titled "Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy". The purpose of this study is to evaluate the safety, tolerability and effectiveness of DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with DPN.

What is the current status of trial NCT01496365?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 452 participants. The study started on 2011-11-28. Estimated completion is 2012-09-07.

What conditions does trial NCT01496365 study?

This clinical trial studies the following conditions: Diabetic Peripheral Neuropathy.

What interventions are being tested in trial NCT01496365?

The interventions under investigation include: Placebo tablet (DRUG), placebo capsule (DRUG), DS-5565 tablet (DRUG), pregabalin capsule (DRUG).

Who is sponsoring clinical trial NCT01496365?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01496365 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. 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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