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NCT01041859 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy, Safety, and Tolerability of Tapentadol ER Compared With Placebo in Patients With Chronic, Painful Diabetic Peripheral Neuropathy

A Phase 3 study of Diabetic Peripheral Neuropathy, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed
Registry status
Phase 3
Development phase
460
Enrollment target
20
Study locations

NCT01041859 is a Phase 3 study of Diabetic Peripheral Neuropathy that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 460 participants, above the 101-participant average among 17 other Diabetic Peripheral Neuropathy trials with a reported enrollment target (355% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT01041859, a Phase 3 study of Diabetic Peripheral Neuropathy, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

COMPLETED
Registry status
Phase 3
Development phase
460 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of orally administered tapentadol extended release (ER) at dosages of 100 to 250 mg twice daily compared with placebo in patients with moderate to severe pain due to chronic, painful diabetic peripheral neuropathy (DPN) who tolerated tapentadol (ER) and have an initial treatment effect (pain improvement) after a 3-week, open-label titration period.

Conditions Studied

Diabetic Peripheral Neuropathy

Interventions

  • DRUG Placebo
  • DRUG Tapentadol extended release (ER)

Study Locations (20)

California

  • - Fresno
  • - Orange
  • - Redding
  • - Sacramento
  • - San Francisco
  • - Spring Valley
  • - Walnut Creek

Florida

  • - Clearwater
  • - Hallandale
  • - Miami
  • - Ormond Beach
  • - St. Petersburg
  • - Tampa
  • - West Palm Beach

Arizona

  • - Chandler
  • - Mesa
  • - Phoenix

Alabama

  • - Mobile

Colorado

  • - Denver

Georgia

  • - Atlanta

Trial Details

FieldValue
Enrollment Target 460 participants
Start Date 2009-12
Est. Completion 2011-03
Phase Phase 3

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

102 total trials

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What the Registry Record Tells You About NCT01041859

The ClinicalTrials.gov registry entry for NCT01041859 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 460 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 101-participant average among 17 other Diabetic Peripheral Neuropathy trials with a reported enrollment target (355% higher). The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 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 2 interventions - of which Placebo is the first listed.

NCT01041859 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT01041859 about?

NCT01041859 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, and Tolerability of Tapentadol ER Compared With Placebo in Patients With Chronic, Painful Diabetic Peripheral Neuropathy". The purpose of this study is to evaluate the efficacy, safety, and tolerability of orally administered tapentadol extended release (ER) at dosages of 100 to 250 mg twice daily compared with placebo in patients with moderate to severe pain due to chronic, painful diabetic peripheral neuropathy (DPN) ...

What is the current status of trial NCT01041859?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 460 participants. The study started on 2009-12. Estimated completion is 2011-03.

What conditions does trial NCT01041859 study?

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

What interventions are being tested in trial NCT01041859?

The interventions under investigation include: Placebo (DRUG), Tapentadol extended release (ER) (DRUG).

Who is sponsoring clinical trial NCT01041859?

This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01041859 being conducted?

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.