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NCT01789970 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain

A Phase 3 study of Low Back Pain, sponsored by Teva Branded Pharmaceutical Products R&D.

Completed
Registry status
Phase 3
Development phase
625
Enrollment target
20
Study locations

NCT01789970 is a Phase 3 study of Low Back Pain that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 625 participants, above the 499-participant average among 122 other Low Back Pain trials with a reported enrollment target (25% higher). The trial reports 20 study locations across 3 states.

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The verdict

NCT01789970, a Phase 3 study of Low Back Pain, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.

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

Study Summary

The primary objective of this study is to evaluate the efficacy of hydrocodone bitartrate extended-release tablets at doses of 30 to 90 mg every 12 hours compared with placebo in alleviating moderate to severe pain in patients with chronic low back pain. Patients may be opioid-naïve or opioid-experienced.

Conditions Studied

Low Back Pain

Interventions

  • DRUG Placebo
  • DRUG Hydrocodone ER

Study Locations (20)

California

  • Teva Investigational Site 10358 - Anaheim
  • Teva Investigational Site 10408 - Bell Gardens
  • Teva Investigational Site 10425 - Carmichael
  • Teva Investigational Site 10390 - Cerritos
  • Teva Investigational Site 10429 - El Cajon
  • Teva Investigational Site 10423 - Escondido
  • Teva Investigational Site 10740 - Garden Grove
  • Teva Investigational Site 10391 - Huntington Park
  • Teva Investigational Site 10422 - La Jolla
  • Teva Investigational Site 10413 - Laguna Hills
  • Teva Investigational Site 10442 - Laguna Hills

Alabama

  • Teva Investigational Site 10416 - Anniston
  • Teva Investigational Site 10382 - Birmingham
  • Teva Investigational Site 10403 - Birmingham
  • Teva Investigational Site 10412 - Birmingham
  • Teva Investigational Site 10426 - Mobile
  • Teva Investigational Site 10436 - Montgomery

Arizona

  • Teva Investigational Site 10363 - Phoenix
  • Teva Investigational Site 10366 - Phoenix
  • Teva Investigational Site 10437 - Tucson

Trial Details

FieldValue
Enrollment Target 625 participants
Start Date 2013-03
Est. Completion 2014-02
Phase Phase 3

Sponsor

Teva Branded Pharmaceutical Products R&D

167 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01789970

The ClinicalTrials.gov registry entry for NCT01789970 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 625 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 499-participant average among 122 other Low Back Pain trials with a reported enrollment target (25% higher). The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Low Back Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01789970 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Alabama, Arizona.

Frequently Asked Questions

What is clinical trial NCT01789970 about?

NCT01789970 is a clinical study titled "Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain". The primary objective of this study is to evaluate the efficacy of hydrocodone bitartrate extended-release tablets at doses of 30 to 90 mg every 12 hours compared with placebo in alleviating moderate to severe pain in patients with chronic low back pain. Patients may be opioid-naïve or opioid-experi...

What is the current status of trial NCT01789970?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 625 participants. The study started on 2013-03. Estimated completion is 2014-02.

What conditions does trial NCT01789970 study?

This clinical trial studies the following conditions: Low Back Pain.

What interventions are being tested in trial NCT01789970?

The interventions under investigation include: Placebo (DRUG), Hydrocodone ER (DRUG).

Who is sponsoring clinical trial NCT01789970?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01789970 being conducted?

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