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

> **NCT01789970** · PHASE3 · COMPLETED · sponsor: **Teva Branded Pharmaceutical Products R&D, Inc.** · enrollment: 625 (actual)

## Conditions studied

- Low Back Pain

## Interventions

- **DRUG:** Hydrocodone ER
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT01789970
- **Lead sponsor:** Teva Branded Pharmaceutical Products R&D, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2013-03
- **Primary completion:** 2014-02
- **Final completion:** 2014-02
- **Target enrollment:** 625 (ACTUAL)
- **Last updated:** 2017-06-05


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01789970

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01789970, "Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT01789970. Licensed CC0.

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