# Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain

> **NCT01081912** · PHASE3 · COMPLETED · sponsor: **Zogenix, Inc.** · enrollment: 510 (actual)

## Conditions studied

- Back Pain Lower Back Chronic

## Interventions

- **DRUG:** Placebo
- **DRUG:** Hydrocodone bitartrate

## Key facts

- **NCT ID:** NCT01081912
- **Lead sponsor:** Zogenix, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2010-03
- **Primary completion:** 2011-10
- **Final completion:** 2011-10
- **Target enrollment:** 510 (ACTUAL)
- **Last updated:** 2022-12-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01081912

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01081912, "Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT01081912. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*