Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain
NCT01789970 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 625 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 625 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 103 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01789970 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01789970?
The interventions under investigation include: Placebo (DRUG), Hydrocodone ER (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01789970?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 103 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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