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NCT01922739 · ClinicalTrials.gov registry record · Phase 3
Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 182
- Enrollment target
NCT01922739 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 182 participants.
The verdict
NCT01922739, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 182 participants
- Enrollment target
Study Summary
This is a 6-month, nonrandomized, open-label extension study to assess the long-term safety of hydrocodone bitartrate extended-release (ER) tablets in patients with moderate to severe chronic low back pain who require continuous opioid treatment for an extended period of time. To be eligible for Study 3104, patients were required to have completed the entire double blind treatment period on study drug (either placebo or hydrocodone bitartrate ER tablets) through week 12 of Study 3103 (NCT01789970) and to have met the entry criteria for Study 3104.
Interventions
- DRUG Placebo
- DRUG Hydrocodone ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01922739
The ClinicalTrials.gov registry entry for NCT01922739 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 182 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 167 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01922739 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01922739 about?
NCT01922739 is a clinical study titled "Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets". This is a 6-month, nonrandomized, open-label extension study to assess the long-term safety of hydrocodone bitartrate extended-release (ER) tablets in patients with moderate to severe chronic low back pain who require continuous opioid treatment for an extended period of time. To be eligible for St...
What is the current status of trial NCT01922739?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 182 participants. The study started on 2013-07. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01922739?
The interventions under investigation include: Placebo (DRUG), Hydrocodone ER (DRUG).
Who is sponsoring clinical trial NCT01922739?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
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