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NCT01364922 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Chronic Low Back Pain Study
A Phase 2 study, sponsored by AbbVie (prior sponsor, Abbott).
- Completed
- Registry status
- Phase 2
- Development phase
- 168
- Enrollment target
NCT01364922: Completed Phase 2 study, sponsored by AbbVie (prior sponsor, Abbott).
NCT01364922 is a Phase 2 study that has completed, run by AbbVie (prior sponsor, Abbott). The registered enrollment target is 168 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01364922, a Phase 2 study, has completed, sponsored by AbbVie (prior sponsor, Abbott).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 168 participants
- Enrollment target
Study Summary
The primary purpose of this study was to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo.
Primary Outcome
The change from the double-blind randomization baseline (DB baseline: the last assessment before first dose in the double-blind period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from an ANCOVA model.
Interventions
- DRUG Placebo
- DRUG hydrocodone/acetaminophen extended release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2011-06 |
| Est. Completion | 2011-10 |
| Phase | Phase 2 |
What the finished NCT01364922 record still lists
NCT01364922 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01364922 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01364922 about?
NCT01364922 is a clinical study titled "Phase 2 Chronic Low Back Pain Study". The primary purpose of this study was to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo.
What is the current status of trial NCT01364922?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 168 participants. The study started on 2011-06. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01364922?
The interventions under investigation include: Placebo (DRUG), hydrocodone/acetaminophen extended release (DRUG).
Who is sponsoring clinical trial NCT01364922?
This trial is sponsored by AbbVie (prior sponsor, Abbott), which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01364922's enrollment target sits among peer trials
168 403rd of 2000 higher than 1,595 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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