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NCT01452529 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain
A Phase 3 study, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 905
- Enrollment target
NCT01452529: Completed Phase 3 study, sponsored by Purdue Pharma.
NCT01452529 is a Phase 3 study that has completed, run by Purdue Pharma. The registered enrollment target is 905 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01452529, a Phase 3 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 905 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the analgesic efficacy and safety of HYD tablets 20 to 120 mg once-daily dose compared to placebo in subjects with moderate to severe chronic low back pain uncontrolled by their current stable analgesic regimen
Primary Outcome
Mean pain intensity for "average pain over the last 24 hours" score (on an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine).
Interventions
- DRUG Hydrocodone bitartrate q24h film-coated tablets
- DRUG Placebo to match hydrocodone bitartrate q24h tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 905 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
What the finished NCT01452529 record still lists
NCT01452529 is an interventional study that assigns participants to a tested intervention. The registered 905 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 2 interventions - of which Hydrocodone bitartrate q24h film-coated tablets is the first listed.
NCT01452529 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01452529 about?
NCT01452529 is a clinical study titled "Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain". The primary objective of this study is to evaluate the analgesic efficacy and safety of HYD tablets 20 to 120 mg once-daily dose compared to placebo in subjects with moderate to severe chronic low back pain uncontrolled by their current stable analgesic regimen
What is the current status of trial NCT01452529?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 905 participants. The study started on 2011-10. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01452529?
The interventions under investigation include: Hydrocodone bitartrate q24h film-coated tablets (DRUG), Placebo to match hydrocodone bitartrate q24h tablets (DRUG).
Who is sponsoring clinical trial NCT01452529?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01452529's enrollment target sits among peer trials
905 347th of 2000 higher than 1,653 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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