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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 is a Phase 3 study that has completed, run by Purdue Pharma. The registered enrollment target is 905 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01452529
The ClinicalTrials.gov registry entry for NCT01452529 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 905 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Purdue Pharma, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Hydrocodone bitartrate q24h film-coated tablets is the first listed.
NCT01452529 reports 0 study locations.
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.
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