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NCT00195728 · ClinicalTrials.gov registry record · Phase 3
Long Term Safety and Tolerability Study in Approximately 350 Subjects With Moderate to Severe Chronic, Non-malignant Pain
A Phase 3 study, sponsored by Abbott.
- Completed
- Registry status
- Phase 3
- Development phase
- 431
- Enrollment target
NCT00195728: Completed Phase 3 study, sponsored by Abbott.
NCT00195728 is a Phase 3 study that has completed, run by Abbott. The registered enrollment target is 431 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00195728, a Phase 3 study, has completed, sponsored by Abbott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 431 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety of Vicodin CR (combination opioid and acetaminophen containing product) in patients with chronic pain due to osteoarthritis or low back pain.
Primary Outcome
Long term safety
Interventions
- DRUG Hydrocodone/Acetaminophen on Extended Release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 431 participants |
| Start Date | 2005-06 |
| Est. Completion | 2006-12 |
| Phase | Phase 3 |
What the finished NCT00195728 record still lists
NCT00195728 is an interventional study that assigns participants to a tested intervention. The registered 431 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 1 intervention - of which Hydrocodone/Acetaminophen on Extended Release is the first listed.
NCT00195728 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00195728 about?
NCT00195728 is a clinical study titled "Long Term Safety and Tolerability Study in Approximately 350 Subjects With Moderate to Severe Chronic, Non-malignant Pain". The purpose of the study is to evaluate the safety of Vicodin CR (combination opioid and acetaminophen containing product) in patients with chronic pain due to osteoarthritis or low back pain.
What is the current status of trial NCT00195728?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 431 participants. The study started on 2005-06. Estimated completion is 2006-12.
What interventions are being tested in trial NCT00195728?
The interventions under investigation include: Hydrocodone/Acetaminophen on Extended Release (DRUG).
Who is sponsoring clinical trial NCT00195728?
This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00195728's enrollment target sits among peer trials
431 877th of 2000 higher than 1,124 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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