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NCT00415597 · ClinicalTrials.gov registry record · Phase 3
Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 467
- Enrollment target
NCT00415597: Completed Phase 3 study, sponsored by Pfizer.
NCT00415597 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 467 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00415597, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 467 participants
- Enrollment target
Study Summary
Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.
Primary Outcome
Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product).
Interventions
- DRUG ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 467 participants |
| Start Date | 2006-12 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
What the finished NCT00415597 record still lists
NCT00415597 is an interventional study that assigns participants to a tested intervention. The registered 467 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 (40% lower).
The record links to 0 conditions, and to 1 intervention - of which ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER) is the first listed.
NCT00415597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00415597 about?
NCT00415597 is a clinical study titled "Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain". Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.
What is the current status of trial NCT00415597?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 467 participants. The study started on 2006-12. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00415597?
The interventions under investigation include: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER) (DRUG).
Who is sponsoring clinical trial NCT00415597?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00415597's enrollment target sits among peer trials
467 816th of 2000 higher than 1,185 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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