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NCT01755546 · ClinicalTrials.gov registry record · Phase 3
Long-term Open-Label Safety Study to Evaluate EN3409
A Phase 3 study, sponsored by BioDelivery Sciences International.
- Completed
- Registry status
- Phase 3
- Development phase
- 304
- Enrollment target
NCT01755546: Completed Phase 3 study, sponsored by BioDelivery Sciences International.
NCT01755546 is a Phase 3 study that has completed, run by BioDelivery Sciences International. The registered enrollment target is 304 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01755546, a Phase 3 study, has completed, sponsored by BioDelivery Sciences International.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 304 participants
- Enrollment target
Study Summary
The purpose of the long-terms study is to evaluate the safety, tolerability, and analgesic efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time.
Primary Outcome
The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and the change from baseline at week 48 is presented.
Interventions
- DRUG EN3409
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2012-12 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
What the finished NCT01755546 record still lists
NCT01755546 is an interventional study that assigns participants to a tested intervention. The registered 304 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 (61% lower).
The record links to 0 conditions, and to 1 intervention - of which EN3409 is the first listed.
NCT01755546 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01755546 about?
NCT01755546 is a clinical study titled "Long-term Open-Label Safety Study to Evaluate EN3409". The purpose of the long-terms study is to evaluate the safety, tolerability, and analgesic efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time.
What is the current status of trial NCT01755546?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 304 participants. The study started on 2012-12. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01755546?
The interventions under investigation include: EN3409 (DRUG).
Who is sponsoring clinical trial NCT01755546?
This trial is sponsored by BioDelivery Sciences International, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01755546's enrollment target sits among peer trials
304 1117th of 2000 higher than 882 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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