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NCT02541396 · ClinicalTrials.gov registry record · Phase 2
A Study Of The Effectiveness Of Wafermine Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy
A Phase 2 study, sponsored by iX Biopharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
NCT02541396: Completed Phase 2 study, sponsored by iX Biopharma.
NCT02541396 is a Phase 2 study that has completed, run by iX Biopharma. The registered enrollment target is 72 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02541396, a Phase 2 study, has completed, sponsored by iX Biopharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
Study Summary
To evaluate the safety and effectiveness of Wafermine administered with and without an opioid medication for acute pain following bunionectomy surgery.
Primary Outcome
Subjects will use an 11 point numerical pain rating scale (NPRS) where 0=No Pain and 10= Worst Possible pain to rate their pain at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5, 16 and 24 hours. TOTPAR is computed as follows at the specified time points: TOTPAR-t = ∑ \[T(i) - T(i-1) \* \[(PR(i-1) + PR(i))/2\]
Interventions
- DRUG Placebo
- DRUG Oxycodone
- DRUG Wafermine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2015-10 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
What the finished NCT02541396 record still lists
NCT02541396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02541396 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02541396 about?
NCT02541396 is a clinical study titled "A Study Of The Effectiveness Of Wafermine Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy". To evaluate the safety and effectiveness of Wafermine administered with and without an opioid medication for acute pain following bunionectomy surgery.
What is the current status of trial NCT02541396?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2015-10. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02541396?
The interventions under investigation include: Placebo (DRUG), Oxycodone (DRUG), Wafermine (DRUG).
Who is sponsoring clinical trial NCT02541396?
This trial is sponsored by iX Biopharma, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02541396's enrollment target sits among peer trials
72 925th of 2000 higher than 1,065 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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