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NCT03108482 · ClinicalTrials.gov registry record · Phase 3
Co-crystal E-58425 vs Tramadol and Celecoxib for Moderate to Severe Acute Pain After Bunionectomy. Phase III Clinical Trial.
A Phase 3 study, sponsored by Esteve Pharmaceuticals, S.A..
- Completed
- Registry status
- Phase 3
- Development phase
- 637
- Enrollment target
NCT03108482: Completed Phase 3 study, sponsored by Esteve Pharmaceuticals, S.A..
NCT03108482 is a Phase 3 study that has completed, run by Esteve Pharmaceuticals, S.A.. The registered enrollment target is 637 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03108482, a Phase 3 study, has completed, sponsored by Esteve Pharmaceuticals, S.A..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 637 participants
- Enrollment target
Study Summary
This is a Phase 3, randomized, double-blind, controlled, parallel-group, multicenter clinical trial with co-crystal E-58425 compared to tramadol, to celecoxib, and to placebo. The primary objective of the trial is to establish the analgesic efficacy of co-crystal E-58425 by demonstrating a superior effect compared to tramadol and to celecoxib for the management of moderate to severe acute post-operative pain for 48 hours after bunionectomy.
Primary Outcome
The primary efficacy variable was the Pain Intensity (PI) measured by the Numerical Pain Rating Scale (NPRS); a scale from zero to 10 on which subjects circled a single number to indicate current pain level, with zero representing "No Pain" and 10 representing "Worst Possible Pain". The primary analysis endpoint was the Sum of Pain Intensity Differences (SPID) from 0 to 48 hours. Pain Intensity Differences (PID) was the difference between current PI at assessment minus baseline PI (prior to the
Interventions
- DRUG Placebo
- DRUG Co-crystal E-58425 (Tramadol/Celecoxib)
- DRUG Tramadol (Ultram®)
- DRUG Celecoxib (Celebrex®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 637 participants |
| Start Date | 2017-03-14 |
| Est. Completion | 2017-11-28 |
| Phase | Phase 3 |
What the finished NCT03108482 record still lists
NCT03108482 is an interventional study that assigns participants to a tested intervention. The registered 637 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 (17% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03108482 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03108482 about?
NCT03108482 is a clinical study titled "Co-crystal E-58425 vs Tramadol and Celecoxib for Moderate to Severe Acute Pain After Bunionectomy. Phase III Clinical Trial.". This is a Phase 3, randomized, double-blind, controlled, parallel-group, multicenter clinical trial with co-crystal E-58425 compared to tramadol, to celecoxib, and to placebo. The primary objective of the trial is to establish the analgesic efficacy of co-crystal E-58425 by demonstrating a superior ...
What is the current status of trial NCT03108482?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 637 participants. The study started on 2017-03-14. Estimated completion is 2017-11-28.
What interventions are being tested in trial NCT03108482?
The interventions under investigation include: Placebo (DRUG), Co-crystal E-58425 (Tramadol/Celecoxib) (DRUG), Tramadol (Ultram®) (DRUG), Celecoxib (Celebrex®) (DRUG).
Who is sponsoring clinical trial NCT03108482?
This trial is sponsored by Esteve Pharmaceuticals, S.A., which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03108482's enrollment target sits among peer trials
637 579th of 2000 higher than 1,422 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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