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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 is a Phase 3 study that has completed, run by Esteve Pharmaceuticals, S.A.. The registered enrollment target is 637 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03108482
The ClinicalTrials.gov registry entry for NCT03108482 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 637 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Esteve Pharmaceuticals, S.A., which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03108482 reports 0 study locations.
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.
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