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NCT04191031 · ClinicalTrials.gov registry record · NA
Study to Evaluate Iovera®° in Adult Patients Undergoing Total Knee Arthroplasty
A NA study, sponsored by Pacira Pharmaceuticals.
- Terminated
- Registry status
- NA
- Development phase
- 79
- Enrollment target
NCT04191031 is a NA study that was terminated before completion, run by Pacira Pharmaceuticals. The registered enrollment target is 79 participants.
The verdict
NCT04191031, a NA study, was terminated before completion, sponsored by Pacira Pharmaceuticals.
- TERMINATED
- Registry status
- NA
- Development phase
- 79 participants
- Enrollment target
Study Summary
Primary objective: The primary objective of this study is to evaluate postsurgical pain control, after presurgical iovera° treatment plus EXPAREL® and standardized multimodal therapy compared with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy in subjects undergoing primary unilateral total knee arthroplasty (TKA). Secondary objectives: The secondary objectives of this study are to compare postsurgical pain control or postsurgical total opioid consumption, opioid-free status, physical function, sleep quality, and safety of presurgical iovera° treatment plus EXPAREL and standardized multimodal therapy with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy, in subjects undergoing primary unilateral TKA
Interventions
- DEVICE ioveraº
- DEVICE ioveraº sham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2020-09-30 |
| Est. Completion | 2022-07-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04191031
The ClinicalTrials.gov registry entry for NCT04191031 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pacira Pharmaceuticals, which has 88 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ioveraº is the first listed.
NCT04191031 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04191031 about?
NCT04191031 is a clinical study titled "Study to Evaluate Iovera®° in Adult Patients Undergoing Total Knee Arthroplasty". Primary objective: The primary objective of this study is to evaluate postsurgical pain control, after presurgical iovera° treatment plus EXPAREL® and standardized multimodal therapy compared with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy in subjects undergo...
What is the current status of trial NCT04191031?
This trial is currently terminated. It is a NA study. The enrollment target is 79 participants. The study started on 2020-09-30. Estimated completion is 2022-07-12.
What interventions are being tested in trial NCT04191031?
The interventions under investigation include: ioveraº (DEVICE), ioveraº sham (DEVICE).
Who is sponsoring clinical trial NCT04191031?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
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