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NCT01928849 · ClinicalTrials.gov registry record · Phase 2
Valproic Acid for the Prevention of Post-Amputation Pain
A Phase 2 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 128
- Enrollment target
NCT01928849 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 128 participants.
The verdict
NCT01928849, a Phase 2 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 128 participants
- Enrollment target
Study Summary
The objectives of this study are, to test the effectiveness of Valproic Acid (VPA) in the prevention of chronic neuropathic and post-amputation pain, as well as to further define the underlying inflammatory and epigenetic mechanisms that lead to the development of such chronic pain. HYPOTHESES AND QUESTIONS Hypothesis 1: The use of oral valproic acid in combination with regional anesthesia in surgical limb-injury patients will decrease the incidence of chronic nerve injury and post-amputation pain. Goal 1: In a blinded, randomized placebo-controlled, multi-center clinical trial, investigators will determine if oral VPA added to regional anesthesia and standard perioperative management will reduce the incidence of nerve injury and post-amputation pain when compared with regional anesthesia alone. Hypothesis 2: The transition from acute to chronic pain is mediated via epigenetic mechanisms (differential DNA methylation) in genes involved in nociception. Goal 2: Investigators will analyze the DNA methylation patterns of patients with different types of neuropathic and post-amputation pain and determine if they are altered by VPA.
Interventions
- DRUG Valproic Acid
- OTHER Cherry Syrup
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2013-12 |
| Est. Completion | 2017-09-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01928849
The ClinicalTrials.gov registry entry for NCT01928849 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Valproic Acid is the first listed.
NCT01928849 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01928849 about?
NCT01928849 is a clinical study titled "Valproic Acid for the Prevention of Post-Amputation Pain". The objectives of this study are, to test the effectiveness of Valproic Acid (VPA) in the prevention of chronic neuropathic and post-amputation pain, as well as to further define the underlying inflammatory and epigenetic mechanisms that lead to the development of such chronic pain. HYPOTHESES AND ...
What is the current status of trial NCT01928849?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 128 participants. The study started on 2013-12. Estimated completion is 2017-09-26.
What interventions are being tested in trial NCT01928849?
The interventions under investigation include: Valproic Acid (DRUG), Cherry Syrup (OTHER).
Who is sponsoring clinical trial NCT01928849?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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