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NCT03321955 · ClinicalTrials.gov registry record · Phase 4
Ziconotide as First-Line IDT
A Phase 4 study, sponsored by Albany Medical College.
- Completed
- Registry status
- Phase 4
- Development phase
- 13
- Enrollment target
NCT03321955 is a Phase 4 study that has completed, run by Albany Medical College. The registered enrollment target is 13 participants.
The verdict
NCT03321955, a Phase 4 study, has completed, sponsored by Albany Medical College.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 13 participants
- Enrollment target
Study Summary
The primary objective of this study is to prospectively examine outcomes in 12 patients using ziconotide Intrathecal Drug Therapy(IDT) as first-line monotherapy with the use of an algorithm of slow titration for dosing. The use of Prialt has demonstrated fewer and less serious associated adverse effects as compared to IDT morphine, especially when titrated slowly. We will use an average Numerical Rating Scale as our primary outcome and the Oswestry Disability Index(ODI), Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS), Clinical Global Impression of Change Scale including binary satisfaction measures(CGIC), Lawton-Brody Instrumental Activities of Daily Living(IADL) and Short Form-36 as secondary outcome measures.
Interventions
- DRUG Ziconotide 100 MCG(microgram)/ML Intrathecal Solution
- DIAGNOSTIC_TEST Quantitative sensory testing
- DIAGNOSTIC_TEST Serum markers: Interleukin-1, Interleukin-6, and tumor necrosis factor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2016-11-03 |
| Est. Completion | 2020-12-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03321955
The ClinicalTrials.gov registry entry for NCT03321955 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albany Medical College, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ziconotide 100 MCG(microgram)/ML Intrathecal Solution is the first listed.
NCT03321955 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03321955 about?
NCT03321955 is a clinical study titled "Ziconotide as First-Line IDT". The primary objective of this study is to prospectively examine outcomes in 12 patients using ziconotide Intrathecal Drug Therapy(IDT) as first-line monotherapy with the use of an algorithm of slow titration for dosing. The use of Prialt has demonstrated fewer and less serious associated adverse eff...
What is the current status of trial NCT03321955?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 13 participants. The study started on 2016-11-03. Estimated completion is 2020-12-30.
What interventions are being tested in trial NCT03321955?
The interventions under investigation include: Ziconotide 100 MCG(microgram)/ML Intrathecal Solution (DRUG), Quantitative sensory testing (DIAGNOSTIC_TEST), Serum markers: Interleukin-1, Interleukin-6, and tumor necrosis factor (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03321955?
This trial is sponsored by Albany Medical College, which has 52 total clinical trials registered on ClinicalTrials.gov.
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