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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: Completed Phase 4 study, sponsored by Albany Medical College.
NCT03321955 is a Phase 4 study that has completed, run by Albany Medical College. The registered enrollment target is 13 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This scale allows the subject to quantify their pain numerically, with 10 being the worst pain imaginable. This scale describe subject reported pain at its worst and best in the week prior to reporting, as well as total pain on average, and at the time of documentation. The mean of these scores will be used as the primary outcome. This scale also includes a question of subject experienced global improvement in which the patient is asked to quantify their overall change in pain with 0 being no ch
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 |
What the finished NCT03321955 record still lists
NCT03321955 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Ziconotide 100 MCG(microgram)/ML Intrathecal Solution is the first listed.
NCT03321955 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03321955's enrollment target sits among peer trials
13 1910th of 2000 higher than 88 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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