N/A
N=219
Patient Registry of Intrathecal Pain Management in Europe for Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.
Pain Management · Severe Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT02268812 ↗Enrolled (actual)
219
Serious AEs
39.1%
Results posted
Oct 2018
Primary outcome: Primary: Average Overall Change From Baseline (Visit 1) in Visual Analog Scale of Pain Intensity (VASPI) — -3.23; -15.24; -1.50; -18.40 Units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eisai Limited
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Overall Change From Baseline (Visit 1) in Visual Analog Scale of Pain Intensity (VASPI) |
-3.23; -15.24; -1.50; -18.40; -3.78; -9.33 | — |
| SECONDARY Overall Change in Pain Severity and Pain Interference From Baseline (Visit 1) to Month 12 (Visit 5) |
-0.41; -0.77; -0.09; -0.99; -0.52; -0.42 | — |
| SECONDARY Overall Change in Pain Severity and Pain Interference From Baseline (Visit 1) to Termination Visit |
-0.27; -1.11; -0.04; -0.74; -0.77; -1.05 | — |
| SECONDARY Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) |
66; 88; 46; 48; 56; 54 | — |
Summary
This is an open-label, long-term, multi-center multi-national post-marketing observational registry. The objective of this study is to monitor the long-term efficacy, safety, tolerability and quality of life outcomes associated with ziconotide (Prialt) and other analgesics utilized in the intrathecal (IT) management of severe chronic pain.
Eligibility Criteria
Inclusion Criteria
Patients will be eligible to enroll onto the registry if they have given informed consent and meet the following criteria:
- Patient's physician has deemed that the initiation/switch of intrathecal analgesia appropriate, or patient is presently utilizing ziconotide (Prialt)
- Patient has a diagnosis of severe, chronic pain for which intrathecal infusion is indicated
- Patient is at least 18 years of age at time of study entry
All patients starting ziconotide (Prialt) should comply with the indications and warnings in the current approved version of the Summary of Product Characteristics (SmPC).
Exclusion Criteria
Patients who meet any of the following criteria will not be eligible to enroll in the registry:
- Patient is a pregnant or lactating female
- Patient is receiving intrathecal chemotherapy
Data sourced from ClinicalTrials.gov (NCT02268812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.