Observing the use of Ziconotide for treating severe chronic pain
OP2C : Prialt® Observatory in Clinical Practice
This study looks at how well Ziconotide works for people with severe chronic pain and whether it’s safe to use in real-life situations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Cancerologie de l'Ouest Academic / other |
| Locations | 17 sites (Angers and 16 other locations) |
| Trial ID | NCT04321408 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the use of Ziconotide, a potent analgesic administered via intrathecal injection, for patients suffering from refractory chronic pain. The study aims to gather data on its effectiveness and safety in clinical practice, particularly regarding the management of neuropsychiatric adverse reactions associated with its use. By analyzing real-world outcomes, the study seeks to enhance understanding of optimal dosing and administration practices for Ziconotide. The findings could help refine treatment protocols and improve patient care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who experience severe refractory chronic pain and are suitable for intrathecal analgesia with Ziconotide.
Not a fit: Patients with contraindications to Ziconotide will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safe and effective use of Ziconotide, potentially improving pain management for patients with refractory chronic pain.
How similar studies have performed: While Ziconotide has been previously studied in randomized clinical trials, this observational approach aims to gather new data on its current clinical use, making it a novel contribution to the existing literature.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years old * Severe refractory chronic pain requiring intrathecal analgesia * Candidate for intrathecal analgesia treatment with ziconotide * Patient informed about the study and agreeing to take part in. Exclusion Criteria: * Contraindications to ziconotide
Where this trial is running
Angers and 16 other locations
- Institut de Cancerologie de L'Ouest — Angers, France (Active_not_recruiting)
- Centre Hospitalier Departemental La Roche Sur Yon — La Roche-sur-Yon, France (Active_not_recruiting)
- Centre Leon Berard — Lyon, France (Active_not_recruiting)
- Institut de Cancerologie de Montpellier — Montpellier, France (Suspended)
- Clinique Breteche — Nantes, France (Suspended)
- Chu Nice — Nice, France (Suspended)
- Institut Curie — Saint-Cloud, France (Suspended)
- Hopital - Foch — Suresnes, France (Active_not_recruiting)
- University of Freiburg — Freiburg im Breisgau, Germany (Recruiting)
- Justus-Liebig-Universitat — Giessen, Germany (Recruiting)
- Jena University Hospital — Jena, Germany (Recruiting)
- Hospital Universitario Puerta Del Mar — Cadiz, Spain (Recruiting)
- Hospital General Universitario Santa Lucía — Cartagena, Spain (Recruiting)
- Hospital Universitario Virgen de las Nieves — Granada, Spain (Recruiting)
- Hospital Complexo Hospitalario de Ourense — Ourense, Spain (Recruiting)
- Hospital Universitario Virgen del Rocío — Seville, Spain (Recruiting)
- Hospital Clínico Universitario de Valencia — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Denis Dupoiron, Md
- Email: denis.dupoiron@ico.unicancer.fr
- Phone: +33 241352700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.