NCT04321408 OP2C : Prialt® Observatory in Clinical Practice
| NCT ID | NCT04321408 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut Cancerologie de l'Ouest |
| Condition | Refractory Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2020-07-10 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2020-07-10 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Ziconotide is a strong analgesic marketed since 2005 in Europe and reserved for the intrathecal route. Its efficacy has been proven in particular by 3 randomized clinical studies. It is particularly effective on neuropathic pain and its main advantages are its power of action, the absence of bone marrow toxicity, and the absence of respiratory depression. In addition, there were no signs of withdrawal when stopping the drug, or of tachyphylaxis. However, during these studies many adverse reactions were highlighted, especially neuropsychiatric which limited its use. This toxicity was mainly related to the administration of too high doses, especially at the start of treatment (too fast titration). In recent years, the use of intrathecal ziconotide has become a pertinent option. Indeed, it is recommended as first-line among the intrathecal treatment options. However, there is a lack of data on the current use of ziconotide in current practice. The objective of the study will be to describe the practical methods of using intrathecal treatments containing ziconotide.
Eligibility 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
Contact & Investigator
DENIS DUPOIRON, MD
STUDY DIRECTOR
Institut de Canérologie de l'Ouest
Frequently Asked Questions
Who can join the NCT04321408 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Refractory Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04321408 currently recruiting?
Yes, NCT04321408 is actively recruiting participants. Contact the research team at denis.dupoiron@ico.unicancer.fr for enrollment information.
Where is the NCT04321408 trial being conducted?
This trial is being conducted at Angers, France, La Roche-sur-Yon, France, Lyon, France, Montpellier, France and 11 additional locations.
Who is sponsoring the NCT04321408 clinical trial?
NCT04321408 is sponsored by Institut Cancerologie de l'Ouest. The principal investigator is DENIS DUPOIRON, MD at Institut de Canérologie de l'Ouest. The trial plans to enroll 300 participants.