NCT05265442Completed
Real-life Observational Study of Cancer Pain Management With Methadone
DUNE - A Real-life Observational Study of Cancer Pain Management With Methadone (Zoryon®) in Patients Inadequately Relieved by Other Level 3 Opioids.
Source: ClinicalTrials.gov · Last updated 31 Oct 2024
Brief summary (registry, in English)
Study rational. Methadone is a distinctive opioid because of its pharmacological characteristics and its multiple modes of action, reinforcing its therapeutic value in managing advanced cancer pain, particularly in cases with a neuropathic component. However, the complex pharmacodynamics of methadone makes its prescription sometimes challenging. There is a wide inter-individual variability of its half-life. This long half-life is a valued characteristic for the management of patients treated for an addictive disorder. However, in the context of pain management, it greatly complicates the switch from and to another opioid, accentuating the risk of overdose. This is the reason why LBR, willing to improve his knowledge about Methadone in real life clinical practice wants to performe this study. We anticipate that most patients will receive one of the above-described protocols, but we must anticipate that other protocols may be used in clinical practice in the absence of specific recommendations. Therefore it is of utmost relevance to describe the safety when initiating treatment with Zoryon® during the crucial period from D1 until the day of optimal dosage is determined (DOD) as the clinical practice may vary from a practician to another, and then until the routine follow-up visit one month after initiation of the treatment (D28).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 136 (actual)
- First submitted
- 22 Feb 2022
- Start date
- 21 Feb 2022
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- RECORDATI GROUP
- Diseases
- Childhood cancers
- NCT number
- NCT05265442
What you commit to
- Study type: Observational
- Participants enrolled: 136
- From 21 Feb 2022 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- patients participating, or having participated within the previous month, in a clinical trial evaluating a new pain management treatment will be excluded, except for patients participating in the French experimentation of the use of therapeutical cannabis
Who the study is looking for
- Patients with intractable cancer pain inadequately relieved by other opioids (ineffective and/or excessive adverse events) AND for whom switching from opioid to Zoryon® has been prescribed.
- be aged 15 years or older;
- suffer from cancer pain;
- be treated with a level 3 opioid with inadequate pain relief, i.e., ineffective, excessive adverse effects, or both;
- have a prescription to initiate Zoryon® treatment.
Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| LBR Coordinator of this site? Confirm its status | Puteaux | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.