Real-life Observational Study of Cancer Pain Management With Methadone in

Status Not yet recruiting

Clinical Trial Summary

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).

Clinical Trial Description

To describe the occurrence of overdose and QTc prolongation in patients initiating a treatment with Zoryon® for intractable cancer pain not adequately relieved from other level 3 opioids, from the day of instauration (D1) to the day of determination of the optimal dose for the patient (DOD: Day of Optimal Dosage (DOD): the dosage of Zoryon® will be considered optimal after two consecutive days without modification to the posology (usually within the first week) AND pain relief for the patient. ;

Study Design

Related Conditions & MeSH terms

Cancer Pain

Clinical Trial Details

NCT number	NCT05265442
Study type	Observational
Source	Laboratoires Bouchara-Recordati
Contact	Catherine Koch
Phone	+33145191103
Email	koch.c@recordati.com
Status	Not yet recruiting
Phase
Start date	February 23, 2022
Completion date	September 30, 2023

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Real-life Observational Study of Cancer Pain Management With Methadone in Patients Inadequately Relieved by Other Level 3 Opioids. — DUNE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms