NCT03685162

Observational Study to Evaluate Levomethadone Safety and Effectiveness in Subjects Under Opioid Maintenance Treatment

Observational, Prospective Study to Evaluate Levomethadone Safety Profile and Effectiveness in Subjects Under Opioid Maintenance Treatment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 103 (actual)
• Sponsor: L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicentre, prospective, observational, non-interventional, open- ended trial, collecting data from male and female patients aged ≥ 18 years, with a diagnosis of opioid addiction according to ICD-10 (F11.2), treated with therapeutic doses of levomethadone according to the routine medical practice.

Detailed description

Multicentre, prospective, observational, non-interventional, open- ended trial, collecting data from male and female patients aged ≥ 18 years, with a diagnosis of opioid addiction according to ICD-10 (F11.2), treated with therapeutic doses of levomethadone according to the routine medical practice. The study is divided in two different consecutive parts: * Part 1 \[from Informed Consent form (ICF) to last data collected at V4\]: patients enrolled are receiving levomethadone maintenance treatment according to clinical practice. * Part 2 (after V4 up to FU): patients are in opioid maintenance treatment with any drug (including levomethadone) according to clinical practice. The maximum duration on-study for a patient will be 405 days \[from ICF signature (-30 days from V1) to FU (=360 + 15)\]. This study is an open-ended trial. This means that for the enrolment and for the study, no maximum duration has been established. The study, which is a voluntary Post Authorization Safety Study (PASS), will be carried out on approximately 10 centers in Italy. The objectives are to provide further data on the safety profile after long term use and effectiveness of levomethadone, administered according Summary of Product Characteristics (SmPC) and in a real word clinical setting, in opioid-addicted patients undergoing maintenance treatment. Safety will be assessed throughout all the study and safety data will be described and analysed based on Adverse Drug Reactions and corrected QT (QTc) prolongation at 12-lead electrocardiogram (ECG), where available. The effectiveness outcomes are the evaluation of levomethadone maintenance treatment according to investigator's judgment at V4(180 days), based on different questionnaires and assessment.

Conditions

• Opioid Addiction

Timeline

• Start date: 2018-02-27
• Primary completion: 2023-02-16
• Completion: 2023-02-16
• First posted: 2018-09-26
• Last updated: 2023-10-24

Locations

1 site across 1 country: Italy