NCT02062723

Observational Study to Assess the Efficacy and Tolerability of Eptadone®, in Heroin Addicted Patients in a MMT

Prospective Observational Study to Assess the Efficacy and Tolerability of Eptadone®, in Heroin Addicted Patients Undergoing a Methadone Maintenance Treatment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 515 (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

The efficacy and tolerability of Eptadone® in the context of a maintenance program will be evaluated in an observational prospective, multicenter study, in heroin addicted patients.

Detailed description

515 patients have been selected among all patients addicted to heroin according ICD-10, in maintenance treatment with Eptadone, observed in the involved sites. The investigators have used the treatment schemes with Eptadone conform to the registered use. The enrollment has been competitive. Patients met incl/excl and that have signed the informed consent have been observed for 1 year. Follow up visits have been performed according to routine procedures, for patients related to the centres at 3/6/12 months post V1. During the visits patients have been assessed by validated and used as clinical practice questionaries. Safety and tolerability have been assessed through the collection of adverse reactions and of laboratory tests.

Conditions

• Heroin Addiction

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2014-02-14
• Last updated: 2014-02-14

Locations

22 sites across 1 country: Germany