Morphine Slow-release Capsules in Substitution Therapy

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the effectiveness of slow release oral morphine treatment in patients that previously have been treated with methadone

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mundipharma Medical Company
• Treatments: Methadone; Morphine

Criteria

Inclusion criteria:

• Minimum age: 18 years

• Fixed abode

• At least 26 weeks of treatment (up to date) receiving a minimum dose of 50 mg methadone or

≥ 25 mg/day levomethadone at inclusion. Patients on levomethadone must be informed and agree to be switched to methadone

• Mature and capable of acting responsibly, in possession of all mental faculties

• Female subjects must have a negative urine pregnancy test recorded prior to the first dose of study medication and regular negative urine pregnancy tests every 4 weeks. SUB9001 - Integrated Study Protocol 10/58 June 13, 2009

• Hormonal contraception (oral, transdermal, vaginal, intrauterine or subcutaneous) by women of child-bearing age

• No intention of reducing the substitute medication during the trial

• Acceptance of the trials rules and regulations

• Acceptance to participate in the study.

Exclusion criteria:

• (Desired) pregnancy during the trial

• Breastfeeding women

• Grave or acute somatic illnesses (e.g. cardio-vascular, serious kidney or liver affection (ALAT or ASAT > 5x augmented)) or other somatic disorder

• If suffering from severe unstable mental health problems

• If MAO-Inhibitors or are being taken

• Intracranial injury

• Intracranial hypertension

• History of epilepsy

• Severe chronic obstructive lung disease

• Chronic respiratory failure

• Known hypersensitivity to morphine or methadone

• Pancreatitis

• Paralytic ileus

• Baseline QTc interval greater than 450 msec

• Long QT Syndrome

• Patients who have participated in another clinical research study involving a new chemical entity within 3 months of study entry

• Patients with pending imprisonment at the time of inclusion.