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Morphine Slow-release Capsultes in Substitution Therapy

2014-08-27 03:15:30 | BioPortfolio

Summary

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

Description

The objective of this study is to compare the effectiveness of slow-release oral morphine (SROM) treatment in patients that previously have been treated with methadone. Efficacy is assessed by the frequency of by-consumption of illicit substances. The primary efficacy endpoint in this study is the proportion of positive urine tests for by-consumption of target substances per subject. Target substances are defined as all opioids except the study drug.

The proportions are compared between substitution with methadone and SROM treatment in a crossover design.

The secondary endpoints are:

1. The effects of SROM on retention rate.

2. By-consumption of other drugs (cocaine, alcohol, cannabis, benzodiazepines).

3. Occurring psychopathological and somatic symptoms.

4. Effect of treatment on the ECG (QTc prolongation).

5. Group characterisation of patients that is keen to change the medication.

6. The change in dosage of treatment over time.

7. Self-assessed craving for Opioids.

8. Self-assessed satisfaction with treatment.

9. Nature, frequency and severity of occurring adverse events in the two treatment groups.

10. Assessment of safety parameters.

Study Design (Methodology):

This is a multicentre, multinational phase III study. It is conducted using a randomised, open label cross-over design. The subjects will be randomised to either 10 weeks of treatment with methadone or SROM. After an adjustment phase of one week they first will be medicated for 10 weeks with the treatment to which SUB9001 - Integrated Study Protocol 9/58 June 13, 2009 they have been randomised. The cross-over, in which all subjects change to their opposite treatment, will serve for an additional adjustment phase of one week. After the second and new adjustment phase they are treated for 10 weeks with the newly adjusted medication. After the end of week 22 all participants continue with or switch back to SROM for another 6 month (week 23 to 47).

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Opiate Dependent

Intervention

Sevre-Long™, Slow release oral morphine, Methadone

Location

Zurich
Switzerland

Status

Recruiting

Source

Mundipharma Medical Company

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:30-0400

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Medical and Biotech [MESH] Definitions

Medical treatment for opioid dependence using a substitute opiate such as METHADONE or BUPRENORPHINE.

A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Methadone is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)

The principal alkaloid in opium and the prototype opiate analgesic and narcotic. Morphine has widespread effects in the central nervous system and on smooth muscle.

An opioid analgesic made from MORPHINE and used mainly as an analgesic. It has a shorter duration of action than morphine.

Strong dependence, both physiological and emotional, upon morphine.

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