Morphine Slow-release Capsules in Substitution Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Medical Company
ClinicalTrials.gov Identifier:
NCT01079117
First received: March 1, 2010
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Opiate Dependent
Drug: Sevre-Long™
Drug: Slow release oral morphine
Drug: Methadone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised, Controlled Clinical Study Regarding the Feasibility of Converting Opiate Dependents From Methadone Substitutes to Slow Release Morphine Sulphate (Sevre-Long™)

Resource links provided by NLM:


Further study details as provided by Mundipharma Medical Company:

Primary Outcome Measures:
  • Proportion of positive urine tests for by-consumption of target substances per subject [ Time Frame: each week during the 22 week cross-over phase ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Secondary Outcome Measures [ Time Frame: throughout the 22 week cross over period ] [ Designated as safety issue: No ]
    The effects of SROM on retention rate

  • By-consumption of other drugs (cocaine, alcohol, cannabis, benzodiazepines) [ Time Frame: throughout the 22 week cross over period ] [ Designated as safety issue: No ]
  • Occurring psychopathological and somatic symptoms. [ Time Frame: througout the 22 week cross over period ] [ Designated as safety issue: No ]
  • Effect of treatment on the ECG (QTc prolongation) [ Time Frame: throughout the 22 week cross over phase ] [ Designated as safety issue: No ]
  • Group characterisation of patients that is keen to change the medication [ Time Frame: throughout the 22 week cross over period ] [ Designated as safety issue: No ]
  • The change in dosage of treatment over time [ Time Frame: throughout the 22 week cross over period ] [ Designated as safety issue: No ]
  • Self-assessed craving for Opioids [ Time Frame: throughout the 22 week cross over period ] [ Designated as safety issue: No ]
  • Self-assessed satisfaction with treatment. [ Time Frame: throughout the 22 week cross over period ] [ Designated as safety issue: No ]
  • Nature, frequency and severity of occurring adverse events in the two treatment groups [ Time Frame: throughout the 22 week cross over period ] [ Designated as safety issue: No ]
  • Assessment of safety parameters [ Time Frame: throughout the 22 week cross over period ] [ Designated as safety issue: Yes ]

Enrollment: 276
Study Start Date: October 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sevre-Long™
slow release oral morphine
Drug: Sevre-Long™
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 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).
Drug: Slow release oral morphine
Active Comparator: Methadone
Methodone
Drug: Methadone

Detailed 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079117

Locations
Switzerland
Zurich, Switzerland
Sponsors and Collaborators
Mundipharma Medical Company
  More Information

Additional Information:
Publications:
Responsible Party: Mundipharma Medical Company
ClinicalTrials.gov Identifier: NCT01079117     History of Changes
Other Study ID Numbers: SUB9001, 2008-002185-60
Study First Received: March 1, 2010
Last Updated: March 27, 2014
Health Authority: Switzerland: Swissmedic
Germany: BfArM

Keywords provided by Mundipharma Medical Company:
Opiate
Methadone
Slow Release Oral Morphine (SORM)
Sevre-Long™

Additional relevant MeSH terms:
Morphine
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on October 01, 2014