Adverse effects of morphine and oxycodone for treatment of pain in dying patients.

Neurotoxic adverse effects of morphine and oxycodone in continuous subcutaneous infusion for treatment of pain in terminal patients with diminished renal function: a Randomized Controlled Trial. - MOSART-study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002192-25-NL

Enrollment

234

Registered

2017-07-26

Start date

2017-12-06

Completion date

Unknown

Last updated

2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Product Name: Oxycodone Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: OXYCODONE HYDROCHLORIDE CAS Number: 124-90-3 Other descriptive name: OXYCODONE HYDROCHLORIDE Product

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - minimal age of 18 years at the time of inclusion; - the subject is in the terminal phase, i.e. death in the near future is expected by the treating physician; - start of CSCI with an opioid for treatment of pain is indicated by the treating physician; - willingness to allow one-time blood collection for assessment of renal function (eGFR); - a signed informed consent is given by the participant or his/her legal representative. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 234 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 234

Exclusion criteria

Exclusion criteria: - delirium at the time of inclusion; - opioid induced hyperalgesia (OIH) at the time of inclusion; - a medical necessity to apply a different opioid than morphine or oxycodone, such as previously demonstrated non-response to morphine or oxycodone (defined as a complete absence of any pain reduction after appropriate dosage), previously demonstrated unacceptable side effects of morphine or oxycodone, or a medical indication for an opioid with NMDA-receptor-antagonistic properties (currently only known for methadone); - a documented allergy for morphine or oxycodone.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this study is to investigate whether and to what extent the occurrence of the neurotoxic adverse effect delirium differs between morphine and oxycodone, administered by continuous subcutaneous infusion (CSCI), for the treatment of pain in dying patients with a diminished renal function.;Secondary Objective: The secondary objective of this study is to investigate whether and to what extent the occurrence of the neurotoxic adverse effect allodynia/hyperalgesia differs between morphine and oxycodone, administered by continuous subcutaneous infusion (CSCI), for the treatment of pain in dying patients with a diminished renal function.;Primary end point(s): The occurrence of the neurotoxic adverse effect delirium at any time between start of continuous subcutaneous infusion of the opioid and death.;Timepoint(s) of evaluation of this end point: After inclusion of 30 participants in each group an interim analysis will be performed.	—

Measure

Time frame

Main Objective: The main objective of this study is to investigate whether and to what extent the occurrence of the neurotoxic adverse effect delirium differs between morphine and oxycodone, administered by continuous subcutaneous infusion (CSCI), for the treatment of pain in dying patients with a diminished renal function.;Secondary Objective: The secondary objective of this study is to investigate whether and to what extent the occurrence of the neurotoxic adverse effect allodynia/hyperalgesia differs between morphine and oxycodone, administered by continuous subcutaneous infusion (CSCI), for the treatment of pain in dying patients with a diminished renal function.;Primary end point(s): The occurrence of the neurotoxic adverse effect delirium at any time between start of continuous subcutaneous infusion of the opioid and death.;Timepoint(s) of evaluation of this end point: After inclusion of 30 participants in each group an interim analysis will be performed.

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Secondary

Measure	Time frame
Secondary end point(s): The occurrence of the neurotoxic adverse effect allodynia/hyperalgesia at any time between start of continuous subcutaneous infusion of the opioid and death.;Timepoint(s) of evaluation of this end point: After inclusion of 30 participants in each group an interim analysis will be performed.	—

Countries

Netherlands

Contacts

Public ContactResearch Information

Center of Expertise in Palliative Care, Maastricht University Medical Centre

mark.martens@mumc.nl0031(0)433877392

Outcome results