Clinical trial · Interventional
Double Bedtime Dosing During Immediate-release Morphine Administration to Cancer Patients
Double Bedtime Dosing During Immediate-release Morphine Administration to Cancer Patients: A Randomized, Double-blind Cross-over Comparison of a Double Bedtime Dose Ver-sus Two Standard Doses at Bedtime and at Night
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a double -blind randomized crossover study to provide evidence for the expert advice based recommendation of the Expert Working Group of the European Association for Palliative Care (EAPC) that patients during treatment with IR morphine are given a double dose at bed-time that replaces the next 4-hourly dose during night. In addition to the primary, blinded clinical part of the study, an experimental part is also included. This part consists of two open study days were morphine IR is given in the same fashion as the clinical study. The aim is to study whether pharmacokinetic data supports the clinical data. The use of a double-bedtime IR morphine dose is equal to regularly scheduled IR morphine every 4-hour during night in respect to pain relief during night for patients with pain caused by malignant disease
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| double dose Morphine | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
| single dose Morphine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- double dose once
- description
- double dose immediate-release oral morphine at bedtime in cancer patients, placebo after 4 hours
- interventionNames
- Drug: double dose Morphine
- Drug: placebo
- type
- EXPERIMENTAL
- label
- single dose twice
- description
- single dose immediate-release oral morphine at bedtime in cancer patients, second single dose after 4 hrs
- interventionNames
- Drug: single dose Morphine
Primary outcomes (2)
- measure
- Primary efficacy variable
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with malignant disease * Age more than 18 year * Regular use of oral morphine or pain that indicates start of opioids for moderate or severe pain according to the WHO guidelines for treatment of cancer pain Exclusion criteria * Known morphine intolerance * History of drug abuse * Decreased gastrointestinal uptake of oral medications * Pregnancy or breast-feeding * General health condition, psychiatric disease or cognitive function failure giving that the patient is not competent to complete questionnaires.
References
Publications (1)
- RESULTDale O, Piribauer M, Kaasa S, Moksnes K, Knobel H, Klepstad P. A double-blind, randomized, crossover comparison between single-dose and double-dose immediate-release oral morphine at bedtime in cancer patients. J Pain Symptom Manage. 2009 Jan;37(1):68-76. doi: 10.1016/j.jpainsymman.2007.12.016. Epub 2008 May 27. PMID 18504090