Clinical trial · Interventional
A Efficacy and Safety Trial of Controlled Release (CR) Morphine in Cancer Patients
A Double-blind, Randomized, 2-way Cross-over, Phase II, Efficacy Trial in Cancer Patients to Assess the Overall Efficacy, Patient Preference, Morphine Related Side Effect Profile and Safety of the Egalet® Controlled Release Morphine Formulation 30-240 mg Once Daily Compared to MST Continus® 15-120 mg Twice Daily After 2 Weeks of Treatment
- 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)
The purpose of the study is to determine the effect of Egalet® Morphine once daily compared to MST Continus twice daily on pain intensity and use of rescue medication for break through pain after 2 weeks of treatment in patients with pain due to cancer.
Conditions
Conditions (2)
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 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Morphine Sulphate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Egalet® morphine
- interventionNames
- Drug: Morphine Sulphate
- type
- ACTIVE_COMPARATOR
- label
- MST Continus®
- interventionNames
- Drug: Morphine Sulphate
Primary outcomes (1)
- measure
- Use of rescue medication
- timeFrame
- 2 weeks treatment
Secondary outcomes (1)
- measure
- Pain intensity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The patient has stable strong opioid use equipotent to 30-240 mg oral morphine sulphate daily for a minimum of 2 weeks prior to entering the run-in phase. * The patient has opioid-sensitive pain caused by active cancer. * The patient is aged minimum 18 years. Exclusion Criteria: * The patient has a life expectancy less than 2 months. * The patient has received chemotherapy or radiation therapy less than 4 weeks prior to entering run-in phase * Patients with medical conditions contraindicating morphine treatment * The patient has hepatic disease or impaired kidney function * The patient is taking monoamine oxidase inhibitors (MAOIs) or has taken a MAOI within two weeks prior to entering baseline. * The patient is taking other opioid agonists or antagonists, zidovudine or cimetidine.
References
Publications (0)
Data not yet available