Clinical trial · Interventional
The Pain Pen for Breakthrough Cancer Pain
Breakthrough Cancer Pain: A Randomized Trial Comparing Oral Morphine Immediate Release and Self-Administration of Subcutaneous Hydromorphone Using an Injection Pen
NCT00125801CI-TRIAL-00001728terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of patients
Summary
Brief summary (as posted)
The purpose of this study is to see whether injection of hydromorphone through a subcutaneous injection device is more effective in treating breakthrough cancer pain than oral morphine.
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Subcutaneous hydromorphone delivered by pain pen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Pain intensity difference (PID) at t=15 minutes
- timeFrame
- t=15 minutes
Secondary outcomes (6)
- measure
- PID 5'
- timeFrame
- 5 min
- measure
- PID 30'
- timeFrame
- 30 min
- measure
- PID 45'
- timeFrame
- 45 min
- measure
- PID 60'
- timeFrame
- 60 minutes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stable cancer pain requiring the equivalent of 60-1000 mg oral morphine/day * 1-4 breakthrough pain episodes/day * Patients must be able, in the opinion of the investigator, to fully comply with trial requirements * Patients who have given written informed consent Exclusion Criteria: * Uncontrolled pain * Women who are pregnant, lactating or intend to become pregnant * Cardiopulmonary disease that would increase the risk of opioids * Neurologic or psychiatric disease that would compromise data collection * Recently started chemotherapy or radiotherapy in as far as it would be effective in lowering breakthrough pain
References
Publications (1)
- BACKGROUNDEnting RH, Mucchiano C, Oldenmenger WH, Fritzon M, Wallen A, Goslinga-van der Gaag S, Sillevis Smitt PA, Delhaas E. The "pain pen" for breakthrough cancer pain: a promising treatment. J Pain Symptom Manage. 2005 Feb;29(2):213-7. doi: 10.1016/j.jpainsymman.2004.05.010. PMID 15733812