The Pain Pen for Breakthrough Cancer Pain
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms Pain |
Drug: Subcutaneous hydromorphone delivered by pain pen |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Breakthrough Cancer Pain: A Randomized Trial Comparing Oral Morphine Immediate Release and Self-Administration of Subcutaneous Hydromorphone Using an Injection Pen |
- Pain intensity difference (PID) at t=15 minutes [ Time Frame: t=15 minutes ] [ Designated as safety issue: No ]
- PID 5' [ Time Frame: 5 min ] [ Designated as safety issue: No ]
- PID 30' [ Time Frame: 30 min ] [ Designated as safety issue: No ]
- PID 45' [ Time Frame: 45 min ] [ Designated as safety issue: No ]
- PID 60' [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
- time to onset of meaningful pain relief [ Time Frame: time to onset ] [ Designated as safety issue: No ]
- global efficacy rating at 60' [ Time Frame: 60 min ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2005 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
-
Drug: Subcutaneous hydromorphone delivered by pain pen
Breakthrough pain is an exacerbation of severe pain that occurs on a background of otherwise controlled pain. Breakthrough pain is common in patients with advanced cancer. Current medications to treat breakthrough pain include oral immediate release opioid formulations and more recently oral transmucosal fentanyl citrate.
The pain pen study is a randomized controlled double blind cross-over study comparing the efficacy of oral immediate release morphine with that of subcutaneous hydromorphone, injected through a so called pain pen, on breakthrough pain in cancer patients. Preliminary experience with the pain pen suggests that it has a more rapid time of onset of pain relief than oral formulations.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Dr. Joost L.M. Jongen, Erasmus MC |
| ClinicalTrials.gov Identifier: | NCT00125801 History of Changes |
| Other Study ID Numbers: | EMC 02-115 |
| Study First Received: | August 1, 2005 |
| Last Updated: | October 13, 2008 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Additional relevant MeSH terms:
|
Neoplasms Hydromorphone Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on October 16, 2012
