NeoplasmsPhase 3NCT00125801
The Pain Pen for Breakthrough Cancer Pain
A Phase 3 study testing Subcutaneous hydromorphone delivered by pain pen in people with Neoplasms and Pain, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Subcutaneous hydromorphone delivered by pain pen
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2005to May 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breakthrough Cancer Pain: A Randomized Trial Comparing Oral Morphine Immediate Release and Self-Administration of Subcutaneous Hydromorphone Using an Injection Pen
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.
Read the detailed description
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.
- Being tested
- Subcutaneous hydromorphone delivered by pain pen
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous hydromorphone delivered by pain penDrug
Subcutaneous hydromorphone delivered by pain pen during breakthrough pain episodes, at max 4 daily. Dose established by opioid conversion from baseline opioids.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity difference (PID) at t=15 minutes
Measured: t=15 minutes
Secondary outcomes (6)
PID 5'
Measured: 5 min
PID 30'
Measured: 30 min
PID 45'
Measured: 45 min
PID 60'
Measured: 60 minutes
time to onset of meaningful pain relief
Measured: time to onset
global efficacy rating at 60'
Measured: 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionMay 2008
- Study completionMay 2008
Why it stopped: Lack of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Joost L. Jongen, MD, Principal investigator, Dept. Neurology, Erasmus MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125801
- Sponsor's protocol ID
- EMC 02-115
- Status last verified
- Oct 2008
- First submitted
- 1 Aug 2005
- Last updated
- 15 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Enting 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.
PubMed 15733812
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breakthrough Cancer Pain: A Randomized Trial Comparing Oral Morphine Immediate Release and Self-Administration of Subcutaneous Hydromorphone Using an Injection Pen
- ClinicalTrials.gov ID
- NCT00125801
- Acronym / sponsor ID
- EMC 02-115
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patients
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 2 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous hydromorphone delivered by pain penSubcutaneous hydromorphone delivered by pain pen during breakthrough pain episodes, at max 4 daily. Dose established by opioid conversion from baseline opioids. | Drug | – |
Primary outcome
Pain intensity difference (PID) at t=15 minutes
Time frame: t=15 minutes
6 secondary outcomes
PID 5'
Time frame: 5 min
PID 30'
Time frame: 30 min
PID 45'
Time frame: 45 min
PID 60'
Time frame: 60 minutes
time to onset of meaningful pain relief
Time frame: time to onset
global efficacy rating at 60'
Time frame: 60 min
Results and safety
The study was stopped early (reason given: Lack of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2008.
- Background: PubMed 15733812Enting 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joost L. Jongen, MD principal investigator
Dept. Neurology, Erasmus MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Subcutaneous hydromorphone delivered by pain pen in people with Neoplasms and Pain, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity difference (PID) at t=15 minutes (time frame: t=15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00125801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2008.