Pain ManagementNCT02578459
A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain
A study testing Intrathecal Drug Delivery System and Conventional Medical Management in people with Pain Management and Cancer Pain, run by Flowonix Medical at 1 site in United States.
Trial summary
The purpose of this study is to compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients with pancreatic cancer pain. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Pain Management, Cancer Pain
- What is being tested?
- Intrathecal Drug Delivery System and Conventional Medical Management
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Sep 2018
- Phase
- Interventional
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has Stage IV pancreatic cancer.
- Patient agrees not to be treated by other oncologists or anesthesiologists during the study.
- Patient agrees not to obtain pain medications from other physicians during the study.
- Patient is at least 22 years of age.
- Investigator considers the patient to be able and willing to fulfill all study requirements.
- Patient is able to understand the study and provide written informed consent to participate in the study.
Who cannot join
- Patient meets any of the contraindications for use of the Prometra Programmable Infusion System (for patients in the ITDD group).
- Patient is enrolled in another clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients with pancreatic cancer pain.
Read the detailed description
This study is a non-randomized, open-label, single-center study that will compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients suffering from pancreatic cancer pain.
There will be two treatment groups: Study group (ITDD): These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain. Systemic analgesics will not be prescribed for this group. Control group (CMM): These subjects will be treated with CMM to treat their pain.
A maximum of 30 subjects (maximum of 15 in each treatment group) may be enrolled in this study at one study center.
- Conditions
- Pain Management, Cancer Pain
- Being tested
- Intrathecal Drug Delivery System, Conventional Medical Management
- Keywords
- Cancer pain, Intrathecal therapy, Pain, Pancreatic cancer
- Medical subject headings
- Agnosia, Cancer Pain, Pain, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal Drug Delivery SystemDevice
Also called Prometra Programmable Infusion System
The Prometra Pump is a battery-operated, implantable, programmable infusion pump that dispenses pain medication into the intrathecal space through an implanted infusion catheter.
Conventional Medical ManagementOther
Treatment with conventional medical management will include using standard systemic pain medications such as narcotics, nonsteroidal anti-inflammatory drugs (NSAIDs), and neuropathic medications (examples: gabapentin, Lyrica, Cymbalta) that are typically used to treat pancreatic cancer pain.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Drug Delivery (ITDD) | Experimental | These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain. Receives: Device: Intrathecal Drug Delivery System |
| Conventional Medical Management (CMM) | Active comparator | These subjects will be treated with conventional medical management to treat their pain. Receives: Other: Conventional Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale Pain Scores
Level of pain is rated on the visual analog scale. Pain scores after three months of therapy will be compared to baseline pain scores to see if there is a difference.
Measured: Three months
Secondary outcomes (5)
Survival Rates
Data will be analyzed to test for correlation between survival and pain scores, and survival rates and treatment type.
Measured: Two years
Quality of Life Scores
Difference in quality of life between treatment groups.
Measured: Two years
Cancer Treatments
Difference between treatment group in the number of cancer treatment initiated during the study
Measured: Two years
Hospitalizations and Emergency Room Visits
Difference between treatment group in the number of times they are hospitalized or visit the emergency room during the study
Measured: Two years
Adverse Events
Adverse events reported by each treatment group will be summarized.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startApr 2016
- Primary completionDec 2016 (estimated)
- Study completionSep 2018 (estimated)
Why it stopped: The study was never initiated by sponsor. Patients where never recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flowonix Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel R Kloster, MD, Principal investigator, Menorah Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578459
- Sponsor's protocol ID
- PM-02
- Status last verified
- Jul 2018
- First submitted
- 14 Oct 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain
- ClinicalTrials.gov ID
- NCT02578459
- Acronym / sponsor ID
- PM-02
- Conditions
- Pain Management, Cancer Pain
- Keywords
- Cancer pain, Intrathecal therapy, Pain, Pancreatic cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was never initiated by sponsor. Patients where never recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Flowonix MedicalIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 19 Oct 2015 (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 compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients with pancreatic cancer pain.
Detailed description
This study is a non-randomized, open-label, single-center study that will compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients suffering from pancreatic cancer pain.
There will be two treatment groups: Study group (ITDD): These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain. Systemic analgesics will not be prescribed for this group. Control group (CMM): These subjects will be treated with CMM to treat their pain.
A maximum of 30 subjects (maximum of 15 in each treatment group) may be enrolled in this study at one study center.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Drug Delivery (ITDD) | Experimental | Device: Intrathecal Drug Delivery SystemThese subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain. |
| Conventional Medical Management (CMM) | Active comparator | Other: Conventional Medical ManagementThese subjects will be treated with conventional medical management to treat their pain. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient has Stage IV pancreatic cancer.
- Patient agrees not to be treated by other oncologists or anesthesiologists during the study.
- Patient agrees not to obtain pain medications from other physicians during the study.
- Patient is at least 22 years of age.
- Investigator considers the patient to be able and willing to fulfill all study requirements.
Key exclusion criteria (2 listed)
- Patient meets any of the contraindications for use of the Prometra Programmable Infusion System (for patients in the ITDD group).
- Patient is enrolled in another clinical study.
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 |
|---|---|---|
| Intrathecal Drug Delivery SystemAlso: Prometra Programmable Infusion SystemThe Prometra Pump is a battery-operated, implantable, programmable infusion pump that dispenses pain medication into the intrathecal space through an implanted infusion catheter. | Device | Intrathecal Drug Delivery (ITDD) |
| Conventional Medical ManagementTreatment with conventional medical management will include using standard systemic pain medications such as narcotics, nonsteroidal anti-inflammatory drugs (NSAIDs), and neuropathic medications (examples: gabapentin, Lyrica, Cymbalta) that are typically used to treat pancreatic cancer pain. | Other | Conventional Medical Management (CMM) |
Primary outcome
Visual Analog Scale Pain Scores
Time frame: Three months
Level of pain is rated on the visual analog scale. Pain scores after three months of therapy will be compared to baseline pain scores to see if there is a difference.
5 secondary outcomes
Survival Rates
Time frame: Two years
Quality of Life Scores
Time frame: Two years
Cancer Treatments
Time frame: Two years
Hospitalizations and Emergency Room Visits
Time frame: Two years
Adverse Events
Time frame: Two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Dr. Daniel R. KlosterLink provided by the sponsor.
- Dr. Jaswinder SinghLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Daniel R Kloster, MD principal investigator
Menorah Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal Drug Delivery System and Conventional Medical Management in people with Pain Management and Cancer Pain, run by Flowonix Medical at 1 site in United States.
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 6 inclusion and 2 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: withdrawn, as of the sponsor's last update on 15 Feb 2019. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Visual Analog Scale Pain Scores (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2019.