Chronic PainCONVERT-TDDNCT01924182
Intrathecal Morphine Compared to Conventional Medical Management for Pain Control and Opioid-related Side Effects
A study testing SynchroMed Infusion System and Intrathecal Morphine Sulfate and Conventional Medicine in people with Chronic Pain, run by MedtronicNeuro at 6 sites in United States.
Trial summary
This study compares two different ways to treat pain. The two ways are: 1. continuing to take current pain medication(s) or 2. receiving morphine, a pain medication from a drug pump (a system to deliver drug to your body) that is implanted. None of the procedures or products used in this study are experimental. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- SynchroMed Infusion System and Intrathecal Morphine Sulfate and Conventional Medicine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed and dated Medtronic/IRB approved Informed Consent Form and HIPAA Authorization prior to any study procedures being performed
- Willing and able to attend visits and comply with the study protocol
- Willing and able to abstain from alcohol consumption for the study duration
- At least 18 years of age
- Male or non-pregnant, non-lactating female
- Currently receiving </= 300 mg/day morphine equivalent of systemic opioids at screening
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- Used a stable dose of opioids (no change in type or prescribed frequency or dose) for 30 days prior to the Screening as documented in the medical history
- Used chronic systemic opioids for at least 6 months prior to Screening as documented in medical history
- Per investigator's medical assessment and the subject's medical history, the subject is/has:
- A new candidate for chronic intrathecal drug therapy (including no prior intrathecal/epidural trial for pump infusion therapy)
- A diagnosis of nonmalignant, chronic intractable pain as documented in the medical history
- Medically stable and able to undergo surgery for implantation of the SynchroMed Infusion System
- Completed a psychological evaluation within 6 months prior to Screening
Who cannot join
- Psychological or other health conditions, financial, and/or legal concerns (within 3 months prior to Screening) that would interfere with the subject's ability to fulfill the requirements of the protocol as per the investigator's opinion
- A history of alcohol abuse or any illicit drug use within 2 years prior to Screening
- A positive urine test for illicit drugs at Screening (Exception: If subject has a physician's prescription for an illicit drug; for example, medical marijuana)
- Known diagnosis of moderate to severe sleep apnea.
- Prescribed Continuous Positive Airway Pressure (CPAP), Adaptive Servo-Ventilation (ASV) therapy or an oral appliance prescribed for the treatment of moderate to severe sleep apnea (current or previous history)
- An active malignancy or has been diagnosed with cancer and has not been in remission for at least 1 year prior to screening
Show all 14Show fewer
- An implanted electrical stimulation device(s) or if the subject is expected to require one of these during the course of the study
- Planned to enroll or is currently enrolled in another investigational drug or investigational medical device study or has participated in an investigational drug or medical device study within 30 days prior to Screening
- Prior to Randomization, a subject will be excluded if:
- Diary does not meet compliance
- Mean diary-reported 12-hour NPRS < 6 (on 0 to 10 scale, as reported over 5 days)
- Positive urine test for alcohol at Baseline
- Negative urine test for opioids at Baseline
- Baseline sleep study (PSG) with SaO2 <=80% for >= 5 consecutive minutes, and/or an Apnea-Hypopnea Index (AHI) >=15.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Virginia Pain Management Center
Charlottesville, Virginia, 22908-0710
Pain Management Services PC
Homewood, Alabama, 35209
Napa Pain Institute and Neurovations
Napa, California, 94558
Compass Research
Orlando, Florida, 32806
IPM Medical Group (Interventional Pain Medical Group)
Walnut Creek, California, 94598
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: Post-market Study Evaluating a Treatment Conversion to Low Dose Intrathecal Morphine From Conventional Medical Management for Maintenance of Pain Control and Improvement of Opioid-related Side Effects. (CONVERT Targeted Drug Delivery [TDD])
This study compares two different ways to treat pain. The two ways are:
- continuing to take current pain medication(s) or
- receiving morphine, a pain medication from a drug pump (a system to deliver drug to your body) that is implanted.
None of the procedures or products used in this study are experimental. The length the study will be about 25 weeks (between 5½ to 6½ months). The purpose of this study is to compare pain and opioid side effects between people who get a drug pump and people who do not get a drug pump that will stay on their current pain medication treatment.
Read the detailed description
This was a randomized, controlled, open-label, multi-center, prospective post-market study to assess pain control and opioid-related side effects following a route of delivery change to low dose IT morphine therapy from systemic opioid therapy. Subjects with nonmalignant, chronic, intractable pain who were experiencing inadequate pain relief and/or intolerable side effects from systemic opioid therapy receiving ≤300 mg/day morphine equivalent dose were eligible for screening. Additionally, the subjects had no known history of sleep apnea and were candidates for IT morphine administration via the SynchroMed Infusion System. Subjects must not have previously undergone an intrathecal/epidural trial for pump infusion therapy.
- Conditions
- Chronic Pain
- Being tested
- SynchroMed Infusion System and Intrathecal Morphine Sulfate, Conventional Medicine
- Keywords
- chronic pain, inadequate pain relief, intolerable side effects
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynchroMed Infusion System and Intrathecal Morphine SulfateDevice
Also called SynchroMed infusion system, Intrathecal morphine sulfate, Infumorph, Targeted drug delivery
Following a successful test of Intrathecal Morphine Sulfate, subjects will undergo surgery to implant the drug pump (SynchroMed Infusion System) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control.
Conventional MedicineOther
Also called Standard of Care
Subjects will continue to use pain medications as prescribed by their doctor.
| Study group | Role | What they receive |
|---|---|---|
| IT group (Intrathecal Morphine Sulfate) | Other | SynchroMed Infusion System and Intrathecal Morphine Sulfate Receives: Device: SynchroMed Infusion System and Intrathecal Morphine Sulfate |
| Conventional Medical Management | Other | Conventional Medicine, and then SynchroMed Infusion System and Intrathecal Morphine Sulfate Receives: Device: SynchroMed Infusion System and Intrathecal Morphine Sulfate; Other: Conventional Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
Determine the proportion of subjects with clinical success based on changes in pain intensity (Numerical Pain Rating Scale: NPRS) and opioid-related Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute (NCI).
Measured: 3 Month
Secondary outcomes (2)
Pain Assessment
Compare changes from Baseline to Month 3 between the IT group and CMM group in Numeric Pain Rating Scale (NPRS). The scale measures pain intensity. Using NPRS, a pain score ranging from 0 (no pain) to 10 (pain as bad as you can imagine) is recorded on a subject diary twice daily for 5 days before a study visit. The score for each visit is calculated as the mean pain of the 5 diary days morning and evening scores. For each subject, the change in pain will be calculated as the mean pain score at Month 3 minus the mean pain score at Baseline. A negative change value represents a lowering of the pain score (an improvement, or reduction in pain).
Measured: 3 Month
Opioid-Related Side Effects
Summarize the changes from Baseline to Month 3 between the IT group and CMM group in Common Terminology Criteria for Adverse Events (CTCAE) toxicity score. (from the National Cancer Institute) A subset of 23 specific items of the CTCAE v4.03 were evaluated. The subset was chosen as these criteria were most related to opioid side effects that are of interest in this study. The investigator scored the assessment at each visit. The total score for a visit is based on the sum of 23 individual CTCAE's. The individual scales have a range of 0 to 2, 0 to 3, or 0 to 5 and the total score ranges from 0 (best case) to 90 (worst case). For each subject, the change in toxicity will be calculated as the total toxicity score at Month 3 minus the total toxicity score at Baseline. A negative change value represents a lowering of the subjects toxicity score (an improvement, or reduction in toxicity).
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Amendment changes were significant enough to warrant a new study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CONVERT TDD Clinical Research Study Team, Study director, MedtronicNeuro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924182
- Sponsor's protocol ID
- 1664 - CONVERT-TDD
- Acronym
- CONVERT-TDD
- Status last verified
- Feb 2018
- First submitted
- 13 Aug 2013
- Last updated
- 29 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Study Evaluating a Treatment Conversion to Low Dose Intrathecal Morphine From Conventional Medical Management for Maintenance of Pain Control and Improvement of Opioid-related Side Effects. (CONVERT Targeted Drug Delivery [TDD])
- ClinicalTrials.gov ID
- NCT01924182
- Acronym / sponsor ID
- CONVERT-TDD / 1664 - CONVERT-TDD
- Conditions
- Chronic Pain
- Keywords
- chronic pain, inadequate pain relief, intolerable side effects
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Amendment changes were significant enough to warrant a new study.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Aug 2013 (estimated)
- Results
- Posted 7 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares two different ways to treat pain. The two ways are:
- continuing to take current pain medication(s) or
- receiving morphine, a pain medication from a drug pump (a system to deliver drug to your body) that is implanted.
None of the procedures or products used in this study are experimental. The length the study will be about 25 weeks (between 5½ to 6½ months). The purpose of this study is to compare pain and opioid side effects between people who get a drug pump and people who do not get a drug pump that will stay on their current pain medication treatment.
Detailed description
This was a randomized, controlled, open-label, multi-center, prospective post-market study to assess pain control and opioid-related side effects following a route of delivery change to low dose IT morphine therapy from systemic opioid therapy. Subjects with nonmalignant, chronic, intractable pain who were experiencing inadequate pain relief and/or intolerable side effects from systemic opioid therapy receiving ≤300 mg/day morphine equivalent dose were eligible for screening. Additionally, the subjects had no known history of sleep apnea and were candidates for IT morphine administration via the SynchroMed Infusion System. Subjects must not have previously undergone an intrathecal/epidural trial for pump infusion therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IT group (Intrathecal Morphine Sulfate) | Other | Device: SynchroMed Infusion System and Intrathecal Morphine SulfateSynchroMed Infusion System and Intrathecal Morphine Sulfate |
| Conventional Medical Management | Other | Device: SynchroMed Infusion System and Intrathecal Morphine Sulfate, Other: Conventional MedicineConventional Medicine, and then SynchroMed Infusion System and Intrathecal Morphine Sulfate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed and dated Medtronic/IRB approved Informed Consent Form and HIPAA Authorization prior to any study procedures being performed
- Willing and able to attend visits and comply with the study protocol
- Willing and able to abstain from alcohol consumption for the study duration
- At least 18 years of age
- Male or non-pregnant, non-lactating female
Key exclusion criteria (14 listed)
- Psychological or other health conditions, financial, and/or legal concerns (within 3 months prior to Screening) that would interfere with the subject's ability to fulfill the requirements of the protocol as per the investigator's opinion
- A history of alcohol abuse or any illicit drug use within 2 years prior to Screening
- A positive urine test for illicit drugs at Screening (Exception: If subject has a physician's prescription for an illicit drug; for example, medical marijuana)
- Known diagnosis of moderate to severe sleep apnea.
- Prescribed Continuous Positive Airway Pressure (CPAP), Adaptive Servo-Ventilation (ASV) therapy or an oral appliance prescribed for the treatment of moderate to severe sleep apnea (current or previous history)
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 |
|---|---|---|
| SynchroMed Infusion System and Intrathecal Morphine SulfateAlso: SynchroMed infusion system, Intrathecal morphine sulfate, Infumorph, Targeted drug deliveryFollowing a successful test of Intrathecal Morphine Sulfate, subjects will undergo surgery to implant the drug pump (SynchroMed Infusion System) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control. | Device | Conventional Medical Management, IT group (Intrathecal Morphine Sulfate) |
| Conventional MedicineAlso: Standard of CareSubjects will continue to use pain medications as prescribed by their doctor. | Other | Conventional Medical Management |
Primary outcome
Clinical Success
Time frame: 3 Month
Determine the proportion of subjects with clinical success based on changes in pain intensity (Numerical Pain Rating Scale: NPRS) and opioid-related Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute (NCI).
2 secondary outcomes
Pain Assessment
Time frame: 3 Month
Opioid-Related Side Effects
Time frame: 3 Month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
CONVERT TDD Clinical Research Study Team study director
MedtronicNeuro
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SynchroMed Infusion System and Intrathecal Morphine Sulfate and Conventional Medicine in people with Chronic Pain, run by MedtronicNeuro at 6 sites 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 13 inclusion and 14 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 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Yes. Results are posted in the registry (first posted 7 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Success (time frame: 3 Month). 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 29 Mar 2018.