Post-market, Randomized, Controlled, Prospective Study Evaluating Intrathecal Pain Medication (IT) Versus Conventional Medical Management (CMM) in the Non-cancer, Refractory, Chronic Pain Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-05

Study Completion Date

2022-04-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is being conducted to compare intrathecal morphine using the commercially available intrathecal drug delivery systems (IDDS), and conventional medical management (CMM) in subjects with non-cancer, refractory chronic pain.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prometra's Utilization in Mitigating Pain II

NCT00866164

Intractable Pain Back Pain Leg Pain +2 more

APPROVED_FOR_MARKETING

Intrathecal Morphine Compared to Conventional Medical Management for Pain Control and Opioid-related Side Effects

NCT01924182

Chronic Pain

TERMINATED NA

Prometra's Utilization in Mitigating Pain (PUMP)

NCT00817596

Intractable Pain

COMPLETED NA

The Clinical Evaluation of Implantable Pump System For Safety And Delivery Accuracy In Patients Requiring Intrathecal Administration Of Morphine Sulfate For Chronic Pain

NCT01185470

Cancers Chronic Pain

COMPLETED PHASE2/PHASE3

Prometra Post-Approval Study

NCT01854229

Chronic Pain Cancer Pain Intractable Pain +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will evaluate the following objectives:

Primary objective:

1\. To compare the change in pain intensity from baseline based on the Numeric Rating Scale \[NRS\] between subjects randomized to the IDDS group and subjects randomized to the CMM group.The comparison will be conducted at 3, 6, 9 and 12 months following enrollment. The evaluation at 6 months will be considered the primary time point for evaluation.

Secondary objectives:

For each of the following secondary objectives, the comparisons between the IDDS group and CMM group will be made using the intra-subject change from baseline as the dependent variable.

1. Compare the subject reported PROMIS 29 between the IDDS group and CMM group. Individual subject scores recorded at baseline and months 3, 6, 9 and 12.
2. Compare the accrued cost of therapy for pain control including those related to adverse events, ED visits, cost of medications between the IDDS group and CMM group
3. Compare the number of other concurrent treatments performed on each subject between the IDDS group and CMM group. Individual subject counts recorded at months 3, 6, 9 and 12 will be compared.

Additional safety objective:

1\. To characterize pain and device related adverse events for all subjects throughout the study through completion of 12 month follow-up or subject exit.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Nonmalignant Pain Pain, Intractable Pain, Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized in a 1:1 ratio to one of two groups

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intrathecal Drug Delivery System

Subjects randomized to the Intrathecal Drug Delivery System group will be implanted with the Prometra System under sterile technique in accordance with the Instructions for Use. The pump will be filled at the time of implantation with the prescribed medication.

Group Type ACTIVE_COMPARATOR

Flowonix Prometra® II Programmable Infusion System

Intervention Type DEVICE

The Flowonix Prometra® II Programmable Infusion System consists of an implanted infusion pump and catheter, and external components including a clinician programmer, refill and catheter access port kits, the PTC™(a subject operated controller).

Conventional Medical Management

Subjects randomized to the Conventional Medical Management group will continue with the standard of care procedures.

Group Type ACTIVE_COMPARATOR

Pain Medicine

Intervention Type DRUG

Injections, spinal cord stimulation, peripheral nerve stimulation, pain medication, etc.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Flowonix Prometra® II Programmable Infusion System

The Flowonix Prometra® II Programmable Infusion System consists of an implanted infusion pump and catheter, and external components including a clinician programmer, refill and catheter access port kits, the PTC™(a subject operated controller).

Intervention Type DEVICE

Pain Medicine

Injections, spinal cord stimulation, peripheral nerve stimulation, pain medication, etc.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Systemic opioid therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subject must have signed and dated the IRB approved Informed Consent Form and HIPAA Authorization prior to any study procedures being performed
2. Subject must be willing and able to complete study requirements including diaries, questionnaires and attend all visits, in the opinion of the investigator
3. Subject must be male or female and at least 22 years of age
4. Subjects who are female are non-lactating and if of childbearing potential have a negative urine pregnancy test at screening
5. Subjects who are currently be receiving ≤ 90 mg/day morphine per day dose (or MME), with stable dose at equivalent of systemic opioids at Screening
6. Subjects who are on a stable dose of opioids (no change in type or prescribed frequency or dose) for 30 days prior to the screening as documented in medical history;
7. Subjects who have refractory pain despite failure of regional minimally invasive treatment options, including epidurals, facets, rhizotomies, direct or indirect spinal stenosis treatments, etc.
8. Subjects who are a new candidate for chronic intrathecal drug therapy (including no prior intrathecal/epidural trial for pump infusion therapy)
9. Subjects have not been implanted with a spinal cord stimulator for pain
10. Subjects currently do not have an implanted spinal cord stimulator for pain
11. Subjects who have a diagnosis of nonmalignant, chronic intractable pain as documented in the medical history
12. Subjects who are medically stable and able to undergo surgery for implantation of the Prometra® II Infusion System
13. Subject must have completed a psychological evaluation within 6 months prior to Screening
14. Subject must complete an intrathecal trial resulting in candidacy for pump implantation during Screening

Exclusion Criteria

A potential subject who has any contraindications listed in the Prometra® II labeling or any contraindications of intrathecal agents employed in the United States within the PACC, will be excluded. All subjects meeting any of the following criteria will also be excluded from this study:

1. Subjects currently have a spinal cord stimulator implanted for pain
2. Subjects previously had a spinal cord stimulator implanted for pain
3. Subjects who have 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
4. Subjects who have a history of alcohol abuse or illicit drug use within 2 years of screening
5. Subjects who have an active malignancy or has been diagnosed with cancer and has not been in remission for at least 1 year prior to Screening
6. Subjects who are female and who are pregnant, nursing or planning a pregnancy during the study or females of childbearing potential who are unable or unwilling to use a form of contraception during the study.
7. Subjects who plan 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
8. Subject has any condition or situation which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study

At the Baseline Visit or prior to Randomization, a subject will be excluded from continued participation if the subject has:
9. Subjects that have a mean of the reported 12 hour "average" NPRS responses of \< 6 on an eleven-point scale (0 to10) rated over the 5 days prior to the Baseline Visit (as recorded in the electronic Study Diary) in the absence of intolerable side effects as documented in the medical history
10. Subjects with a negative urine test for opioids at Baseline
11. Subjects with a positive Pregnancy test, if applicable
12. Subjects that failed the intrathecal trial during Screening

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No