Chronic PainPhase 3NCT01709747
Single-arm Study to Assess the Safety of Hydromorphone Hydrochloride by Intrathecal Administration
A Phase 3 study testing Hydromorphone Hydrochloride and Programmable Implantable pump in people with Chronic Pain, run by Piramal Critical Care, Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the long-term safety of hydromorphone hydrochloride administered by intrathecal delivery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Hydromorphone Hydrochloride and Programmable Implantable pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Feb 2018
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be included:
- Subjects must be at least 18 years of age and no more than 75 years old.
- Clinically diagnosed with severe chronic pain for at least a 6-month period.
- Subject is reasonably expected to benefit from intrathecal pain medication and has a programmable implantable intrathecal pump or meets clinical criteria for implantation of an intrathecal pump per Standard of Care.
- Subject agrees to sign a Pain Treatment Agreement (Narcotic Contract) limiting narcotic prescriptions to the study medication prescribed by the investigator.
- Subject must be cognitively intact and, in the opinion of the investigator, capable of participation in the trial.
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- Female subjects of child-bearing potential must agree to use a medically acceptable and effective double-barrier method of birth control.
- Subjects who can receive an MRI if required by the study protocol.
- Provides written Ethics Committee approved informed consent.
- Willing to comply with all study procedures and requirements.
Who cannot join
- Subjects meeting any of the following criteria will be excluded:
- Women who are pregnant or breast-feeding.
- Subject has any known or suspected allergy to hydromorphone hydrochloride or to the materials of the infusion pump or intrathecal catheter.
- Subject has a history of dependence and abuse of opioids, stimulants, alcohol, or benzodiazepines, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria, within the past year (physical dependence on prescribed opioid analgesics is allowed but abuse of opioids according to DSM-IV is not permitted, i.e. opioid addiction for recreational use).
- Subjects who show signs of active systemic infection.
- Subjects with a metastatic cancer to the spinal canal or a known central nervous system contraindication to intrathecal therapy.
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- Subjects have a condition requiring diathermy procedures.
- Subject has a life expectancy of less than 12 months.
- Subjects who are unable or unwilling to return to all of the required follow-up visits.
- As a result of medical review and physical examination, the Investigator considers the subject unfit for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 3, Open-Label, Single-Arm Study To Assess The Safety Of Hydromorphone Hydrochloride Delivered By Intrathecal Administration
The purpose of this study is to evaluate the long-term safety of hydromorphone hydrochloride administered by intrathecal delivery.
Read the detailed description
This is an open-label, single-arm safety study to evaluate the safety of hydromorphone hydrochloride given by continuous intrathecal infusion using an implantable pump device. This study will enroll both subjects on a current opioid intrathecal medication as well as naïve subjects now current on intrathecal opioid medications. All subjects currently on intrathecal opioid treatment will be converted from their current intrathecal therapy to intrathecal hydromorphone hydrochloride according to standard medical practice. After an optimal dose for pain relief is achieved, subjects will remain on therapy for a total of 12 months or until discontinuation from the study. During this continuous dosing period, dose adjustments (up or down) are permitted to manage pain or side effects provided a maximum dose of 10 mg/day is not exceeded. Subjects will be assessed for pain intensity using a visual analog scale of pain intensity (VASPI) instrument at each study visit.
Subjects will be evaluated for side effects and clinical complications associated with the use of intrathecal hydromorphone. Events will be classified by intrathecal drugs used and concentrations.
- Conditions
- Chronic Pain
- Being tested
- Hydromorphone Hydrochloride, Programmable Implantable pump
- Keywords
- Hydromorphone Hydrochloride, Hydromorphone, Pain, Chronic Pain, Implantable Pump, Pump, Intrathecal
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydromorphone HydrochlorideDrug
Also called Hydromorphone, Opioid
Opioid for chronic pain
Programmable Implantable pumpDevice
Device: Programmable Implantable pump
Programmable Implantable pump delivering intrathecal hydromorphone
| Study group | Role | What they receive |
|---|---|---|
| Hydromorphone Hydrochloride | Experimental | Hydromorphone hydrochloride for intrathecal administration, 12 months safety evaluation Receives: Drug: Hydromorphone Hydrochloride; Device: Programmable Implantable pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Granulomas
Subjects with Clinical Signs and Symptoms of Granuloma [Note: The primary endpoint of this trial is Safety. There is no formal efficacy assessment planned in this open-label safety study.]
Measured: 12 months
Secondary outcomes (3)
Brief Pain Inventory (BPI) - Mean Pain Severity
Change from Baseline in the Brief Pain Inventory (BPI). Pain Severity Measures, Scale: 0 = No Pain, 10 = Pain as bad as you can imagine; a high score indicates a worse outcome. Therefore, a negative change from baseline indicates a better outcome. Outcome is Mean Pain Severity score calculated as the arithmetic mean of the Worst, Least, Average and Now scores. A negative change indicates better outcome.
Measured: Early Termination/Final Visit through 12 months
Patient Global Impression of Change (PGIC)
Change from Baseline in the Patient Global Impression of Change (PGIC). Scale: 7-point Likert scale, from 1 = No Change through 7 = A great deal better; a high score indicates a better outcome. Therefore, a positive change from baseline indicates a better outcome.
Measured: Early Termination/Final Visit through 12 months
Visual Analog Scale Pain Intensity (VASPI)
Change from Baseline in Visual Analog Scale Pain Intensity (VASPI). Scale: 0 mm = No Pain, 100 mm = Unbearable Pain; high score is worse. Therefore, a negative change from baseline indicates a better outcome.
Measured: Early Termination/Final Visit through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startJun 2013
- Primary completionFeb 2018
- Study completionFeb 2018
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piramal Critical Care, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Rauck, MD, Principal investigator, Carolinas Pain Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709747
- Sponsor's protocol ID
- CNS-HYD202US
- Status last verified
- Aug 2021
- First submitted
- 4 Sep 2012
- Last updated
- 25 Aug 2021
- 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 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-Label, Single-Arm Study To Assess The Safety Of Hydromorphone Hydrochloride Delivered By Intrathecal Administration
- ClinicalTrials.gov ID
- NCT01709747
- Acronym / sponsor ID
- CNS-HYD202US
- Conditions
- Chronic Pain
- Keywords
- Hydromorphone Hydrochloride, Hydromorphone, Pain, Chronic Pain, Implantable Pump, Pump, Intrathecal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Piramal Critical Care, Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2013 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Posted 25 Aug 2021
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 evaluate the long-term safety of hydromorphone hydrochloride administered by intrathecal delivery.
Detailed description
This is an open-label, single-arm safety study to evaluate the safety of hydromorphone hydrochloride given by continuous intrathecal infusion using an implantable pump device. This study will enroll both subjects on a current opioid intrathecal medication as well as naïve subjects now current on intrathecal opioid medications. All subjects currently on intrathecal opioid treatment will be converted from their current intrathecal therapy to intrathecal hydromorphone hydrochloride according to standard medical practice. After an optimal dose for pain relief is achieved, subjects will remain on therapy for a total of 12 months or until discontinuation from the study. During this continuous dosing period, dose adjustments (up or down) are permitted to manage pain or side effects provided a maximum dose of 10 mg/day is not exceeded. Subjects will be assessed for pain intensity using a visual analog scale of pain intensity (VASPI) instrument at each study visit.
Subjects will be evaluated for side effects and clinical complications associated with the use of intrathecal hydromorphone. Events will be classified by intrathecal drugs used and concentrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydromorphone Hydrochloride | Experimental | Drug: Hydromorphone Hydrochloride, Device: Programmable Implantable pumpHydromorphone hydrochloride for intrathecal administration, 12 months safety evaluation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects must be at least 18 years of age and no more than 75 years old.
- Clinically diagnosed with severe chronic pain for at least a 6-month period.
- Subject is reasonably expected to benefit from intrathecal pain medication and has a programmable implantable intrathecal pump or meets clinical criteria for implantation of an intrathecal pump per Standard of Care.
- Subject agrees to sign a Pain Treatment Agreement (Narcotic Contract) limiting narcotic prescriptions to the study medication prescribed by the investigator.
- Subject must be cognitively intact and, in the opinion of the investigator, capable of participation in the trial.
Key exclusion criteria (10 listed)
- Women who are pregnant or breast-feeding.
- Subject has any known or suspected allergy to hydromorphone hydrochloride or to the materials of the infusion pump or intrathecal catheter.
- Subject has a history of dependence and abuse of opioids, stimulants, alcohol, or benzodiazepines, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria, within the past year (physical dependence on prescribed opioid analgesics is allowed but abuse of opioids according to DSM-IV is not permitted, i.e. opioid addiction for recreational use).
- Subjects who show signs of active systemic infection.
- Subjects with a metastatic cancer to the spinal canal or a known central nervous system contraindication to intrathecal therapy.
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 |
|---|---|---|
| Hydromorphone HydrochlorideAlso: Hydromorphone, OpioidOpioid for chronic pain | Drug | Hydromorphone Hydrochloride |
| Programmable Implantable pumpDevice: Programmable Implantable pump Programmable Implantable pump delivering intrathecal hydromorphone | Device | Hydromorphone Hydrochloride |
Primary outcome
Granulomas
Time frame: 12 months
Subjects with Clinical Signs and Symptoms of Granuloma [Note: The primary endpoint of this trial is Safety. There is no formal efficacy assessment planned in this open-label safety study.]
3 secondary outcomes
Brief Pain Inventory (BPI) - Mean Pain Severity
Time frame: Early Termination/Final Visit through 12 months
Patient Global Impression of Change (PGIC)
Time frame: Early Termination/Final Visit through 12 months
Visual Analog Scale Pain Intensity (VASPI)
Time frame: Early Termination/Final Visit through 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- 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.
Richard Rauck, MD principal investigator
Carolinas Pain Institute
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 Hydromorphone Hydrochloride and Programmable Implantable pump in people with Chronic Pain, run by Piramal Critical Care, Ltd. 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 10 inclusion and 10 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: finished, as of the sponsor's last update on 25 Aug 2021. 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.
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?
Yes. Results are posted in the registry (first posted 25 Aug 2021). 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?
Granulomas (time frame: 12 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 25 Aug 2021.