Management of Chronic PainPhase 3NCT01709721
Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration
A Phase 3 study testing Hydromorphone Hydrochloride and Programmable Implantable pump in people with Management of Chronic Pain, run by Piramal Critical Care, Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of hydromorphone hydrochloride by intrathecal administration using a programmable implantable pump. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Management of 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
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 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:
- Subject must be at least 18 years of age and no more than 75 years old.
- Clinically diagnosed with chronic pain for at least a 6-month period.
- Subject is presently on intrathecal pain medication and has a SynchroMed II Implantable pump or meets clinical criteria for implantation of a SynchroMed II Implantable pump. Subjects who are naïve to intrathecal therapy, may be enrolled 2-weeks after pump implantation.
- Subject agrees to sign a Pain Treatment Agreement (Narcotic Contract) limiting narcotic prescriptions to the study physician.
- 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 with existing SynchroMed II Implantable pumps and are reasonably expected to benefit from intrathecal opioid therapy only.
- Subjects who are capable of receiving an MRI with or without contrast or CT myelogram, 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 are breast-feeding
- Subjects who have participated in an investigational drug or device trial within 4 weeks prior to enrollment.
- Subject has any known or suspected allergy to hydromorphone or to the materials of the infusion pump or intrathecal catheter.
- Subject is scheduled for a pump or catheter replacement within 6 months of their enrollment into the trial.
- Subject has a history of dependence and abuse of opioids, stimulants, alcohol, or benzodiazepines, as defined by 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).
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- 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.
- Subject has a condition requiring diathermy procedures.
- Subject has a life expectancy of less than 12 months.
- Subject cannot independently comprehend and participate in the required assessments, including responding to the VASPI, Short-form McGill Pain Questionnaire (SF-MPQ), Clinical Opiate Withdrawal Scale (COWS), Subjective Opiate Withdrawal Scale (SOWS), BPI and patient global impression of change (PGIC) measurement tools.
- Subject is not considered to be medically or psychologically appropriate for pump implantation.
- Subjects who are unable or unwilling to return to all of the required follow-up visits.
- Subjects with active implanted devices such as pacemakers, defibrillators, and cochlear implants or other medical device use, if in the opinion of the investigator the device would interfere with the ability to perform an MRI or CT myelogram.
- As a result of medical review and physical examination, the Investigator considers the subject unfit for the study.
- Pain located above the shoulders in the head or neck region (e.g. trigeminal neuralgia), central pain syndromes or any other condition in which it is judged to be unlikely that the subject would benefit from intrathecal administration of the drug product.
- Subjects who have previously been unresponsive to intrathecal hydromorphone therapy.
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 Controlled, Two-Arm, Parallel Group, Randomized Withdrawal Study to Assess the Safety and Efficacy of Hydromorphone Hydrochloride Delivered by Intrathecal Administration Using a Programmable Implantable Pump
The purpose of this study is to determine the safety and efficacy of hydromorphone hydrochloride by intrathecal administration using a programmable implantable pump.
Read the detailed description
A Controlled, Two-Arm, Parallel Group, Randomized Withdrawal Study to Assess the Safety and Efficacy of Hydromorphone Hydrochloride Delivered by Intrathecal Administration Using a Programmable Implantable Pump
- Conditions
- Management of Chronic Pain
- Being tested
- Hydromorphone Hydrochloride, Programmable Implantable pump
- Keywords
- Hydromorphone, Hydromorphone Hydrochloride, Pain Management, Non-narcotic analgesics
- Medical subject headings
- Agnosia
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
Programmable Implantable pump delivering intrathecal hydromorphone
| Study group | Role | What they receive |
|---|---|---|
| Hydromorphone Hydrochloride (Randomized/Double-Blind) | Experimental | Subjects on hydromorphone hydrochloride for the duration of therapy. Receives: Drug: Hydromorphone Hydrochloride; Device: Programmable Implantable pump |
| Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind) | Active comparator | Subjects on hydromorphone hydrochloride titrated downward 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.
Proportion of Subjects Who Are Treatment Failures During the Double-blind Randomized Withdrawal Period
Treatment failure during the Randomized Phase is defined as at least one of the following: a) increase of >= 20mm VASPI vs. baseline over 5 days; b) intolerable pain that in investigator's opinion requires intervention; or c) pain-related interventions that violate protocol from Day 84 to Day 119.
Note: Baseline pain for the randomized phase is defined as the average of the last 5 days with daily pain measurements while on an optimal intrathecal dose of Hydromorphone, between Days 77 and 83 of the open label dosing period.
Note: A subject who does not have sufficient data for evaluation, drops out for any other reasons that are not listed above or who experiences withdrawal syndrome as identified by COWS > 12 during the randomized phase will not be classified as a treatment failure.
Note: Analysis period is from beginning of randomization phase (Day 84) to end of study.
Measured: 5 weeks [Baseline (Day 84) to Day 119 Visit]
Secondary outcomes (9)
Brief Pain Inventory (BPI): Pain Severity, "Worst"
'Worst' pain experienced in the past 24 hours. Brief Pain Inventory (BPI): Scale: 0 = No Pain, 10 = Pain as bad as you can imagine; a high score indicates a worse outcome.
Measured: 5 Weeks [Baseline (Day 84) to Day 119 Visit]
Brief Pain Inventory (BPI): Pain Severity "Average"
'Average' pain experienced in the past 24 hours. The Brief Pain Inventory (BPI): Scale: 0 = No Pain, 10 = Pain as bad as you can imagine; a high score indicates a worse outcome.
Measured: 5 Weeks [Baseline (Day 84) to Day 119]
Brief Pain Inventory (BPI): Pain Severity Summary Measure
Pain severity will be evaluated by rating pain on a scale from 0 (no pain) to 10 (pain as bad as you can imagine) for the 'worst', 'least', and 'average' pain experienced in the past 24 hours, as well as, the pain experienced 'now'. In addition, a calculated mean pain severity score will be based on the sum of all 4 of the pain scores divided by 4. If any of the 4 questions are missing, then the calculated mean pain severity score will be considered missing. High values indicate worse outcome.
Measured: 5 Weeks [Baseline (Day 84) to Day 119]
Brief Pain Inventory: Interference With Function Summary Measure
Pain interference with daily functioning will be evaluated by rating interference on a scale from 0 (does not interfere) to 10 (completely interferes) for 'general activity', 'mood', 'walking ability', 'normal work', 'relation with other people', 'sleep', and 'enjoyment of life'. A calculated mean pain interference will be based on the sum of non-missing interference questions answered divided by the number of questions answered. The mean should be set to missing if fewer than 4 pain interference questions are answered. A high score is worse.
Measured: 5 Weeks [Baseline (Day 84) to Day 119]
Short-Form McGill Pain Questionnaire (SF-MPQ): Summary Score
The SF-MPQ consists of a 15 item pain rating index. The severity of each item will be scored as None (0), Mild (1), Moderate (2), or Severe (3). The total SF-MPQ score is the sum of the severity scores for each item. The total score can range from 0 to 45; high score is worse.
Measured: 5 Weeks [Baseline (Day 84) to Day 119]
Time to Rescue Medication After Randomization (Days)
The number of days to rescue will be calculated by calculating the number of hours between the time of randomization and the time of rescue. The number of hours will then be divided by 24 to obtain the number of days.
Measured: 5 Weeks [Baseline (Day 84) to Day 119]
Patient Global Impression of Change (PGIC)
The PGIC rating represents observed changes (if any) from the subject's Baseline Visit in activity limitations, symptoms, emotions, and overall quality of life, related to the subject's painful condition. Change is rated on a 7-point Likert-type scale from 1 (no change) through 7 (a great deal better). High score is better outcome.
Measured: 5 Weeks [Baseline (Day 84) to Day 119 / Treatment Failure]
Oral Opioid Supplement Consumption
Total consumption (mg) = The total number of milligrams consumed of any oral opioid product from Day 84 (Baseline) through the end of study will be calculated for each subject.
Measured: 5 Weeks [Baseline (Day 84) to Day 119]
Time to Rescue - Rescue Medication Given
Number of subjects with rescue medication given
Measured: 5 Weeks [Baseline (Day 84) to Day 119]
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 startFeb 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 Management of 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piramal Critical Care, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard L Rauck, MD, Principal investigator, The Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709721
- Sponsor's protocol ID
- CNS-HYD201US
- Status last verified
- Oct 2021
- First submitted
- 24 Aug 2012
- Last updated
- 4 Nov 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 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Two-Arm, Parallel Group, Randomized Withdrawal Study to Assess the Safety and Efficacy of Hydromorphone Hydrochloride Delivered by Intrathecal Administration Using a Programmable Implantable Pump
- ClinicalTrials.gov ID
- NCT01709721
- Acronym / sponsor ID
- CNS-HYD201US
- Conditions
- Management of Chronic Pain
- Keywords
- Hydromorphone, Hydromorphone Hydrochloride, Pain Management, Non-narcotic analgesics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Piramal Critical Care, Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2013 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Posted 17 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 determine the safety and efficacy of hydromorphone hydrochloride by intrathecal administration using a programmable implantable pump.
Detailed description
A Controlled, Two-Arm, Parallel Group, Randomized Withdrawal Study to Assess the Safety and Efficacy of Hydromorphone Hydrochloride Delivered by Intrathecal Administration Using a Programmable Implantable Pump
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydromorphone Hydrochloride (Randomized/Double-Blind) | Experimental | Drug: Hydromorphone Hydrochloride, Device: Programmable Implantable pumpSubjects on hydromorphone hydrochloride for the duration of therapy. |
| Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind) | Active comparator | Drug: Hydromorphone Hydrochloride, Device: Programmable Implantable pumpSubjects on hydromorphone hydrochloride titrated downward |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject must be at least 18 years of age and no more than 75 years old.
- Clinically diagnosed with chronic pain for at least a 6-month period.
- Subject is presently on intrathecal pain medication and has a SynchroMed II Implantable pump or meets clinical criteria for implantation of a SynchroMed II Implantable pump. Subjects who are naïve to intrathecal therapy, may be enrolled 2-weeks after pump implantation.
- Subject agrees to sign a Pain Treatment Agreement (Narcotic Contract) limiting narcotic prescriptions to the study physician.
- Subject must be cognitively intact and, in the opinion of the investigator, capable of participation in the trial.
Key exclusion criteria (17 listed)
- Women who are pregnant or are breast-feeding
- Subjects who have participated in an investigational drug or device trial within 4 weeks prior to enrollment.
- Subject has any known or suspected allergy to hydromorphone or to the materials of the infusion pump or intrathecal catheter.
- Subject is scheduled for a pump or catheter replacement within 6 months of their enrollment into the trial.
- Subject has a history of dependence and abuse of opioids, stimulants, alcohol, or benzodiazepines, as defined by 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).
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 (Randomized/Double-Blind), Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind) |
| Programmable Implantable pumpProgrammable Implantable pump delivering intrathecal hydromorphone | Device | Hydromorphone Hydrochloride (Randomized/Double-Blind), Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind) |
Primary outcome
Proportion of Subjects Who Are Treatment Failures During the Double-blind Randomized Withdrawal Period
Time frame: 5 weeks [Baseline (Day 84) to Day 119 Visit]
Treatment failure during the Randomized Phase is defined as at least one of the following: a) increase of >= 20mm VASPI vs. baseline over 5 days; b) intolerable pain that in investigator's opinion requires intervention; or c) pain-related interventions that violate protocol from Day 84 to Day 119. Note: Baseline pain for the randomized phase is defined as the average of the last 5 days with daily pain measurements while on an optimal intrathecal dose of Hydromorphone, between Days 77 and 83 of the open label dosing period. Note: A subject who does not have sufficient data for evaluation, drops out for any other reasons that are not listed above or who experiences withdrawal syndrome as identified by COWS > 12 during the randomized phase will not be classified as a treatment failure. Note: Analysis period is from beginning of randomization phase (Day 84) to end of study.
9 secondary outcomes
Brief Pain Inventory (BPI): Pain Severity, "Worst"
Time frame: 5 Weeks [Baseline (Day 84) to Day 119 Visit]
Brief Pain Inventory (BPI): Pain Severity "Average"
Time frame: 5 Weeks [Baseline (Day 84) to Day 119]
Brief Pain Inventory (BPI): Pain Severity Summary Measure
Time frame: 5 Weeks [Baseline (Day 84) to Day 119]
Brief Pain Inventory: Interference With Function Summary Measure
Time frame: 5 Weeks [Baseline (Day 84) to Day 119]
Short-Form McGill Pain Questionnaire (SF-MPQ): Summary Score
Time frame: 5 Weeks [Baseline (Day 84) to Day 119]
Time to Rescue Medication After Randomization (Days)
Time frame: 5 Weeks [Baseline (Day 84) to Day 119]
Patient Global Impression of Change (PGIC)
Time frame: 5 Weeks [Baseline (Day 84) to Day 119 / Treatment Failure]
Oral Opioid Supplement Consumption
Time frame: 5 Weeks [Baseline (Day 84) to Day 119]
Time to Rescue - Rescue Medication Given
Time frame: 5 Weeks [Baseline (Day 84) to Day 119]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 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 L Rauck, MD principal investigator
The Center for Clinical Research
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 Management of 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 11 inclusion and 17 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 4 Nov 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 17 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?
Proportion of Subjects Who Are Treatment Failures During the Double-blind Randomized Withdrawal Period (time frame: 5 weeks [Baseline (Day 84) to Day 119 Visit]). 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 4 Nov 2021.