Clinical trial NCT01709721: Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Management of Chronic Pain
Keywords: Hydromorphone
Hydromorphone Hydrochloride
Pain Management
Non-narcotic analgesics
Lead sponsor: Piramal Critical Care, Ltd.
Sponsor class: INDUSTRY
First posted: 2012-10-18
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following criteria to be included:

1. Subject must be at least 18 years of age and no more than 75 years old.
2. Clinically diagnosed with chronic pain for at least a 6-month period.
3. 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.
4. Subject agrees to sign a Pain Treatment Agreement (Narcotic Contract) limiting narcotic prescriptions to the study physician.
5. Subject must be cognitively intact and, in the opinion of the investigator, capable of participation in the trial.
6. Female subjects of child-bearing potential must agree to use a medically acceptable and effective double-barrier method of birth control.
7. Subjects with existing SynchroMed II Implantable pumps and are reasonably expected to benefit from intrathecal opioid therapy only.
8. Subjects who are capable of receiving an MRI with or without contrast or CT myelogram, if required by the study protocol.
9. Provides written Ethics Committee approved informed consent.
10. Willing to comply with all study procedures and requirements..

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded:

1. Women who are pregnant or are breast-feeding
2. Subjects who have participated in an investigational drug or device trial within 4 weeks prior to enrollment.
3. Subject has any known or suspected allergy to hydromorphone or to the materials of the infusion pump or intrathecal catheter.
4. Subject is scheduled for a pump or catheter replacement within 6 months of their enrollment into the trial.
5. 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).
6. Subjects who show signs of active systemic infection.
7. Subjects with a metastatic cancer to the spinal canal or a known central nervous system contraindication to intrathecal therapy.
8. Subject has a condition requiring diathermy procedures.
9. Subject has a life expectancy of less than 12 months.
10. 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.
11. Subject is not considered to be medically or psychologically appropriate for pump implantation.
12. Subjects who are unable or unwilling to return to all of the required follow-up visits.
13. 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.
14. As a result of medical review and physical examination, the Investigator considers the subject unfit for the study.
15. 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.
16. Subjects who have previously been unresponsive to intrathecal hydromorphone therapy.

Primary outcomes:
measure: Proportion of Subjects Who Are Treatment Failures During the Double-blind Randomized Withdrawal Period
timeFrame: 5 weeks [Baseline (Day 84) to Day 119 Visit]
Secondary outcomes:
measure: Brief Pain Inventory (BPI): Pain Severity, "Worst"
timeFrame: 5 Weeks [Baseline (Day 84) to Day 119 Visit]
measure: Brief Pain Inventory (BPI): Pain Severity "Average"
timeFrame: 5 Weeks [Baseline (Day 84) to Day 119]
measure: Brief Pain Inventory (BPI): Pain Severity Summary Measure
timeFrame: 5 Weeks [Baseline (Day 84) to Day 119]
measure: Brief Pain Inventory: Interference With Function Summary Measure
timeFrame: 5 Weeks [Baseline (Day 84) to Day 119]
measure: Short-Form McGill Pain Questionnaire (SF-MPQ): Summary Score
timeFrame: 5 Weeks [Baseline (Day 84) to Day 119]
measure: Time to Rescue Medication After Randomization (Days)
timeFrame: 5 Weeks [Baseline (Day 84) to Day 119]
measure: Patient Global Impression of Change (PGIC)
timeFrame: 5 Weeks [Baseline (Day 84) to Day 119 / Treatment Failure]
measure: Oral Opioid Supplement Consumption
timeFrame: 5 Weeks [Baseline (Day 84) to Day 119]
measure: Time to Rescue - Rescue Medication Given
timeFrame: 5 Weeks [Baseline (Day 84) to Day 119]
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
Study officials:
affiliation: The Center for Clinical Research
name: Richard L Rauck, MD
role: PRINCIPAL_INVESTIGATOR
References: