Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration

• ClinicalTrials.gov Identifier: NCT01709721
• Recruitment Status: Completed
• First Posted: October 18, 2012
• Last Update Posted: May 3, 2019
• Sponsor: Piramal Critical Care, Ltd.
• Information provided by (Responsible Party): Piramal Critical Care, Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Management of Chronic Pain	Drug: Hydromorphone Hydrochloride; Device: Programmable Implantable pump	Phase 3

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: February 2013
• Actual Primary Completion Date: February 2018
• Actual Study Completion Date: February 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Active; Subjects on hydromorphone hydrochloride for the duration of therapy.	Drug: Hydromorphone Hydrochloride; Opioid for chronic pain; Other Names: Hydromorphone; Opioid; Device: Programmable Implantable pump; Programmable Implantable pump delivering intrathecal hydromorphone
Active Comparator: Titrated off therapy; Subjects on control	Drug: Hydromorphone Hydrochloride; Opioid for chronic pain; Other Names: Hydromorphone; Opioid; Device: Programmable Implantable pump; Programmable Implantable pump delivering intrathecal hydromorphone

Outcome Measures

Primary Outcome Measures :

1. Superiority of intrathecal hydromorphone hydrochloride as compared to a control arm. [ Time Frame: 4 weeks ]
   The primary efficacy endpoint is the proportion of subjects who are treatment failures during the double-blind randomized withdrawal period. A subject who experiences an increase of 20 mm or more points on a 100 mm visual analog scale of pain intensity, based on a 3-day average, or who experiences intolerable pain that requires intervention, will be considered a treatment failure

Secondary Outcome Measures :

1. Functionality based on a Brief Pain Inventory [ Time Frame: 18 weeks ]
   Patients ability to function and perform tasks without significant pain based on the brief pain inventory scale.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, North Carolina

The Center for Clinical Research

Winston-Salem, North Carolina, United States, 27103

Sponsors and Collaborators

Piramal Critical Care, Ltd.

Investigators

• Principal Investigator: Richard L Rauck, MD; The Center for Clinical Research

  Study Documents (Full-Text)

Documents provided by Piramal Critical Care, Ltd.:

Study Protocol  [PDF] August 1, 2016

Statistical Analysis Plan  [PDF] February 4, 2019

More Information

• Responsible Party: Piramal Critical Care, Ltd.
• ClinicalTrials.gov Identifier: NCT01709721
• Other Study ID Numbers: CNS-HYD201US
• First Posted: October 18, 2012
• Last Update Posted: May 3, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Piramal Critical Care, Ltd.:

Hydromorphone; Hydromorphone Hydrochloride; Pain Management; Non-narcotic analgesics

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations; Hydromorphone; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents