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Single-arm Study to Assess the Safety of Hydromorphone Hydrochloride by Intrathecal Administration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01709747
Recruitment Status : Completed
First Posted : October 18, 2012
Results First Posted : August 25, 2021
Last Update Posted : August 25, 2021
Information provided by (Responsible Party):
Piramal Critical Care, Ltd.

Brief Summary:
The purpose of this study is to evaluate the long-term safety of hydromorphone hydrochloride administered by intrathecal delivery.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 364 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label, Single-Arm Study To Assess The Safety Of Hydromorphone Hydrochloride Delivered By Intrathecal Administration
Actual Study Start Date : June 2013
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Hydromorphone Hydrochloride
Hydromorphone hydrochloride for intrathecal administration, 12 months safety evaluation
Drug: Hydromorphone Hydrochloride
Opioid for chronic pain
Other Names:
  • Hydromorphone
  • Opioid

Device: Programmable Implantable pump

Device: Programmable Implantable pump

Programmable Implantable pump delivering intrathecal hydromorphone

Primary Outcome Measures :
  1. 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.]

Secondary Outcome Measures :
  1. Brief Pain Inventory (BPI) - Mean Pain Severity [ Time Frame: Early Termination/Final Visit through 12 months ]
    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.

  2. Patient Global Impression of Change (PGIC) [ Time Frame: Early Termination/Final Visit through 12 months ]
    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.

  3. Visual Analog Scale Pain Intensity (VASPI) [ Time Frame: Early Termination/Final Visit through 12 months ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

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

  1. Subjects must be at least 18 years of age and no more than 75 years old.
  2. Clinically diagnosed with severe chronic pain for at least a 6-month period.
  3. 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.
  4. Subject agrees to sign a Pain Treatment Agreement (Narcotic Contract) limiting narcotic prescriptions to the study medication prescribed by the investigator.
  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 who can receive an MRI if required by the study protocol.
  8. Provides written Ethics Committee approved informed consent.
  9. 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 breast-feeding.
  2. Subject has any known or suspected allergy to hydromorphone hydrochloride or to the materials of the infusion pump or intrathecal catheter.
  3. 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).
  4. Subjects who show signs of active systemic infection.
  5. Subjects with a metastatic cancer to the spinal canal or a known central nervous system contraindication to intrathecal therapy.
  6. Subjects have a condition requiring diathermy procedures.
  7. Subject has a life expectancy of less than 12 months.
  8. Subjects who are unable or unwilling to return to all of the required follow-up visits.
  9. As a result of medical review and physical examination, the Investigator considers the subject unfit for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01709747

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United States, North Carolina
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Piramal Critical Care, Ltd.
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Principal Investigator: Richard Rauck, MD Carolinas Pain Institute
  Study Documents (Full-Text)

Documents provided by Piramal Critical Care, Ltd.:
Study Protocol  [PDF] August 1, 2016
Statistical Analysis Plan  [PDF] February 4, 2019

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Responsible Party: Piramal Critical Care, Ltd. Identifier: NCT01709747    
Other Study ID Numbers: CNS-HYD202US
First Posted: October 18, 2012    Key Record Dates
Results First Posted: August 25, 2021
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Piramal Critical Care, Ltd.:
Hydromorphone Hydrochloride
Chronic Pain
Implantable Pump
Additional relevant MeSH terms:
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Chronic Pain
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents