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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by CNS Therapeutics
Sponsor:
Information provided by (Responsible Party):
CNS Therapeutics
ClinicalTrials.gov Identifier:
NCT01709747
First received: September 4, 2012
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Chronic Pain
Drug: Hydromorphone Hydrochloride
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by CNS Therapeutics:

Primary Outcome Measures:
  • Frequency of Adverse Events during a 12-month period of treatment with intrathecal hydromorphone. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The primary endpoint of this trial is Safety. There is no formal efficacy assessment planned in this open-label safety study. The patient status will be assessed by providing a VASPI score at each study visit. Subjects who drop out provide a VASPI assessment prior to discontinuation from the study.


Estimated Enrollment: 350
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydromorphone Hydrochloride
Hydromorphone hydrochloride for intrathecal administration, 12 months safety evaluation
Drug: Hydromorphone Hydrochloride
Opioid for chronic pain
Other Names:
  • Hydromorphone
  • Opioid

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709747

Contacts
Contact: Richard E Lowenthal, MSc 858-335-1300 richard@pacificlinkconsulting.com
Contact: Sarina Tanimoto, MD 858-227-3008 sarina@pacificlinkconsulting.com

Locations
United States, Alabama
Alabama Pain Center Enrolling by invitation
Huntsville, Alabama, United States, 35801
United States, Arizona
Center for Pain and Supportive Care Enrolling by invitation
Phoenix, Arizona, United States, 85028
United States, California
Neurovations Enrolling by invitation
Napa, California, United States, 94558
United States, Florida
National Pain Research Institute, LLC Enrolling by invitation
Winter Park, Florida, United States, 32789
United States, Illinois
Millennium Pain Center Enrolling by invitation
Bloomington, Illinois, United States, 61701
United States, Michigan
Pain Care Associates Enrolling by invitation
Bloomfield Hills, Michigan, United States, 48302
William Beaumont Hospital Enrolling by invitation
Royal Oak, Michigan, United States, 48073
United States, North Carolina
The Center for Clinical Research Enrolling by invitation
Winston-Salem, North Carolina, United States, 27103
United States, Oregon
Pain Research of Oregon/Pain Consultants of Oregon Recruiting
Eugene, Oregon, United States, 97401
Contact: Donna M Morgan, MD    541-684-9451    DMorgan@pain-consultants.com   
Contact: Chris Green    541-684-9451    CGreen@pain-consultants.com   
Principal Investigator: Donna M Morgan, MD         
United States, Tennessee
Vanderbilt University Medical Center Enrolling by invitation
Nashville, Tennessee, United States, 37232
United States, Texas
Houston Pain Centers Enrolling by invitation
Houston, Texas, United States, 77030
United States, West Virginia
The Center for Pain Relief Tri-State Enrolling by invitation
Huntington, West Virginia, United States, 25702
Sponsors and Collaborators
CNS Therapeutics
Investigators
Principal Investigator: Richard Rauck, MD Carolinas Pain Institute
  More Information

No publications provided

Responsible Party: CNS Therapeutics
ClinicalTrials.gov Identifier: NCT01709747     History of Changes
Other Study ID Numbers: CNS-HYD202US
Study First Received: September 4, 2012
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by CNS Therapeutics:
Hydromorphone Hydrochloride
Hydromorphone
Pain
Chronic Pain
Implantable Pump
Pump
Intrathecal

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Hydromorphone
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014