Safety and Efficacy Study of Hydromorphone HCl by Intrathecal Administration Using a Programmable Implantable Pump

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by CNS Therapeutics
Sponsor:
Collaborator:
Pacific-Link Consulting LLC
Information provided by (Responsible Party):
CNS Therapeutics
ClinicalTrials.gov Identifier:
NCT01709721
First received: August 24, 2012
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to determine the safety and efficacy of hydromorphone hydrochloride by intrathecal administration using a programmable implantable pump.


Condition Intervention Phase
Management of Chronic Pain
Drug: Hydromorphone Hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by CNS Therapeutics:

Primary Outcome Measures:
  • Superiority of intrathecal hydromorphone hydrochloride as compared to a control arm. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 VASPI, based on a 3-day average, or who experiences intolerable pain that requires intervention, will be considered a treatment failure


Secondary Outcome Measures:
  • Functionality based on a Brief Pain Inventory [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    Patients ability to function and perform tasks without significant pain based on the BPI scale.


Estimated Enrollment: 250
Study Start Date: February 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Subjects on hydromorphone hydrochloride for the duration of therapy.
Drug: Hydromorphone Hydrochloride
Subjects who meet criteria for randomization, will be randomized in a 1:1 ratio to either the active arm or control arm.
Other Names:
  • Hydromorphone
  • Opioid
Active Comparator: Titrated off therapy
Subjects on control
Drug: Hydromorphone Hydrochloride
Active Control Based on Dose Reduction

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

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

Inclusion Criteria:

  1. Subject must be at least 18 years of age and no more than 75 years old. of the following criteria to be included:
  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.
  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. Patients with existing SynchroMed II Implantable pumps and are reasonably expected to benefit from intrathecal opioid therapy.
  8. Subjects who are capable of receiving an MRI 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:

  1. Women who are pregnant or are breast-feeding of the following criteria will be excluded:
  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. 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. Subject has a condition requiring diathermy procedures.
  7. Subject has a life expectancy of less than 12 months.
  8. Subject cannot independently comprehend and participate in the required assessments, including responding to the VASPI, SF-MPQ, COWS, BPI and PGIC measurement tools.
  9. Subject is not considered to be medically or psychologically appropriate for pump implantation.
  10. 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 function of the implantable intrathecal pump.

  11. As a result of medical review and physical examination, the Investigator considers the subject unfit for the study.
  12. 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 patient would benefit from intrathecal administration of the drug product.
  13. Subjects who have previously been unresponsive to intrathecal hydromorphone therapy.
  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: NCT01709721

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 Recruiting
Huntsville, Alabama, United States, 35801
Contact: Leah Pinkerton, BSN, RN    256-882-2003 ext 1300    lpinkerton@alabamapaincenter.com   
Principal Investigator: K. Dean Willis, MD         
United States, Arizona
Center for Pain and Supportive Care Recruiting
Phoenix, Arizona, United States, 85028
Contact: Lisa Stearns, MD    480-889-0180    ljstearns@yahoo.com   
Contact: Krisstin Hammond    480.516.0233      
Principal Investigator: Lisa Stearns, MD         
United States, California
Neurovations Recruiting
Napa, California, United States, 94558
Contact: Eric Grigsby, MD, MBA    707-252-9606    eg@neurovations.com   
Contact: Whitney Michiels    707-252-9606    whitney@neurovations.com   
Principal Investigator: Eric Grigsby, MD, MBA         
United States, Florida
National Pain Research Institute, LLC Recruiting
Winter Park, Florida, United States, 32789
Contact: Cherian K Sajan, MD    407-622-5766    csajan@natpain.com   
Contact: Joan Cutillo    407-622-5766    jcutillo@natpain.com   
Principal Investigator: Cherian K Sajan, MD         
United States, Illinois
Advocate Healthcare Not yet recruiting
Normal, Illinois, United States, 61761
Contact: Ramsin Benyamin, MD         
Principal Investigator: Ramsin Benyamin, MD         
United States, Michigan
Pain Care Associates Recruiting
Bloomfield Hills, Michigan, United States, 48302
Contact: Todd Lininger, MD    248-751-7246    telininger@gmail.com   
Contact: Kelli Bocan    248-751-7246 ext 421    kbocan@npcmi.com   
Principal Investigator: Todd Lininger, MD         
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Michael Sikorsky, DO       sikorskymsu@yahoo.com   
Contact: Cynthia Turzewski, RN    248.898.1907    Cynthia.Turzewski@beaumont.edu   
Principal Investigator: Michael Sikorsky, DO         
United States, North Carolina
The Center for Clinical Research Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Richard Rauck, MD, FACP         
Principal Investigator: Richard L Rauck, MD         
United States, Ohio
Nagy Mekhail Recruiting
Cleveland, Ohio, United States, 44195
Contact: Hani Yousef    216-636-1484    yousefh@ccf.org   
Principal Investigator: Nagy Mekhail, MD         
United States, Pennsylvania
Moss Rehab Recruiting
Elkins Park, Pennsylvania, United States, 19027
Contact: Michael Saulino, MD, PhD    215-663-6607    docsaulino@msn.com   
Contact: Marianne Pedicone, RN, BA, CRRN    215-663-6112    pedicone007@comcast.net   
Principal Investigator: Michael Saulino, MD, PhD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Marc Huntoon, MD    615-322-6033    marc.huntoon@vanderbilt.edu   
Contact: Donna Nelson, RN    615-343-9769    donna.nelson@vanderbilt.edu   
Principal Investigator: Marc Huntoon, MD         
United States, Texas
Houston Pain Centers Recruiting
Houston, Texas, United States, 77030
Contact: Allen Burton, MD    713-737-7246    awburtonmd@gmail.com   
Contact: Erica N Butler    713-973-7246    ebutler@houstonpainassociates.com   
Principal Investigator: Allen Burton, MD         
United States, West Virginia
The Center for Pain Relief Tri-State Recruiting
Huntington, West Virginia, United States, 25702
Contact: David Caraway, MD, PhD    304-526-8384    carawaymd@aol.com   
Contact: Kathy Clagg, RN    304 526-8384    kclagg@st-marys.org   
Principal Investigator: David Caraway, MD, PhD         
Sponsors and Collaborators
CNS Therapeutics
Pacific-Link Consulting LLC
Investigators
Principal Investigator: Richard L Rauck, MD The Center for Clinical Research
  More Information

No publications provided

Responsible Party: CNS Therapeutics
ClinicalTrials.gov Identifier: NCT01709721     History of Changes
Other Study ID Numbers: CNS-HYD201US
Study First Received: August 24, 2012
Last Updated: August 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by CNS Therapeutics:
Hydromorphone
Hydromorphone Hydrochloride
Pain Management
Non-narcotic analgesics

Additional relevant MeSH terms:
Hydromorphone
Analgesics, Non-Narcotic
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 20, 2014