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

NCT01709747 | Completed Phase 3 Results

• 1 other identifier: CNS-HYD202US
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pain

Keywords

Hydromorphone Hydrochloride; Hydromorphone; Pain; Chronic Pain; Implantable Pump; Pump; Intrathecal

Outcome Measures

Primary Outcomes (1)

• Granulomas

  Subjects with Clinical Signs and Symptoms of Granuloma \[Note: The primary endpoint of this trial is Safety. There is no formal efficacy assessment planned in this open-label safety study.\]

  12 months

Secondary Outcomes (3)

• Brief Pain Inventory (BPI) - Mean Pain Severity

  Early Termination/Final Visit through 12 months

• Patient Global Impression of Change (PGIC)

  Early Termination/Final Visit through 12 months

• Visual Analog Scale Pain Intensity (VASPI)

  Early Termination/Final Visit through 12 months

Study Arms (1)

Hydromorphone Hydrochloride

EXPERIMENTAL

Hydromorphone hydrochloride for intrathecal administration, 12 months safety evaluation

Drug: Hydromorphone Hydrochloride; Device: Programmable Implantable pump

Interventions

Hydromorphone Hydrochloride DRUG

Opioid for chronic pain

Also known as: Hydromorphone, Opioid

Hydromorphone Hydrochloride

Programmable Implantable pump DEVICE

Device: Programmable Implantable pump Programmable Implantable pump delivering intrathecal hydromorphone

Hydromorphone Hydrochloride

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria to be included:
• Subjects must be at least 18 years of age and no more than 75 years old.
• Clinically diagnosed with severe chronic pain for at least a 6-month period.
• 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.
• Subject agrees to sign a Pain Treatment Agreement (Narcotic Contract) limiting narcotic prescriptions to the study medication prescribed by the investigator.
• Subject must be cognitively intact and, in the opinion of the investigator, capable of participation in the trial.
• Female subjects of child-bearing potential must agree to use a medically acceptable and effective double-barrier method of birth control.
• Subjects who can receive an MRI if required by the study protocol.
• Provides written Ethics Committee approved informed consent.
• Willing to comply with all study procedures and requirements.

You may not qualify if:

• Subjects meeting any of the following criteria will be excluded:
• Women who are pregnant or breast-feeding.
• Subject has any known or suspected allergy to hydromorphone hydrochloride or to the materials of the infusion pump or intrathecal catheter.
• 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).
• Subjects who show signs of active systemic infection.
• Subjects with a metastatic cancer to the spinal canal or a known central nervous system contraindication to intrathecal therapy.
• Subjects have a condition requiring diathermy procedures.
• Subject has a life expectancy of less than 12 months.
• Subjects who are unable or unwilling to return to all of the required follow-up visits.
• As a result of medical review and physical examination, the Investigator considers the subject unfit for the study.

Sponsors & Collaborators

• Piramal Critical Care, Ltd.: lead

Study Sites (1)

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Chronic Pain; Pain

Interventions

Hydromorphone; Analgesics, Opioid; Insulin Infusion Systems

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Drug Delivery Systems; Drug Therapy; Therapeutics; Infusion Pumps; Equipment and Supplies; Artificial Organs; Surgical Equipment

Results Point of Contact

• Title: Heather Kapushoc, Sr. Biostatistician
• Organization: CTI Clinical Trial and Consulting Services

hkapushoc@ctifacts.com

571-315-2574

Study Officials

• Richard Rauck, MD

  Carolinas Pain Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: October 18, 2012
• Study Start: June 1, 2013
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: August 25, 2021
• Results First Posted: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)