Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration

NCT01709721 | Completed Phase 3 Results

• 1 other identifier: CNS-HYD201US
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Management of Chronic Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Who Are Treatment Failures During the Double-blind Randomized Withdrawal Period

  Treatment failure during the Randomized Phase is defined as at least one of the following: a) increase of \>= 20mm VASPI vs. baseline over 5 days; b) intolerable pain that in investigator's opinion requires intervention; or c) pain-related interventions that violate protocol from Day 84 to Day 119. Note: Baseline pain for the randomized phase is defined as the average of the last 5 days with daily pain measurements while on an optimal intrathecal dose of Hydromorphone, between Days 77 and 83 of the open label dosing period. Note: A subject who does not have sufficient data for evaluation, drops out for any other reasons that are not listed above or who experiences withdrawal syndrome as identified by COWS \> 12 during the randomized phase will not be classified as a treatment failure. Note: Analysis period is from beginning of randomization phase (Day 84) to end of study.

  5 weeks [Baseline (Day 84) to Day 119 Visit]

Secondary Outcomes (9)

• Brief Pain Inventory (BPI): Pain Severity, "Worst"

  5 Weeks [Baseline (Day 84) to Day 119 Visit]

• Brief Pain Inventory (BPI): Pain Severity "Average"

  5 Weeks [Baseline (Day 84) to Day 119]

• Brief Pain Inventory (BPI): Pain Severity Summary Measure

  5 Weeks [Baseline (Day 84) to Day 119]

• Brief Pain Inventory: Interference With Function Summary Measure

  5 Weeks [Baseline (Day 84) to Day 119]

• Short-Form McGill Pain Questionnaire (SF-MPQ): Summary Score

  5 Weeks [Baseline (Day 84) to Day 119]

Study Arms (2)

Hydromorphone Hydrochloride (Randomized/Double-Blind)

EXPERIMENTAL

Subjects on hydromorphone hydrochloride for the duration of therapy.

Drug: Hydromorphone Hydrochloride; Device: Programmable Implantable pump

Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)

ACTIVE COMPARATOR

Subjects on hydromorphone hydrochloride titrated downward

Drug: Hydromorphone Hydrochloride; Device: Programmable Implantable pump

Interventions

Hydromorphone Hydrochloride DRUG

Opioid for chronic pain

Also known as: Hydromorphone, Opioid

Hydromorphone Hydrochloride (Randomized/Double-Blind); Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)

Programmable Implantable pump DEVICE

Programmable Implantable pump delivering intrathecal hydromorphone

Hydromorphone Hydrochloride (Randomized/Double-Blind); Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)

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:
• Subject must be at least 18 years of age and no more than 75 years old.
• Clinically diagnosed with chronic pain for at least a 6-month period.
• 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.
• Subject agrees to sign a Pain Treatment Agreement (Narcotic Contract) limiting narcotic prescriptions to the study physician.
• 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 with existing SynchroMed II Implantable pumps and are reasonably expected to benefit from intrathecal opioid therapy only.
• Subjects who are capable of receiving an MRI with or without contrast or CT myelogram, 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 are breast-feeding
• Subjects who have participated in an investigational drug or device trial within 4 weeks prior to enrollment.
• Subject has any known or suspected allergy to hydromorphone or to the materials of the infusion pump or intrathecal catheter.
• Subject is scheduled for a pump or catheter replacement within 6 months of their enrollment into the trial.
• 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).
• 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.
• Subject has a condition requiring diathermy procedures.
• Subject has a life expectancy of less than 12 months.
• 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.
• Subject is not considered to be medically or psychologically appropriate for pump implantation.
• 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 ability to perform an MRI or CT myelogram.
• 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

Agnosia

Interventions

Hydromorphone; Analgesics, Opioid; Insulin Infusion Systems

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; 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 L Rauck, MD

  The Center for Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: October 18, 2012
• Study Start: February 1, 2013
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: November 4, 2021
• Results First Posted: August 17, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)