Back to results

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

Primary Purpose

Chronic Pain

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Hydromorphone Hydrochloride

Programmable Implantable pump

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Hydromorphone Hydrochloride, Hydromorphone, Pain, Chronic Pain, Implantable Pump, Pump, Intrathecal

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

The Center for Clinical Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hydromorphone Hydrochloride

Arm Description

Hydromorphone hydrochloride for intrathecal administration, 12 months safety evaluation

Outcomes

Primary Outcome Measures

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.]

Secondary Outcome Measures

Brief Pain Inventory (BPI) - Mean Pain Severity

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.

Patient Global Impression of Change (PGIC)

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.

Visual Analog Scale Pain Intensity (VASPI)

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.

Full Information

NCT ID

NCT01709747

First Posted

September 4, 2012

Last Updated

August 23, 2021

Sponsor

Piramal Critical Care, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01709747

Brief Title

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

Official Title

A Phase 3, Open-Label, Single-Arm Study To Assess The Safety Of Hydromorphone Hydrochloride Delivered By Intrathecal Administration

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

June 2013 (Actual)

Primary Completion Date

February 2018 (Actual)

Study Completion Date

February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Piramal Critical Care, Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

Keywords

Hydromorphone Hydrochloride, Hydromorphone, Pain, Chronic Pain, Implantable Pump, Pump, Intrathecal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

364 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hydromorphone Hydrochloride

Arm Type

Experimental

Arm Description

Hydromorphone hydrochloride for intrathecal administration, 12 months safety evaluation

Intervention Type

Drug

Intervention Name(s)

Hydromorphone Hydrochloride

Other Intervention Name(s)

Hydromorphone, Opioid

Intervention Description

Opioid for chronic pain

Intervention Type

Device

Intervention Name(s)

Programmable Implantable pump

Intervention Description

Device: Programmable Implantable pump Programmable Implantable pump delivering intrathecal hydromorphone

Primary Outcome Measure Information:

Title

Granulomas

Description

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.]

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Brief Pain Inventory (BPI) - Mean Pain Severity

Description

Time Frame

Early Termination/Final Visit through 12 months

Title

Patient Global Impression of Change (PGIC)

Description

Time Frame

Early Termination/Final Visit through 12 months

Title

Visual Analog Scale Pain Intensity (VASPI)

Description

Time Frame

Early Termination/Final Visit through 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Rauck, MD

Organizational Affiliation

Carolinas Pain Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Center for Clinical Research

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs