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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01709747
• Other study ID #: CNS-HYD202US
• Status: Completed
• Phase: Phase 3
• Start date: June 2013
• Est. completion date: February 2018

Study information

• Verified date: August 2021
• Source: Piramal Critical Care, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 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).

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Hydromorphone Hydrochloride
Opioid for chronic pain

Device:
• Programmable Implantable pump
Device: Programmable Implantable pump Programmable Implantable pump delivering intrathecal hydromorphone

Locations

Country	Name	City	State
United States	The Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Piramal Critical Care, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Early Termination/Final Visit through 12 months
Secondary	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.	Early Termination/Final Visit through 12 months
Secondary	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.	Early Termination/Final Visit through 12 months