NCT01709747

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 364 (actual)
• Sponsor: Piramal Critical Care, Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DRUG	Hydromorphone Hydrochloride	Opioid for chronic pain
DEVICE	Programmable Implantable pump	Device: Programmable Implantable pump Programmable Implantable pump delivering intrathecal hydromorphone

Timeline

• Start date: 2013-06-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2012-10-18
• Last updated: 2021-08-25
• Results posted: 2021-08-25

Locations

1 site across 1 country: United States