Single-arm Study to Assess the Safety of Hydromorphone Hydrochloride by Intrathecal Administration
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 3, Open-Label, Single-Arm Study To Assess The Safety Of Hydromorphone Hydrochloride Delivered By Intrathecal Administration|
- Frequency of Adverse Events during a 12-month period of treatment with intrathecal hydromorphone. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]The primary endpoint of this trial is Safety. There is no formal efficacy assessment planned in this open-label safety study. The patient status will be assessed by providing a VASPI score at each study visit. Subjects who drop out provide a VASPI assessment prior to discontinuation from the study.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
Experimental: Hydromorphone Hydrochloride
Hydromorphone hydrochloride for intrathecal administration, 12 months safety evaluation
Drug: Hydromorphone Hydrochloride
Opioid for chronic pain
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709747
|United States, North Carolina|
|The Center for Clinical Research|
|Winston-Salem, North Carolina, United States, 27103|
|Principal Investigator:||Richard Rauck, MD||Carolinas Pain Institute|