Single-arm Study to Assess the Safety of Hydromorphone Hydrochloride by Intrathecal Administration
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|ClinicalTrials.gov Identifier: NCT01709747|
Recruitment Status : Completed
First Posted : October 18, 2012
Results First Posted : August 25, 2021
Last Update Posted : August 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: Hydromorphone Hydrochloride Device: Programmable Implantable pump||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||364 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Open-Label, Single-Arm Study To Assess The Safety Of Hydromorphone Hydrochloride Delivered By Intrathecal Administration|
|Actual Study Start Date :||June 2013|
|Actual Primary Completion Date :||February 2018|
|Actual Study Completion Date :||February 2018|
Experimental: Hydromorphone Hydrochloride
Hydromorphone hydrochloride for intrathecal administration, 12 months safety evaluation
Drug: Hydromorphone Hydrochloride
Opioid for chronic pain
Device: Programmable Implantable pump
Device: Programmable Implantable pump
Programmable Implantable pump delivering intrathecal hydromorphone
- Granulomas [ Time Frame: 12 months ]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.]
- Brief Pain Inventory (BPI) - Mean Pain Severity [ Time Frame: Early Termination/Final Visit through 12 months ]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) [ Time Frame: Early Termination/Final Visit through 12 months ]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) [ Time Frame: Early Termination/Final Visit through 12 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|