At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 153 enrolled
Drug / intervention
Hydromorphone Hydrochloride +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Controlled, Two-Arm, Parallel Group, Randomized Withdrawal Study to Assess the Safety and Efficacy of Hydromorphone Hydrochloride Delivered by Intrathecal Administration Using a Programmable Implantable Pump
In Brief
A Phase 3 clinical trial evaluating Hydromorphone Hydrochloride and Programmable Implantable pump for Management of Chronic Pain. Completed, enrolled 153 participants across 1 site.
Detailed Summary
The purpose of this study is to determine the safety and efficacy of hydromorphone hydrochloride by intrathecal administration using a programmable implantable pump.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsManagement of Chronic Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2012
Enrollment StartFeb 2013
Primary CompletionFeb 2018
TodayJul 2026
First PostedOct 18, 2012
Enrollment StartFeb 1, 2013
Primary CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 13.7 years ago
Interventions
Hydromorphone Hydrochloridedrug
Opioid for chronic pain
Programmable Implantable pumpdevice
Programmable Implantable pump delivering intrathecal hydromorphone