CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 364 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.

Search/NCT01709747
NCT01709747Phase 3Completed
CompareCT.gov

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

Piramal Critical Care, Ltd.·interventional·Posted Oct 18, 2012·Updated Aug 25, 2021

In Brief

A Phase 3 clinical trial evaluating Hydromorphone Hydrochloride and Programmable Implantable pump for Chronic Pain. Completed, enrolled 364 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 18, 2012
Enrollment StartJun 1, 2013
Primary CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.7 years ago

Interventions

Hydromorphone Hydrochloridedrug

Opioid for chronic pain

Programmable Implantable pumpdevice

Device: Programmable Implantable pump Programmable Implantable pump delivering intrathecal hydromorphone