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Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration

NCT01709721 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2021-11-04

Study results available
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Summary

The purpose of this study is to determine the safety and efficacy of hydromorphone hydrochloride by intrathecal administration using a programmable implantable pump.

Conditions

  • Management of Chronic Pain

Interventions

DRUG

Hydromorphone Hydrochloride

Opioid for chronic pain

DEVICE

Programmable Implantable pump

Programmable Implantable pump delivering intrathecal hydromorphone

Sponsors & Collaborators

  • Piramal Critical Care, Ltd.

    lead INDUSTRY

Principal Investigators

  • Richard L Rauck, MD · The Center for Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01709721 on ClinicalTrials.gov