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Single-arm Study to Assess the Safety of Hydromorphone Hydrochloride by Intrathecal Administration

NCT01709747 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2021-08-25

Study results available
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Summary

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

Conditions

Interventions

DRUG

Hydromorphone Hydrochloride

Opioid for chronic pain

DEVICE

Programmable Implantable pump

Device: Programmable Implantable pump Programmable Implantable pump delivering intrathecal hydromorphone

Sponsors & Collaborators

  • Piramal Critical Care, Ltd.

    lead INDUSTRY

Principal Investigators

  • Richard Rauck, MD · Carolinas Pain Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01709747 on ClinicalTrials.gov