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A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain.

NCT00261495 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2014-06-03

Study results available
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Summary

The purpose of this study is to compare the effectiveness and safety of sustained- release hydromorphone, formulated to release slowly over time, taken once daily, and controlled- release oxycodone taken twice daily, in patients with chronic non-cancer pain. The study will also determine the dose of sustained-release hydromorphone that provides a level of pain control that is equal to the pain control provided by control-released oxycodone (equi-analgesic dosage).

Conditions

Interventions

DRUG

OROS hydromorphone HCl

8 to 32 mg once daily for 52 weeks (flexible dosing)

DRUG

Oxycodone

10, 20, or 40 mg twice a day for 52 weeks (flexible dosing)

Sponsors & Collaborators

  • Janssen Pharmaceutica N.V., Belgium

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutica N.V. Clinical Trial · Janssen Pharmaceutica N.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Czechia
  • Denmark
  • France
  • Germany
  • Norway
  • Poland
  • Slovakia
  • Slovenia
  • Sweden
  • Switzerland

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 NCT00261495 on ClinicalTrials.gov