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An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain

NCT01205126 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2014-02-03

Study results available
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Summary

The purpose of this study is to compare the safety and efficacy of Oral Osmotic Therapeutic System (OROS) hydromorphone hydrochloride (HCl) with controlled-release oxycodone HCl in participants with cancer-related pain.

Conditions

Interventions

DRUG

Hydromorphone HCl

Hydromorphone HCl will be administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of Titration phase and 28 days of Maintenance phase. Starting dose will be based on participant's previous daily opioid dose.

DRUG

Oxycodone HCl CR

Oxycodone HCl will be administered in dose of 10, 20, 30 and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioids dose.

DRUG

Placebo

Placebo will be administered to the participants receiving hydromorphone HCl or oxycodone HCl CR along with the study treatment to maintain necessary blinding.

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research and Development Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT01205126 on ClinicalTrials.gov