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Study to Evaluate Effectiveness and Tolerability of OROS Hydromorphone for Cancer Pain Treatment in Korean Patients

NCT01621100 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2013-09-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness and tolerability of Once-Daily OROS ("Osmotic Release Oral System" \[a controlled release oral medication delivery system in the form of a tablet\]) hydromorphone for cancer pain treatment in Korean cancer patients.

Conditions

  • Cancer Pain

Interventions

DRUG

OROS hydromorphone

Type= exact number, unit= mg, number= 4, form= tablet, route= oral, administered from 1st evaluation day (Day 1) to 2nd evaluation day (Day 15±2). Dosage adjustment: If NRS (Numeric Rating Scale) =4 or more then dose can be increased by 4mg until the average pain intensity for the past 24 hours is adjusted to lower than NRS 3. For the treatment of breakthrough pain, if necessary the one-time administration dose of quick-effect OROS Hydromorphone shall be 2mg up to the daily dosage of the study medicine, 12mg.

Sponsors & Collaborators

  • Janssen Korea, Ltd., Korea

    lead INDUSTRY

Principal Investigators

  • Janssen Korea, Ltd Clinical Trial · Janssen Korea, Ltd

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • South Korea

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 NCT01621100 on ClinicalTrials.gov