NCT01621100

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 6, 2013

Status Verified

September 1, 2013

Enrollment Period

9 months

First QC Date

April 10, 2012

Last Update Submit

September 5, 2013

Conditions

Cancer Pain

Keywords

Cancer painOROSOsmotic release oral systemHydromorphonePainkillerOpioid analgesicKorean patients

Outcome Measures

Primary Outcomes (1)

  • Number of patients with 50% or more average Pain Intensity Difference (PID) from 1st evaluation day (Day 1) to the 2nd evaluation day (Days 15±2)

    Average pain intensity is calculated (on 1st and 2nd evaluation days) for the past 24 hours of the patient using the NRS (Numeric Rating Scale) (0 = No pain, 10 = Unimaginably acute pain). PID (pain intensity difference) %= \[NRS (1st evaluation day) - NRS (2nd evaluation day)\]/ NRS (1st evaluation day).

    up to 17 days

Secondary Outcomes (4)

  • Korean Brief Pain Inventory (K-BPI) scores

    up to 17 days

  • European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) scores

    up to 17 days

  • Patient's Global Assessment (PGA) scores

    up to 17 days

  • Investigator's Global Assessment scores

    up to 17 days

Study Arms (1)

OROS hydromorphone

EXPERIMENTAL

Once-Daily OROS (Osmotic release oral system \[a controlled release oral drug delivery system in the form of a tablet\]) hydromorphone

Drug: OROS hydromorphone

Interventions

OROS hydromorphoneDRUG

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.

OROS hydromorphone

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cancer pain and require opioid analgesics
  • Average pain intensity measured at the baseline (patient's medical status before any treatment or research is done) for the past 24 hours over Numeric Rating Scale (NRS) is 4
  • Never taken continuous-type strong opioid analgesics
  • Must be post-menopausal or if pre-menopausal, must use an acceptable method of birth control

You may not qualify if:

  • Acute digestion related disease, such as dysphagia (difficulty in swallowing), vomiting, no enterokinesia (movements of intestine), intestinal obstruction, acute intestinal stricture (narrowing of a passageway)
  • Expected to undergo radioactive treatment (radiation therapy) between Day 1 and Day 15 of study
  • Being administered with monoamine oxidase inhibitor (eg, moclobemide, selegiline, toloxatone, etc) or within 2 weeks of administration thereof

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Cheonan, South Korea

Location

Unknown Facility

Cheongju-si, South Korea

Location

Unknown Facility

Daejeon, South Korea

Location

Unknown Facility

Hwasun Gun, South Korea

Location

Unknown Facility

Jeonju, South Korea

Location

Unknown Facility

Jinju, South Korea

Location

Related Links

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Janssen Korea, Ltd Clinical Trial

    Janssen Korea, Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2012

First Posted

June 18, 2012

Study Start

December 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 6, 2013

Record last verified: 2013-09

Locations

KR(6)