Study to Evaluate Effectiveness and Tolerability of OROS Hydromorphone for Cancer Pain Treatment in Korean Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01621100|
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : September 6, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cancer Pain||Drug: OROS hydromorphone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Open-Label, Multicenter, Single-Arm, Interventional Study to Evaluate the Efficacy and Tolerability of Once-Daily Oros Hydromorphone for Cancer Pain Treatment in Korean Cancer Patients.|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
Experimental: OROS hydromorphone
Once-Daily OROS (Osmotic release oral system [a controlled release oral drug delivery system in the form of a tablet]) hydromorphone
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.
- 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) [ Time Frame: up to 17 days ]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).
- Korean Brief Pain Inventory (K-BPI) scores [ Time Frame: up to 17 days ]A survey (questionnaire) to measures the pain intensity, the effect of pain on the performance of everyday life, effect of medicines for pain treatment and degree of pain reduction.
- European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) scores [ Time Frame: up to 17 days ]Quality of life measurement survey with 30 questions that ask about the health status of cancer patients.
- Patient's Global Assessment (PGA) scores [ Time Frame: up to 17 days ]Patient checks any of the 5 stages: 1 = Not effective, 2 = Normal, 3 = Effective, 4 = Very Effective, 5 = Excellently effective based on how effective the study medication is in their treatment of pain after the last evaluation.
- Investigator's Global Assessment scores [ Time Frame: up to 17 days ]Study investigator checks any of the 5 stages: 1 = Not effective, 2 = Normal, 3 = Effective, 4 = Very Effective, 5 = Excellently effective based on how effective the study medication is in their treatment of pain after the last evaluation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621100
|Korea, Republic of|
|Cheonan City, Korea, Republic of|
|Cheonan, Korea, Republic of|
|Cheongju, Korea, Republic of|
|Daejeon, Korea, Republic of|
|Hwasun Gun, Korea, Republic of|
|Jeonju-Si, Korea, Republic of|
|Jinju-Si, Korea, Republic of|
|Study Director:||Janssen Korea, Ltd Clinical Trial||Janssen Korea, Ltd|