Study to Evaluate Effectiveness and Tolerability of OROS Hydromorphone for Cancer Pain Treatment in Korean Patients
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2011|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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.
Other Name: OROS hydromorphone
This is a prospective (expected to happen), open-label (type of clinical study in which both the researchers and participants know which treatment is being administered), multicenter (conducted at multiple centers), single-arm (only one group), study to evaluate the effectiveness and tolerability (capable to tolerate) of Once-Daily OROS hydromorphone for cancer pain treatment. This is a 14-week study consisting of 2-week efficacy evaluation period (1st evaluation on Day 1 and 2nd evaluation on Days 15±2) and a 12-week extension phase. 99 patients will receive Once-Daily OROS hydromorphone for 2 weeks .After 2 weeks, if a patient has continuous cancer pain and the investigator deems it necessary to administer the same medicine as the study medication then the patient may participate voluntarily in the 12 weeks extension phase. At the extension phase, other continuous-type strong opioid analgesics (painkiller) may be administered at the same time for the adjustment of cancer pain based on the discretion of the investigator.
|Korea, Republic of|
|Cheonan, Korea, Republic of|
|Cheonan City, 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|