CancerPhase 4NCT01006356
An Efficacy and Safety Study of Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) in the Reduction of Breakthrough Pain Medication Frequency in Participants With Cancer
A Phase 4 study testing Hydromorphone HCl OROS in people with Cancer and Pain, run by Janssen Korea, Ltd., Korea.
Trial summary
The purpose of this study is to evaluate the clinical efficacy of hydromorphone hydrochloride (HCl) Oral Osmotic System (OROS) by assessing the extent of reduction of medication frequency for the management of breakthrough pain after the administration of hydromorphone HCl OROS in Korean cancer participants. Read more about this study
- Who is it for?
- Ages 20 years and older
- What is being tested?
- Hydromorphone HCl OROS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Aug 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer participants administering only strong oral opioid analgesic for cancer pain control
- Participants administering short-acting narcotic analgesics at least twice daily due to breakthrough pain for 3 days just before Visit 2 (Day 1)
- Participants sufficiently capable of complying overall study requirements including participant diary for pain at the discretion of the Investigators
- Abstinent or surgically sterile female participants
Who cannot join
- Participants with cancer pain who are potentially unresponsive to narcotic analgesics
- Participants with presence or history of drug or alcohol abuse within the past 6 months
- Participants with hypersensitivity to hydromorphone HCl
- Participants with history of colectomy (surgery to remove part or all of the colon)
- Participants with severe digestive tract disease which might interfere with oral analgesic effects, such as dysphagia (trouble swallowing), vomiting, no bowel movement, ileus, and severe enterostenosis that can influence absorption and passing through of oral medication
About this study
Official title: Cancer Pain Management With Hydromorphone HCl ORal Osmotic System in Korean Cancer Patient: Evaluation of Its Clinical Usefulness in Reduction of Breakthrough Pain Medication Frequency
The purpose of this study is to evaluate the clinical efficacy of hydromorphone hydrochloride (HCl) Oral Osmotic System (OROS) by assessing the extent of reduction of medication frequency for the management of breakthrough pain after the administration of hydromorphone HCl OROS in Korean cancer participants.
Read the detailed description
This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than 1 center), prospective (study following participants forward in time) study. The total duration of study will be 3 weeks. The study consists of 2 periods and 4 visits: screening period (1 week; Visit 1) and treatment period (2 weeks; Visit 2, 3 and 4). During screening period at Visit 1, potential participants will receive previously administered oral opioid analgesic until the second visit and with immediate-release opioid analgesic whenever breakthrough pain is present. During treatment period, from second visit to the fourth visit, participants will receive the hydromorphone HCl OROS once daily for 2 weeks. At Investigator's discretion, participants completing 2 weeks of treatment with study drug could be enrolled into the extension phase of 12-weeks. The dose of study drug is flexible and will be increased or decreased based on the frequency of immediate-release opioid analgesic doses needed to manage pain. At second visit, initial dose of hydromorphone will be determined according to the equivalent analgesic effect conversion tablet (oxycodone 10 milligram [mg] twice daily is equal to hydromorphone HCl 8 mg once daily). The Investigator will increase a participant's daily dose if more than 3 breakthrough pain episodes require rescue medication within a 24 hours period. Participants' safety will be monitored throughout the study.
- Being tested
- Hydromorphone HCl OROS
- Keywords
- Hydromorphone hydrochloride Oral Osmotic System, Jurnista
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydromorphone HCl OROSDrug
Hydromorphone HCl OROS 8 mg once daily for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Hydromorphone hydrochloride (HCl) oral osmotic system (OROS) | Experimental | Hydromorphone HCl OROS 8 milligram (mg) once daily for 2 weeks. Receives: Drug: Hydromorphone HCl OROS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain
Percentage of participants with decrease in dosing frequency by 33 percent or more in breakthrough pain (acute pain that comes on rapidly despite the use of pain medication) was determined at final visit (Day 15) compared to Baseline (Day 1 - when the administration of study drug was started).
Measured: Day 15
Secondary outcomes (8)
Frequency of Experiencing Breakthrough Pain
Frequency of experiencing 3 types of breakthrough pain: Idiopathic pain (pain of unknown cause), incidental pain (pain that arises as a result of activity, such as movement of an arthritic joint, stretching a wound) and end-of-dose failure pain was reported.
Measured: Day 1 and Day 15
Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15
K-BPI is an inventory designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of total 9 items in total, and the ninth item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0 to 10, where 0=no pain, 1 to 4=mild pain, 5 to 6=moderate pain and 7 to 10=severe pain.
Measured: Baseline and Day 15
Pain Intensity Score
Average Pain intensity score experienced by Participant over the last 24 hours of Day 3 and Day 13 was recorded. Pain intensity was measured using numerical rating scale (NRS) ranging from 0=no pain to 10=most severe pain.
Measured: Day 3 and Day 13
Global Assessment of Overall Efficacy of Study Drug by Investigator
Investigator evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', 'effective response', 'very effectiveresponse', and 'highly effective response'.
Measured: Day 15
Global Assessment of Overall Efficacy of Study Drug by Participant
Participants evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', 'effective response', 'very effectiveresponse', and 'highly effective response'.
Measured: Day 15
Participant's Preferences Along With Reasons
The number of participants who preferred oral long-acting narcotic analgesics or previously administered oral opioid analgesic were reported along with detailed and specific reasons such as consistent analgesic effect during administration, sleep undisturbed by pain, reduced intake of medication frequency, reduce intake of immediate-release opioid analgesic for breakthrough pain treatment, other and no response, for their preferences. Same participant may have multiple reason for their preference.
Measured: Day 15
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
Investigators evaluated the overall improvement of the participant's condition using CGI scale. The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=greatly improved; 2=somewhat improved; 3=slightly improved; 4=no change; 5=slightly aggravated ; 6=somewhat aggravated; 7=greatly aggarvated.
Measured: Day 15
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) which are based on 4-point scale (1=Not at all to 4=Very much); and global health status and quality of life scale based on 7-point scale (1=very poor to 7=Excellent). All scales and items are averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptomatology or problems.
Measured: Day 1 and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startOct 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd., Korea Clinical Trial, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006356
- Sponsor's protocol ID
- CR015694
- Other IDs
- 42801PAI4006
- Status last verified
- Jul 2013
- First submitted
- 29 Oct 2009
- Last updated
- 8 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Pain Management With Hydromorphone HCl ORal Osmotic System in Korean Cancer Patient: Evaluation of Its Clinical Usefulness in Reduction of Breakthrough Pain Medication Frequency
- ClinicalTrials.gov ID
- NCT01006356
- Acronym / sponsor ID
- CR015694
- Keywords
- Hydromorphone hydrochloride Oral Osmotic System, Jurnista
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 2 Nov 2009 (estimated)
- Results
- Posted 8 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the clinical efficacy of hydromorphone hydrochloride (HCl) Oral Osmotic System (OROS) by assessing the extent of reduction of medication frequency for the management of breakthrough pain after the administration of hydromorphone HCl OROS in Korean cancer participants.
Detailed description
This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than 1 center), prospective (study following participants forward in time) study. The total duration of study will be 3 weeks. The study consists of 2 periods and 4 visits: screening period (1 week; Visit 1) and treatment period (2 weeks; Visit 2, 3 and 4). During screening period at Visit 1, potential participants will receive previously administered oral opioid analgesic until the second visit and with immediate-release opioid analgesic whenever breakthrough pain is present. During treatment period, from second visit to the fourth visit, participants will receive the hydromorphone HCl OROS once daily for 2 weeks. At Investigator's discretion, participants completing 2 weeks of treatment with study drug could be enrolled into the extension phase of 12-weeks. The dose of study drug is flexible and will be increased or decreased based on the frequency of immediate-release opioid analgesic doses needed to manage pain. At second visit, initial dose of hydromorphone will be determined according to the equivalent analgesic effect conversion tablet (oxycodone 10 milligram [mg] twice daily is equal to hydromorphone HCl 8 mg once daily). The Investigator will increase a participant's daily dose if more than 3 breakthrough pain episodes require rescue medication within a 24 hours period. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydromorphone hydrochloride (HCl) oral osmotic system (OROS) | Experimental | Drug: Hydromorphone HCl OROSHydromorphone HCl OROS 8 milligram (mg) once daily for 2 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cancer participants administering only strong oral opioid analgesic for cancer pain control
- Participants administering short-acting narcotic analgesics at least twice daily due to breakthrough pain for 3 days just before Visit 2 (Day 1)
- Participants sufficiently capable of complying overall study requirements including participant diary for pain at the discretion of the Investigators
- Abstinent or surgically sterile female participants
Key exclusion criteria (5 listed)
- Participants with cancer pain who are potentially unresponsive to narcotic analgesics
- Participants with presence or history of drug or alcohol abuse within the past 6 months
- Participants with hypersensitivity to hydromorphone HCl
- Participants with history of colectomy (surgery to remove part or all of the colon)
- Participants with severe digestive tract disease which might interfere with oral analgesic effects, such as dysphagia (trouble swallowing), vomiting, no bowel movement, ileus, and severe enterostenosis that can influence absorption and passing through of oral medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydromorphone HCl OROSHydromorphone HCl OROS 8 mg once daily for 2 weeks. | Drug | Hydromorphone hydrochloride (HCl) oral osmotic system (OROS) |
Primary outcome
Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain
Time frame: Day 15
Percentage of participants with decrease in dosing frequency by 33 percent or more in breakthrough pain (acute pain that comes on rapidly despite the use of pain medication) was determined at final visit (Day 15) compared to Baseline (Day 1 - when the administration of study drug was started).
8 secondary outcomes
Frequency of Experiencing Breakthrough Pain
Time frame: Day 1 and Day 15
Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15
Time frame: Baseline and Day 15
Pain Intensity Score
Time frame: Day 3 and Day 13
Global Assessment of Overall Efficacy of Study Drug by Investigator
Time frame: Day 15
Global Assessment of Overall Efficacy of Study Drug by Participant
Time frame: Day 15
Participant's Preferences Along With Reasons
Time frame: Day 15
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
Time frame: Day 15
European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
Time frame: Day 1 and Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Korea, Ltd., Korea Clinical Trial study director
Janssen Korea, Ltd., Korea
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydromorphone HCl OROS in people with Cancer and Pain, run by Janssen Korea, Ltd., Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain (time frame: Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2013.