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PainNCT01532895

Clinical Usefulness and Quality of Life of OROS Hydromorphone in Patients Who Have Not Been Treated With a Strong Opioid

An observational study of Pain, run by Janssen Korea, Ltd., Korea at 11 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose of this study is to evaluate the usefulness of hydromorphone to treat cancer pain in patients who have not been treated with a strong opioid. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Pain
What is being tested?
Hydromorphone HCI OROS
Type of treatment
Pill or oral medicine
How many people
400 participants
Where
11 sitesSouth Korea
Study dates
Sep 2011to Oct 2012
Phase
Observational
Are there results?
None posted in the registry

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

Study population: Korean cancer patients having cancer pain who visit or are hospitalized at the research centers during the study.

Inclusion Criteria: - Patients who complain of cancer pain and who require administration of hydromorphone HCl - Patients who can follow the requirements of the overall study, including completion of filling out the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, at the investigator's discretion - Signed informed consent Exclusion Criteria: - Patients who received strong continuous narcotic analgesics (eg morphine, fentanyl, oxycodone, hydromorphone) within 4 weeks prior to administration of the study drug - Patients who have a medical history of receiving drugs in the past or currently, or of drug abuse - Patients who did not agree to conduct the approved methods for contraception during the study - Patients who have sustained injuries in physical functions or diseases which may cause abnormalities in absorbing the study drug, excessive accumulation and metabolic or elimination disorder - Patients who are receiving Monoamine Oxidase Inhibitors (MAO) inhibitors or who are within 2 weeks from discontinuation - Patients who need to be excluded based on precautions in the user manual of the study drug, notice and contradictions, at the investigator's discretion

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

South Korea11 sites

  • Study site

    Ansan

  • Study site

    Busan

  • Study site

    Cheongju-si

  • Study site

    Daegu

  • Study site

    Hwasun Gun

  • Study site

    Incheon

  • Study site

    Pusan

  • Study site

    Seognam-Si, Kyungki-Do

  • Study site

    Seoul

  • Study site

    Suwon

  • Study site

    Wonju-Shi

Other trials in South Korea

About this study

Official title: Clinical Usefulness and Quality of Life of OROS Hydromorphone in Strong Opioid-Naïve Cancer Pain Patients; Multicenter, Prospective, Open-Label and Observational Study

The primary purpose of this study is to evaluate the usefulness of hydromorphone to treat cancer pain in patients who have not been treated with a strong opioid.

Read the detailed description

This is a multicenter, prospective, open-label (all people know the identity of the intervention) and observational study. Patients selected for the proposed study are patients complaining of cancer pain who visit or are hospitalized at the research centers during the study, who are not being treated with strong continuous opioid (narcotic medication used against the pain), and who require cancer pain control with hydromorphone, at the investigator's discretion. The study will evaluate the changes in pain relief, level of sleep deprivation, and the patients' quality of life before and after administration of hydromorphone.

Conditions
Pain
Being tested
Hydromorphone HCI OROS
Keywords
Pain, Cancer pain, Hydromorphone, Hydromorphone OROS, Narcotic analgesics, Opioid-naive
Medical subject headings
Pain, Cancer Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hydromorphone HCI OROSDrug

    type= exact number, unit= mg, number=4, form= tablet, route= oral use. One tablet administered once a day. The dose may be increased if the level of pain increases or if the pain-killing effect is insufficient.

Study groups in NCT01532895
Study groupRoleWhat they receive
Hydromorphone HCI OROSNot described
Receives: Drug: Hydromorphone HCI OROS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The ratio of patients with % PID (Pain Intensity Difference) over 30% of patients from the first evaluation date until the third evaluation date, following the administration of hydromorphone HCI to cancer pain patients

    Measured: Baseline and at approximately Day 57

Secondary outcomes (9)

  1. Changes in the Karnofsky Performance Rating Scale (KPRS)

    The KPRS measures the physical functions of cancer patients, and indicates the feasibility of daily life by 10% units from 0% (death) to 100% (normal status in which patients can do activities to the level before disease without limitations).

    Measured: Baseline, and at approximately Days 29 and 57

  2. Change in pain relief (%)

    How much pain was relieved by the pain therapy or medication for the last 24 hours, using %: 0%= nothing reduced and 100%= completely reduced.

    Measured: Baseline, and at approximately Days 29 and 57

  3. Frequency of awakening

    Check whether patients experienced awakening during sleep caused by pain for the last 1 week or not, and measure the frequency (1 = once, 2 = twice, 3 = 3 times, 4 = more than 4 times, 5 = not woken, 6 = never slept).

    Measured: Baseline, and at approximately Days 29 and 57

  4. Level of sleep inconvenience

    Measure the level of sleep inconvenience that patients experienced due to pain for the last 1 week using the Numeric Rating Scale (NRS); 0 = not causing inconvenience, 10 = completely causing inconvenience.

    Measured: Baseline, and at approximately Days 29 and 57

  5. Satisfaction with sleep

    Indicate the overall satisfaction with sleep by improving sleep disturbance caused by pain for the last 1 week using the Numeric Rating Scale (0 "never satisfied" on the left end; 10 "very satisfied" on the right end).

    Measured: Baseline, and at approximately Days 29 and 57

  6. Quality of life assessment measured by the EORTC QLQ-C15 PAL

    The EORTC (European Organization for Research and Treatment of Cancer) QLQ-C15 (Quality of Life Questionnaire Core 15) is a commonly used questionnaire to assess the quality of life of cancer patients taking paliative medicine. This questionnaire consists of questions measuring physical, role, emotional, cognitive and social functions, and answers are given based on a 4-point scale, from 1 (not at all) to 4 (very much so).

    Measured: Baseline, and at approximately Days 29 and 57

  7. Investigator's Global Assessment

    The investigator's global assessment is used to assess how effective the study drug was for the patients after administration of the study drug since the last evaluation date. It is measured by the investigator from the investigator's point of view as 1 = not effective, 2 = normal l, 3 = effective, 4 very effective, and 5 = extremely effective.

    Measured: At approximately Days 29 and 57

  8. Patient's Global Assessment

    The patient's global assessment is used to assess how effective the study drug was for the patients after administration of the study drug since the last evaluation date. It is measured by the patient from the patient's point of view as 1 = not effective, 2 = normal, 3 = effective, 4 = very effective, and 5 = extremely effective.

    Measured: At approximately Days 29 and 57

  9. CGI-I (Clinical Global Impression - Improvement)

    Evaluate how much patients have improved compared with the conditions of patients at baseline, from 1 (very much improved) to 7 (greatly deteriorated).

    Measured: At approximately Days 29 and 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2012 (estimated)
  2. Study startSep 2011
  3. Primary completionSep 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01532895
Sponsor's protocol ID
CR100741
Other IDs
42801PAI4013, HYD-KOR-5011
Status last verified
Mar 2014
First submitted
10 Feb 2012
Last updated
18 Mar 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pain, run by Janssen Korea, Ltd., Korea at 11 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The ratio of patients with % PID (Pain Intensity Difference) over 30% of patients from the first evaluation date until the third evaluation date, following the administration of hydromorphone HCI to cancer pain patients (time frame: Baseline and at approximately Day 57). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01532895.

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 18 Mar 2014.

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