- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03024515
Opioids Titration Study in Advanced Cancer Patients in Hong Kong
A Pilot Randomized Open-labeled Study Comparing a Structured Titration Method of immediate-and Sustained- Release Oxycodone Versus Opioids Titration of Investigators' Choice in Advanced Cancer Patients in Hong Kong
Pain is a common symptom that is experienced by patients with advanced cancer. Whilst mild pain can usually be controlled with simple analgesics, more severe pain may require initiation of opioid analgesics. The World Health Organization (WHO) has developed a specific guideline for titration of analgesics. Known as the WHO Pain Ladder, patients who have severe pain despite non-opioid and weak opioid analgesics are advised to step up to level 3 - "Strong Opioids". Morphine is the most common opioid strong analgesic prescribed in Hong Kong. To the best of our knowledge, there is no formal opioid pain control guideline developed for cancer patients in Hong Kong. The prescription practices of various physicians who treat advance cancer patients, including oncologists and palliative care physicians have never been audited or standardized.
Furthermore, there are inherent issues with the administration of oral morphine. Currently, only one fixed concentration is available in a liquid formulation. Patients are known to have difficulties in receiving the appropriate dose. Accurate measurement of the volume required is extremely difficult, and many a times patients will report to have spilled the oral morphine during decanting, or will report that they have not been taking adequate doses because they are worried that they will decant too much into a spoon or syringe and overdose themselves.
Oxycodone is a semisynthetic strong opioid analgesic, which has recently been introduced to Hong Kong. It is formulated as a capsule, and again, 2 preparations (sustained-release (Oxycontin) and immediate release (Oxycodone IR)) are available. Inherent advantages include ease of administration; different groups have previously reported less adverse effects and better treatment compliance. However, to date, there has been no prospective 'head-to-head' comparison have ever been carried out comparing this with the traditional, well-accepted methods.
The purpose of this study is to assess whether or not the use of Oxycontin and Oxycodone IR may be superior to traditional medication choices and schedules in terms of time required for onset of pain control, the side effect profile, patients' tolerability and compliance to treatment. Interestingly, through this randomized open-label prospective study, we also aim to capture information on current opioid prescription practices by clinicians who manage patients with advanced cancers, which will be useful for us to consider the establishment of territory-wide treatment guidelines at a later juncture.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- Department of Clinical Oncology, Prince of Wales Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patient with moderate to severe cancer pain, and:
- Opioid naïve patients, who were administrated NSAIDs or weak opioids and currently with poor pain control, intend to be treated with strong opioids
- For the patients who need long term administration of hormone or targeting therapy or bisphosphonates therapy, the treatments will maintain from 3 days prior to randomization to end of the study as much as possible.
- For patients who need radiotherapy or chemotherapy, these therapies should be conducted during maintaining phase and completed as assuring as possible before last follow-up.
Exclusion Criteria:
- The pure neuropathic pain or unexplained pain, pain that only occurs during moving; Acute pain
- The patients who are not applicable for oral administration
- Any disease that may lead to respiration inhibition of the subjects
- Monoamine oxidase inhibitor (MAOI) was administrated one week before randomization;
- There are abnormal results, with obvious clinical significance, from lab testing, such as the creatinine is ≥2-fold of upper limit of normal value, or ALT or AST is ≥2-fold of upper limit of normal value, or liver function is Child C grade;
- There are potential gastrointestinal diseases or the risk of surgical operation, which may lead to gastrointestinal stenosis, blind loop or gastrointestinal obstruction;
- Patients have been exposed to prolonged-release oxycodone tablets or other strong opioids drugs before study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Standard Practice Arm
Standard Practice Arm with opioids titration of physicians' choice
|
Standard Practice Arm
|
Experimental: Structured Tritration Arm
Structured titration method with predefined titration steps with the use of oxycodone immediate-release and oxycodone sustained-release preparations.
|
comprising of oxycodone immediate release (OXYNORM) and oxycodone sustained release (OXYCONTIN) in pre-defined doses and frequencies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to stabilization of pain control during titration phase
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time of analgesic onset
Time Frame: 1 year
|
1 year
|
Number of breakthrough medications required during the titration phase
Time Frame: 1 year
|
1 year
|
Quality of Life assessments using the EORTC QLQ-C15-PAL instrument
Time Frame: 1 year
|
1 year
|
A descriptive assessment of opioids prescription practice amongst practicing oncologists in Hong Kong
Time Frame: 1 year
|
1 year
|
Safety profile and adverse events
Time Frame: 1 year
|
1 year
|
Descriptive summary of the use of opioids and titration by practicing clinicians
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYM012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain Control
-
Ascension Genesys HospitalRecruiting
-
Overseas Pharmaceuticals, Ltd.Virginia Contract Research Organization Co., Ltd.Terminated
-
New York Presbyterian Brooklyn Methodist HospitalCompleted
-
Universidade Estadual de Ponta GrossaCompleted
-
Severance HospitalCompletedPain ControlKorea, Republic of
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...Recruiting
-
University of Nevada, Las VegasCompleted
-
Vanderbilt UniversityWithdrawn
-
Medical University of South CarolinaCompleted
-
Erzincan UniversityUnknownIntraoperative Pain ControlTurkey
Clinical Trials on opioids titration
-
University Hospital, AntwerpCompletedObstructive Sleep ApneaBelgium
-
Sociedad Española de Neumología y Cirugía TorácicaCompletedObesity Hypoventilation Syndrome | Chronic Hypercapnic Respiratory FailureSpain
-
Rigshospitalet, DenmarkAbbVieCompleted
-
Hospital Italiano de Buenos AiresCompletedAcute Respiratory Distress Syndrome | Capnography
-
Southeast University, ChinaCompletedAcute Exacerbation Chronic Obstructive Pulmonary DiseaseChina
-
Laval UniversityRecruitingCOPD Exacerbation | Hypoxemia | Hyperoxia | Oxygen Toxicity | Hypoxic Respiratory FailureCanada
-
Centre Hospitalier de LensTerminated
-
Sichuan Provincial People's HospitalNot yet recruitingUnrecognized ConditionChina
-
Hvidovre University HospitalBispebjerg HospitalCompletedCOPD | HypoxemiaDenmark
-
University of SaskatchewanCompleted