Study Evaluating Safety and Tolerability of Oxycodone in Patients With Moderate to Severe Cancer Pain

Study Overview
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Brief Summary
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This study is to evaluate the safety and tolerability of oxycodone control-released (CR) and/or immediate-released (IR) use in patients with moderate to severe cancer pain in a 3-months period in Taiwan.

Detailed Description
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This is an open label, long-term study carrying in multi-centers. Around 200 patients with moderate to severe cancer pain (NRS ≥ 4) who agreed and signed informed consent will be enrolled to receive oxycodone with continuous around-the-clock pattern. The study is to evaluate the safety and tolerability of cancer patients who receive CR and/or IR oxycodone. The number and percentage of patients with adverse events and serious adverse events will be recorded throughout the study. The study will continue for 3 months to observe the safety and tolerability. After screening at Screening visit, patients begin the study by the first day visit (Day 1). Pain assessment, study related questionnaires are giving out to measure the baseline scale of each patient. Questionnaires including rate of quality of analgesia, EQ-5D and clinical opiate withdrawal scale (COWS). The prescription of the study drug will be recorded from Day 1. Patients will need to visit bi-weekly, including Wk 2 (Day 14±3), Wk 4 (Day 28±3), Wk 6 (Day 42±3), Wk 8 (Day 56±3), Wk 10 (Day 70±3) and Wk 12 (Day 84±3). Pain assessment will be assessed in each visit, drug accountability will be recorded accordingly. The rate of quality of Analgesia will be assessed in each visit; QoL (EQ-5D) will be recorded in Wk 4, Wk 8 and Wk 12. The COWS will be assessed again in Wk 12. The safety for individual patient will be followed during study up to 2 weeks after the end of treatment (EOT) or early termination (ET). The telephone contact for safety follow-up is acceptable for this study.

Official Title
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A Long Term, Open-Label, Multi-Center Study Evaluating Safety and Tolerability of Oxycodone in Patients With Moderate to Severe Cancer Pain

Conditions
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Cancer, Pain

Intervention / Treatment
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* Drug: Oxycodone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer patients aged 20 years old and over ECOG ≤ 2 Moderate to severe pain intensity (NRS pain score ≥ 4) Cancer-related pain that requires treatment with continuous around-the-clock strong opioid analgesic Patients who will not be treated with radiotherapy within 7 days prior to screening and during study Patients or his/her caregivers who are able to fill out the questionnaire forms Patient provided signed informed consent Exclusion Criteria: Patients diagnosed with non-cancer pain or unexplained pain Patients who cannot be applicable for oral administration Patients who have constipation (CTCAE grade 3 and above) Patients with evidence of significant structural/functional abnormalities of GI tract or planned to undergo surgeries that have high risk lead to gastrointestinal stenosis, blind loop or gastrointestinal obstruction during study Abnormal lab results, with obvious clinical significance, such as the creatinine ≥ 2 fold of upper limit of normal value, or ALT or AST ≥ 2.5 fold of upper limit of normal value (≥ 5 fold, to the patients with liver metastasis or primary liver cancer), or liver function of Child C grade prior to study Pregnant or nursing (lactating) women Patients who are drug or alcohol abuse Patients with moderate to severe psychiatric problems Patients who have hypersensitivity to oxycodone Patients who are clinically unstable or have a life expectancy of less than three months making completion of the trial unlikely

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxycodone treatment<br>Patients will take either control-released oxycodone (OxyContin® 10mg and 20mg) or immediate-released oxycodone (OxyNorm® 5mg) or both for initial dose and used it to titrate his/her background dose. After regular time assessment of the pain score (NRS), if the pain control is inadequate (NRS ≥ 4), a total daily dose in 24hrs will be summed up for the next dose titration until reach a stable dose (as defined as total daily dose is fixed for at least two weeks). | Drug: Oxycodone<br>* Patients will take either CR oxycodone or IR oxycodone or both for initial dose and used it to titrate his/her background dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and percentage of patients with adverse events (AEs) and serious adverse events (SAEs) | Number and percentage of patients with adverse events (AEs) and serious adverse events (SAEs) | Up to 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline pain intensity scale (NRS) | The change from baseline pain intensity scale (NRS) to each visit | Up to 12 weeks | 
| Time (days) needs in first titration to a stable dose | The time (days) needs in first stable titration | Up to 12 weeks | 
| Average dosage (mg/day) needs in first titration to a stable dose | The average dosage needs in first stable titration | Up to 12 weeks | 
| Quality of analgesia using rating of excellent, very good, good, fair or poor | The percentage of patients rating quality of analgesia of excellent, very good, good, fair or poor | Up to 12 weeks | 
| Treatment discontinuation reason (due to AE, withdraw consent, or any kinds of reasons) | Analysis treatment discontinue reason (due to AE, withdraw consent, or any kinds of reasons) | Up to 12 weeks | 
| Change from baseline in QoL questionnaire (EQ-5D) | The change from baseline in QoL questionnaire (EQ-5D) | Up to 12 weeks | 
| Opiate withdrawal level by Clinical Opiate Withdrawal Scale (COWS) | The change of clinical opiate withdrawal scale (COWS) from baseline | Up to 12 weeks | 
| Safety and tolerability (PE and vital sign change from baseline) | The change from baseline in PE and vital sign | Up to 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxycodone, Cancer Pain, Long-term use