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

Taiwan Mundipharma Pharmaceuticals Ltd.73 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer Pain

Interventions

OxycodoneDRUG

Patients will take either CR oxycodone or IR oxycodone or both for initial dose and used it to titrate his/her background dose.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Cancer patients aged 20 years old and over 2. ECOG ≤ 2 3. Moderate to severe pain intensity (NRS pain score ≥ 4) 4. Cancer-related pain that requires treatment with continuous around-the-clock strong opioid analgesic 5. Patients who will not be treated with radiotherapy within 7 days prior to screening and during study 6. Patients or his/her caregivers who are able to fill out the questionnaire forms 7. Patient provided signed informed consent Exclusion Criteria: 1. Patients diagnosed with non-cancer pain or unexplained pain 2. Patients who cannot be applicable for oral administration 3. Patients who have constipation (CTCAE grade 3 and above) 4. 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 5. 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 6. Pregnant or nursing (lactating) women 7. Patients who are drug or alcohol abuse 8. Patients with moderate to severe psychiatric problems 9. Patients who have hypersensitivity to oxycodone 10. Patients who are clinically unstable or have a life expectancy of less than three months making completion of the trial unlikely

Locations (10)

Changhua Christian Hospital

Chang-hua, Taiwan

Chang Gung Memorial Hospital, Chiayi branch

Chiayi City, Taiwan

Chang Gung Memorial Hospital, Kaohsiung branch

Kaohsiung City, Taiwan

Chang Gung Memorial Hospital, Keelung branch

Outcomes

Primary Outcomes

Number and percentage of patients with adverse events (AEs) and serious adverse events (SAEs)

Time frame: Up to 14 weeks

Secondary Outcomes

Change from baseline pain intensity scale (NRS)

The change from baseline pain intensity scale (NRS) to each visit

Time frame: Up to 12 weeks

Time (days) needs in first titration to a stable dose

The time (days) needs in first stable titration

Time frame: Up to 12 weeks

Average dosage (mg/day) needs in first titration to a stable dose

The average dosage needs in first stable titration

Time frame: 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

Time frame: 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)

Time frame: Up to 12 weeks

Change from baseline in QoL questionnaire (EQ-5D)

The change from baseline in QoL questionnaire (EQ-5D)

Time frame: Up to 12 weeks

Opiate withdrawal level by Clinical Opiate Withdrawal Scale (COWS)

Data from ClinicalTrials.gov

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