Clinical trial NCT03176121: Study Evaluating Safety and Tolerability of Oxycodone in Patients With Moderate to Severe Cancer Pain
Official title: A Long Term, Open-Label, Multi-Center Study Evaluating Safety and Tolerability of Oxycodone in Patients With Moderate to Severe Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer
Pain
Keywords: Oxycodone
Cancer Pain
Long-term use
Lead sponsor: Taiwan Mundipharma Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-05
Enrollment: 73
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number and percentage of patients with adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to 14 weeks
Secondary outcomes:
measure: Change from baseline pain intensity scale (NRS)
timeFrame: Up to 12 weeks
measure: Time (days) needs in first titration to a stable dose
timeFrame: Up to 12 weeks
measure: Average dosage (mg/day) needs in first titration to a stable dose
timeFrame: Up to 12 weeks
measure: Quality of analgesia using rating of excellent, very good, good, fair or poor
timeFrame: Up to 12 weeks
measure: Treatment discontinuation reason (due to AE, withdraw consent, or any kinds of reasons)
timeFrame: Up to 12 weeks
measure: Change from baseline in QoL questionnaire (EQ-5D)
timeFrame: Up to 12 weeks
measure: Opiate withdrawal level by Clinical Opiate Withdrawal Scale (COWS)
timeFrame: Up to 12 weeks
measure: Safety and tolerability (PE and vital sign change from baseline)
timeFrame: Up to 14 weeks
Other outcomes:
Locations:
city: Chang-hua
country: Taiwan
facility: Changhua Christian Hospital
city: Chiayi City
country: Taiwan
facility: Chang Gung Memorial Hospital, Chiayi branch
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital, Kaohsiung branch
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital, Keelung branch
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: MacKay Memorial Hospital
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital, LinKou branch
Study officials:
References:
citation: Breivik H, Cherny N, Collett B, de Conno F, Filbet M, Foubert AJ, Cohen R, Dow L. Cancer-related pain: a pan-European survey of prevalence, treatment, and patient attitudes. Ann Oncol. 2009 Aug;20(8):1420-33. doi: 10.1093/annonc/mdp001. Epub 2009 Feb 24.
citation: Caraceni A, Hanks G, Kaasa S, Bennett MI, Brunelli C, Cherny N, Dale O, De Conno F, Fallon M, Hanna M, Haugen DF, Juhl G, King S, Klepstad P, Laugsand EA, Maltoni M, Mercadante S, Nabal M, Pigni A, Radbruch L, Reid C, Sjogren P, Stone PC, Tassinari D, Zeppetella G; European Palliative Care Research Collaborative (EPCRC); European Association for Palliative Care (EAPC). Use of opioid analgesics in the treatment of cancer pain: evidence-based recommendations from the EAPC. Lancet Oncol. 2012 Feb;13(2):e58-68. doi: 10.1016/S1470-2045(12)70040-2.
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