A Phase 4 interventional study of Oxycodone and Oxycodone in Cancer and Pain, sponsored by Taiwan Mundipharma Pharmaceuticals Ltd.. Completed at 4 sites in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-03-18.
Sponsored by Taiwan Mundipharma Pharmaceuticals Ltd. (part of Mundipharma) · Phase 4, Interventional, and Treatment
This study is to evaluate the efficacy and safety of a titration method by selects 10 mg control-released (CR) oxycodone tablet as background drug in combined with immediate-released (IR) oxycodone, compared to conventional titration method with immediate-released (IR) oxycodone in patients with moderate to severe cancer pain in Taiwan.
This is an interventional, open label, randomized controlled study carrying in multi-centers. Eighty opioid-naive patients with moderate to severe cancer pain (≥ 4) in outpatient department (OPD), who agreed and signed informed consent will be randomly assigned in a 1:1 ratio to receive CR + IR oxycodone or conventional IR oxycodone groups. The study is to compare the titration efficacy and safety of CR with IR oxycodone (experimental group) comparing IR oxycodone (control group) in cancer patients suffered with moderate to severe pain. The study last 14 days. Patients begin the study by the first day visit of the clinic and received the study medication (Baseline). Following visits on cycle 1 (day 3 or 4 depends on the available clinics), cycle 2 (day 7±1), cycle 3 (day 10±1), and cycle 4 (day 14±1). In the experimental group, 10 mg CR oxycodone tablet will be selected as background dose of titration, and patients will be administered once every 12 hrs. Meanwhile, the titration with IR oxycodone will be added according to the pain intensity, e.g. if patient receiving 6 tablets of 10 mg CR oxycodone (giving in Q12H frequency for 3 days), 12 capsules of 5mg IR oxycodone will be dispensed for managing acute pain (rescue use) for the first cycle. In the control group, the conventional titration with IR oxycodone will be conducted according to pain intensity, using 5 mg as initial dose, e.g. 12 capsules of 5mg IR oxycodone (giving in Q6H frequency for 3 days), 12 capsules of 5mg IR oxycodone will be dispensed for rescue use upon to the first cycle. Patient will record their pain score (4 times in Q6H frequency and before taking the drug), 24hr total dose (total tablets/capsule number), number of breakthrough pain and PRN time and dosage used onto the patient diary. The background dose of each patient will be titrated after cycle 1 by investigators. Titration cycles will be recorded and evaluated pain assessments on cycle 2 (day 7±1), cycle 3 (Day 10±1), cycle 4 (day 14±1). During study, the study nurse will follow patient's daily records, drug use condition every second day by telephone or other contact methods to keep close monitor of patient's condition. The telephone contact for cycle 1 and cycle 3 is acceptable for this study. If the telephone contact is conducted for patient, the 1-week quantities of oxycodone should be dispensed to patient.
The safety for individual patient will be followed during study up to end of treatment (EOT) or early termination (ET). All adverse events (AE(s)) and serious adverse events (SAE(s)) occurred during the study period will be followed until resolution or the event is considered stable.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Taiwan Mundipharma Pharmaceuticals Ltd. is the lead sponsor of 5 studies on the registry; none are open to participants now.
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1) ≥ 60 mg of morphine daily 2) ≥25 mcg transdermalfentanyl/hour 3) ≥ 8 mg of oral hydromorphone daily or 4) an equianalgesic dose of another opioid
5) Patients who will not be treated with radiotherapy within 7 days prior to randomization and during study
6) Patients who need chemotherapy, long term administration of hormone, targeted therapy, or bisphosphonates therapy should undergo a stable anti-tumor therapy prior to randomization.
7) Patients or his/her caregivers who are able to fill out the diary and questionnaire forms
Exclusion Criteria:
Control-released oxycodone Q12H, initial daily dose is 20 mg + immediate-released oxycodone for PRN
Drug: Oxycodone
Immediate-released oxycodone Q6H, initial daily dose is 20mg + immediate-released oxycodone for PRN
Drug: Oxycodone
To evaluate the variable change of NRS pain score and the number of breakthrough pain to obtain pain control after treatment
The change from baseline of NRS pain score and the daily number of breakthrough pain
Time frame: Up to 14 days
To evaluate the percentage of patients in each titration cycle
The percentage of patients in each titration cycle
Time frame: Up to 14 days
To evaluate the number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control
The number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control
Time frame: Up to 14 days
The total opioid taken within 24hrs daily from baseline to day 14
The total opioid taken within 24 hrs daily from baseline to day 14
Time frame: Up to 14 days
To evaluate the mean daily NRS score of subjects from baseline to day 14
Mean daily NRS score of patients from baseline to day 14
Time frame: Up to 14 days
To evaluate the total daily rescue dose taken (immediate-released oxycodone capsule) for treatment of breakthrough pain among patients from baseline to day 14
The total daily rescue dose taken (immediate-released oxycodone capsule) for treatment of breakthrough pain among patients from baseline to day 14
Time frame: Up to 14 days
To evaluate the tolerability and safety of Oxycodone CR and IR in cancer pain patient
The occurrence rate of adverse events and physical examination status
Time frame: Up to 28 days
To evaluate the change from baseline in questionnaire
The change from baseline in questionnaire
Time frame: Up to 14 days
Plan to share: Undecided
Ran from Sep 2016 to primary completion in Dec 2018, 27 months.
Of 64 phase 4 interventional studies under Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 85. This study's 27 months is below that.
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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oxycodone
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