Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Phase II Trial Evaluating Activity and Tolerability of Fixed Dose of Oxycodone and Increasing Dose of Pregabalin Versus Increasing Dose of Oxycodone and Fixed Dose of Pregabalin for the Treatment of Oncological Neuropathic Pain
Brief Summary: The aim of the study is to assess tolerability and activity of oxycodone and pregabalin in combination for the treatment of oncological neuropathic pain with two different strategies.


Options:
A: Inclusion Criteria:

* patients with diagnostic (histological or cytological) evidence of locally advanced or metastatic solid tumour;
* with average pain intensity ≥ 4, measured with NRS and related to the last 24 hours, due to the cancer, requiring for the first time an analgesic treatment with 3rd step/WHO opioids
* with life expectancy \> one month
* "strong" opioid naïve;
* eligible to take any of the medications under evaluation, by TDS or by mouth;
* with age ≥ 18 years;

Exclusion Criteria:

* Patients recruited in other researches that conflict or may confound the conduction and results of the present study;
* Lack of informed consent;
* with presence of other diseases, including psychiatric/mental illness, severe senile or other form of dementia, that can interfere with participation and compliance with the study protocol or can contraindicate the use of the investigational drugs;
* with presence of co-morbidities, which could create potentially dangerous drug interactions with opioids (eg, use of macrolide antibiotics or antifungal,....);
* any kind of contraindications to the use of opioid drugs;
* Patients with a known story, past or current, of drugs abuse or addiction;
* Use of drugs which presents a combination of opioids and other molecule (as NSAIDs, paracetamol, naloxone, ..);
* Patients who cannot guarantee regular follow-up visits for logistic or geographic reasons;
* Need of starting 3rd step treatment in an "emergency clinical situation" that do not allow the correct procedures of randomization;
* diagnosis of primary brain tumor or leukaemia;
* diagnosis of chronic renal failure;
* patients with antalgic radiotherapy or radio-metabolic therapy in progress or completed less than 14 days before study;
* patients starting a first line chemotherapy simultaneously to the beginning of the study;
* other types of analgesic treatments, including local-regional anesthetic techniques or neurosurgical /ablative methods.
B: Inclusion Criteria:

* instrumental and clinical diagnosis of every malignant neoplasm
* presence of pain with a neuropathic component in the opinion of the physician
* presence of pain \>=4(NRS)
* PS ECOG \<3
* written informed consent

Exclusion Criteria:

* serum creatinine \>2mg/ml or creatinine clearance \<40 ml/min
* mild or severe hepatic insufficiency
* iatrogenic neuropathy caused by chemotherapeutic agents
* previous allergic reactions to oxycodone and pregabalin
* pregnancy or breastfeeding
C: Inclusion Criteria:

* Documented clinical diagnosis of any type of cancer
* Diagnosis of chronic malignant tumor-related cancer pain with an average score for pain intensity in the past 24 hours of \>=4 on the 11-point numerical rating scale (NRS) on the day of randomization (Day -1)
* Have not received treatment with opioid analgesics within 28 days before screening (Note: codeine phosphate \[\<=60 mg/d\] or dihydrocodeine phosphate \[\<=30 mg/d\] for antitussive use are allowed)
* Dissatisfied with pain relief by the current treatment and for whom the investigator or designee judges that treatment with opioid analgesics is required

Exclusion Criteria:

* Have complicated with uncontrolled/clinically significant arrhythmia
* Have previous or concurrent presence of any disease which may develop increased intracranial pressure, disturbance of consciousness, lethargy, or respiratory problems such as traumatic encephalopathy with cerebral contusion, intracranial hematoma, disturbance of consciousness, brain tumor, cerebral infarction, transient ischemic attack, epilepsy or convulsive diseases
* Have history of alcohol and/or drug abuse
* Have any disease for which opioids are contraindicated such as serious respiratory depression of serious chronic obstructive pulmonary disease, bronchial asthma attack, cardiac failure secondary to chronic pulmonary disease, paralytic ileus, status epileptics, tetanus, strychnine poisoning, acute alcohol poisoning, hypersensitivity to opium alkaloid, hemorrhagic colitis, or bacterial diarrhea
D: Inclusion Criteria:

* Chronic Uncontrolled Pain That Required Stronger Opioid Therapy Than They Have Been Taking
* Histologically Confirmed Solid Cancer
* Aged Over 18 Years
* Admitted in a Palliative Cancer Care Unit

Exclusion Criteria:

* Uspected to Have Narcotic Abuse, Clinically Relevant CO2 Retention or Had an Active Skin Disease
* Inability to swallow oral medication, and impaired sensory or cognitive function
* Patients who had an active infection, uncontrolled central nervous system involvement, or on antitumor therapy of any kind

Answer: B