Phase
Condition
Cancer Pain
Pain
Acute Pain
Treatment
N/AClinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 years old or more;
ECOG PS ≤3 ;
Opioid tolerance not moderate pain patients (4≤ NRS ≤6 on 11 points, 0 no pain, 10most pain);
No taking strong opioids for the last 30 days;
Estimated life expectancy of at least 3 months;
Ability to communicate effectively with the study personnel about the nature of theirpain;
Ability to complete a diary;
Cancer pain is expected to be relatively stable and last for more than 48 hours;
The patient understands the research process, agrees to participate in the trial,cooperates with the treatment and visit plan, and signs an informed consent form.
Exclusion
Exclusion Criteria:
Known allergy to any ingredient in both fentanyl and morphine;
No cancer associated pain or the pain of unknown cause, such as osteoarthritis pain,acute abdominal pain;
Primary tumors or metastases in the brain;
An active skin disease that precluded application of the transdermal system;
Anti-cancer therapy (radiotherapy, chemotherapy, targeted therapy, etc.) is usedduring the study period, and the treatment has an impact on the analgesic effect oradverse reactions of analgesic drugs;
No bowel movement within 3 days before the screening period;
The patient has contraindications to the use of opioids: such as respiratorydepression; head damage; paralytic intestinal obstruction; acute abdomen; chronicobstructive airway disease; pulmonary heart disease; chronic bronchial asthma;hypercapnia;
Used monoamine oxidase inhibitor within 1 week before randomization;
Any abnormal laboratory test results with obvious clinical significance, such ascreatinine value ≥ 2 times the high limit of the normal value or ALT or AST ≥ 2.5times the high limit of the normal value (for patients with liver metastases can berelaxed to ≥ 5 times the high limit of the normal value) ;
Patients with a history of drug abuse;
Patients with mental illness or cognitive impairment;
Pregnant or lactating women; subjects who have a pregnancy plan within 1 month afterthe test (including male subjects);
Participate in the drug trial (including the trial drug) within 3 months before thetrial.