Moderate to severe cancer pain
Conditions
Interventions
Trial group:Subjects in the trial group receive one dose in the morning (hydromorphone hydrochloride sustained-release tablets + placebo tablets of oxycodone hydrochloride sustained-release tablets) a
Control group:Subjects in the control group receive one dose in the morning (oxycodone hydrochloride sustained-release tablets + placebo tablets of hydromorphone hydrochloride sustained-release tablet
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years old, gender not limited; 2.Diagnosed as malignant tumor through histopathological or cytological examination; 3.Expected survival period >= 12 weeks; 4.ECOG physical condition score = 40mg) to control moderate to severe cancer pain; 7.Voluntarily participate in this experiment and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals with abnormal blood routine and hematological liver and kidney function tests: Abnormal blood routine: neutrophil count (ANC) = 2.5 × ULN, liver cancer or liver metastasis >= 5 times ULN; Abnormal renal function: serum creatinine>1.5 × ULN and eGFR<60mL/min/1.73m^2; 2.Patients allergic to hydromorphone, hydrocodone, and morphine; 3.Patients with unexplained pain (unable to determine the mechanism or physiological cause), pain only during activity, or acute pain; 4.Patients with obvious gastrointestinal dysfunction symptoms, such as inability to swallow, uncontrollable nausea and vomiting, chronic diarrhea, intestinal obstruction, etc., or those who may affect the intake, transportation, or absorption of drugs, within 2 weeks before signing the informed consent form; 5.Individuals with the following symptoms or diseases that the researcher deems unsuitable to participate in the trial: prostate enlargement, thyroid dysfunction, urethral stricture symptoms, traumatic brain injury, cerebral aneurysm, asthma, respiratory obstruction; 6.Patients with symptoms of intracranial hypertension, asthma attacks, or respiratory failure; 7.Patients who have used monoamine oxidase inhibitors (such as isoniazid, isopropylhydrazine, and oxytetracycline) within 14 days before or during medication; 8.Patients who have taken or need to take the following medications within 7 days before or during the medication period; Partial opioid receptor agonists/antagonists: such as buprenphine, nalbuphine, and pentazocine; Alcohol and other anesthetics (such as ketamine); Muscle relaxants: such as rocuronium bromide and vecuronium bromide 9.Patients who start using fentanyl transdermal patches within 72 hours before taking medication; 10.Patients who require the use of other opioid analgesics (excluding morphine immediate release preparations) during medication; 11.Screening for alcohol abuse history within the past 6 months: Alcoholism: Within the 6 months prior to the start of the experiment, frequently consumed alcohol, with an average of over 14 units of alcohol per week (1 unit=360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); 12.Pregnant or lactating women or patients with fertility plans within 3 months (including males); 13.Patients who have participated in any clinical trials within 30 days prior to taking medication; 14.Researchers believe that patients who are not suitable to participate in the trial due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the rating for the most severe pain in the past 24 hours;Changes in the average severity score of pain over the past 24 hours;The change in pain level rating at this moment;Changes in pain relief scores within the past 24 hours;Changes in the rating of the lightest degree of pain in the past 24 hours;BTP remediation frequency;The time to reach a stable dose for pain control (titration period duration);The satisfaction of the subjects with pain treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event;Serious Adverse Event;Complete Blood Count;Blood Biochemistry Panel;Coagulation Profile;Urinalysis;Physical Examination;Body Temperature;Respiratory Rate;Oxygen Saturation (SpO?);Blood Pressure;12-Lead Electrocardiogram (ECG); | — |
Countries
China
Contacts
Public ContactLuo Suxia
Henan Cancer Hospital
Outcome results
None listed