Breakthrough Pain
Conditions
Interventions
1:Phase I: sulfate morphine tablet
Phase II: sulfate morphine supository
2:Phase I: sulfate morphine supository
Phase II: sulfate morphine tablet
Sponsors
Zhongnan Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged = 18 years; 2. Obtain informed consent signed by the patient or authorized client; 3. Compliance is good; 4. Can receive oral or anal treatment separately; 5. ECOG PS score 0-2 points; 6.Survival period = 3 months; 7. Malignant tumor diagnosis is clear; 8. Use opioids to relieve pain, and the basic painkiller dose equivalent to morphine is =60mg within 24 hours before enrollment; 9. Pain control is satisfactory, ie 24 The intranasal pain NRS score = 3 points, the outbreak pain is not more than 3 times; 10. Breakthrough pain happened in the last week; 11. Liver function: with or without liver metastases, ALT and AST = 2.5 normal high value (ULN), bilirubin = 1.5 times ULN; 12. renal function: serum creatinine = 1.5 times ULN, and creatinine clearance = 60ml / min; 13. Take effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Patients with non-cancerous pain, such as non-pathological fractures, myocardial infarction, trauma, etc.; 2. Consciousness disorder, such as paralysis, lethargy, lethargy, or coma; 3. Oral taking medicine difficulties; 4. Perianal lesions Or the anus is closed, such as severe sputum, perianal abscess, anal prolapse, etc.; 5. Poor compliance, especially in the case of abuse of immediate release morphine; 6. Meet any morphine formulation contraindications, including but Not limited to respiratory depression, increased intracranial pressure and craniocerebral injury, bronchial asthma, decompensated lung heart disease, hypothyroidism, cortical insufficiency, enlarged prostate, dysuria and severe liver dysfunction, shock state, bowel Obstruction, etc.; 7. Pregnancy or lactation women; 8. Other investigators believe that should be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy;Efficacy onset time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of complete relieve;acceptance; | — |
Countries
China
Contacts
Public ContactZhang Gong
Zhongnan Hospital of Wuhan University
Outcome results
None listed