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Inhibition of oral administration of Bulleyaconitin A on morphine tolerance in patients with advanced cancer pain: a multicenter, randomized, double blind, controlled trial based on Implantable Drug Delivery System

Inhibition of oral administration of Bulleyaconitin A on morphine tolerance in patients with advanced cancer pain: a multicenter, randomized, double blind, controlled trial based on Implantable Drug Delivery System

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039539
Enrollment
Unknown
Registered
2020-10-30
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced cancer pain

Interventions

Experimental Group:oral administration of Bulleyaconitin A+IDDS
Placebo Group:Placebo+IDDS

Sponsors

The First Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. With diagnosis of terminal cancer carcinoma by histology or cytology; 2. Control the pain score to VAS = 18 years; 4. Expected survival >= 3 months; 5. Informed consent form signed.

Exclusion criteria

Exclusion criteria: 1. Bulleyaconitin A allergy; 2. Brain tumor and leukemia; 3. Pregnant and lactating women; 4. Concurrent radiotherapy was performed, and first-line chemotherapy was randomly assigned 7 days before; 5. Complications requiring surgical intervention; 6. Patients with postherpetic pain, trigeminal neuralgia, and diabetic neuralgia; 7. Organ transplant recipients; 8. With history of severe organ diseases, such as heart, lung, liver; 9. Active clinical severe infection; 10. Opioid abusers; 11. Schizophrenia or psychiatric substance abuse; 12. Unable to take oral medicine; 13. Participating in clinical trials of other analgesics.

Design outcomes

Primary

MeasureTime frame
Growth rate of morphine consumption;

Secondary

MeasureTime frame
Average VAS score over 28 days;Drug toxicity evaluation;Constipation score of PAC-SYM;Pruritus score of WI-NRS;Sedation scores of RASS;Quality of life (QLQ-C30, V3.0);

Countries

China

Contacts

Public ContactXia Feng

The First Affiliated Hospital, Sun Yat-Sen University

fengxia@mail.sysu.edu.cn+86 13688877856

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026