This is a randomized, double-blind, placebo-controlled Phase Ib study evaluating the safety and efficacy of VC004 capsules for the relief of moderate-to-severe pain associated with bone metastases
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Participants must understand and voluntarily sign the informed consent form (ICF);
2. Male or female, aged ≥ 18 years;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
4. Life expectancy of ≥ 12 weeks, as assessed by the investigator;
5. The participant is able to communicate well with the investigator, and is willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion Criteria:
1. The participant's pain is associated with oncologic emergencies, such as intestinal obstruction/perforation, spinal cord compression, epidural metastasis, or fracture or impending fracture of weight-bearing bones;
2. The participant has known or suspected unstable brain metastases or leptomeningeal metastases;
3. History of severe alcohol, analgesic, or narcotic drug abuse within 6 months prior to screening;
4. Major surgery within 3 months prior to screening, or planned major surgery during the study period;
5. Female participants who are planning to become pregnant, are pregnant, or are breastfeeding; or participants who are unwilling or unable to use effective contraception throughout the entire study period and for 3 months after the end of the study;
6. Any other condition that, in the opinion of the investigator, would make the participant unsuitable for participation in this study.
Primary outcome measure(s)
Change from baseline in the daily average pain intensity Numeric Rating Scale (NRS) score — At Week 1, Week 2 and Week 4
Trial sites (2)
Facility
City
Region
Status
Zhongda Hospital,Affiliated to Southeast University
Nanjing
Jiangsu
Zhongda Hospital,Affiliated to Southeast University
Nanjing
Jiangsu
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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