A Randomized, Double-blind, Multi-centre Study to Evaluate the Fficacy and Safety of Zometa as a Treatment in Patients With Bone Metastases of Any Solid Tumors or Multiple Myeloma
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Treatment of Bone Metastases
Both
Treatment of Bone Metastases
Trial Information
A Randomized, Double-blind, Multi-centre Study to Evaluate the Fficacy and Safety of Zometa as a Treatment in Patients With Bone Metastases of Any Solid Tumors or Multiple Myeloma
Inclusion Criteria
Inclusion Criteria
- Cancer patients (multiple myeloma or other solid tumors) and confirmed evidence of
bone lesions
- Significant bone pain
Exclusion Criteria
- Poor renal function
- Use of other investigational drugs within 30 days of visit 2
- Dental or other surgery to the jaw within 6 weeks of screening, or planned during the
4 week study
Other protocol-defined exclusion criteria may apply.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
To compare in a randomized fashion the effect of zoledronate and pamidronate 90 mg on pain relief as assessed by pain score after 1-dose treatment in patients with bone pain induced by any solid tumors with bone metastases or Multiple Myeloma
Principal Investigator
Novartis
Investigator Role:
Study Chair
Investigator Affiliation:
Novartis
Authority:
China: Food and Drug Administration
Study ID:
CZOL446E2301
NCT ID:
NCT00219258
Start Date:
July 2005
Completion Date:
Related Keywords:
- Treatment of Bone Metastases
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Neoplasm Metastasis
- Bone Neoplasms
- Bone Marrow Diseases
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