A Randomized, Double-Blind Study of the Effect of Bondronat Compared With Zoledronic Acid on Pain in Patients With Malignant Bone Disease Experiencing Moderate to Severe Pain
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Pain;, Bone Neoplasms;, Neoplasm Metastasis
Both
Pain;, Bone Neoplasms;, Neoplasm Metastasis
Trial Information
A Randomized, Double-Blind Study of the Effect of Bondronat Compared With Zoledronic Acid on Pain in Patients With Malignant Bone Disease Experiencing Moderate to Severe Pain
Inclusion Criteria:
- patients with malignant bone disease;
- patients with moderate to severe pain.
Exclusion Criteria:
- patients who have received a bisphosphonate within 3 weeks from the signing of
informed consent;
- patients receiving concurrent investigational therapy, or who have received
investigational therapy within 30 days of the first scheduled day of dosing;
- untreated esophagitis or gastric ulcers;
- recent or pre-scheduled radiotherapy to bone;
- patients who are pregnant or breast-feeding.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Pain, as measured by Brief Pain Inventory and analgesic use
Outcome Time Frame:
Week 24
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
BO18039
NCT ID:
NCT00099177
Start Date:
August 2005
Completion Date:
January 2007
Related Keywords:
- Pain;
- Bone Neoplasms;
- Neoplasm Metastasis
- Bone Diseases
- Bone Neoplasms
- Neoplasms
- Neoplasm Metastasis
Name | Location |
|---|---|
| Albany, Georgia 31701 | |
| Miami, Florida 33176 | |
| Austin, Texas 78705 |
