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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
Not Enrolling
Both
Pain;, Bone Neoplasms;, Neoplasm Metastasis

Thank you

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