A Pilot Trial of Intravenous (IV) Pamidronate for Low Back Pain
NCT00101790 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2010-01-07
Summary
The purpose of this study is to determine the test dose of pamidronate for treatment of low back pain in terms of safety, tolerability, and pain relief.
Conditions
- Low Back Pain
Interventions
- DRUG
-
pamidronate
There will be four study groups, each with 7 subjects randomly assigned to pamidronate and 4 to placebo. The groups will occur in succession, not parallel. The dosage for group 1 will be 30 mg , 60 mg for group 2, and 90 mg for group 3. Group 4 will receive 2 treatments of 90mg IV pamidronate or placebo.
Sponsors & Collaborators
-
National Institute of Neurological Disorders and Stroke (NINDS)
collaborator NIH -
Icahn School of Medicine at Mount Sinai
lead OTHER
Principal Investigators
-
Marco Pappagallo, MD · The Mount Sinai Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-09-30
- Primary Completion
- 2010-06-30
- Completion
- 2010-06-30
Countries
- United States
Study Locations
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