A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone
Phase 2
Completed
- Conditions
- Health Condition 1: null- Neoplasm MetastasisPalliative Care
- Registration Number
- CTRI/2011/05/001754
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 58
Inclusion Criteria
1.Prostate cancer, breast cancer, renal cell carcinoma or multiple myeloma that has spread to bone, causing moderate to severe bone pain.
2.Requires daily opioid medication
Note: there is no upper age limit for inclusion criteria for this trial
Exclusion Criteria
1.Patients who do not have bone pain caused by cancer are not eligible for the study.
2.Patients who started chemotherapy less than 4 weeks ago, or who completed radiotherapy less than 4 weeks ago, are not eligible.
3.Known history or evidence of osteoarthritis. History of significant trauma to a major joint within 1 year prior to Screening.
4.Known history of rheumatoid arthritis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline to Week 6 in daily average pain intensity measured by the 11 point Pain Intensity Numerical Rating Scale (NRS; 0-10). Baseline is the average daily Pain NRS score during Stabilization Phase prior to Randomization (3 days).Timepoint: 16 weeks
- Secondary Outcome Measures
Name Time Method