Clinical trial · Interventional
A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone
PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER EFFICACY AND SAFETY STUDY OF TANEZUMAB AS ADD-ON THERAPY TO OPIOID MEDICATION IN PATIENTS WITH PAIN DUE TO BONE METASTASES
NCT00545129CI-TRIAL-00052322completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to investigate the safety and efficacy of tanezumab in combination with opioids in treating pain due to cancer that has spread to bone.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Metastasis | — | UNRESOLVED | — |
| Palliative Care | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IV Placebo for tanezumab | Drug | — | UNRESOLVED |
| Tanezumab 10 mg IV | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tanezumab 10 mg IV + opioids
- interventionNames
- Drug: Tanezumab 10 mg IV
- type
- PLACEBO_COMPARATOR
- label
- Placebo + opioids
- description
- Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.
- interventionNames
- Drug: IV Placebo for tanezumab
Primary outcomes (1)
- measure
- Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Week 6
- timeFrame
- Baseline, Week 6
- description
- Daily average pain was assessed on an 11-point NRS over the past 24 hours (before each specified visit), where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Lower the score, lesser the pain intensity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Prostate cancer, breast cancer, renal cell carcinoma or multiple myeloma that has spread to bone, causing moderate to severe bone pain. * Requires daily opioid medication Exclusion Criteria: * Patients who do not have bone pain caused by cancer are not eligible for the study. * Patients who started chemotherapy less than 4 weeks ago, or who completed radiotherapy less than 4 weeks ago, are not eligible. * Known history or evidence of osteoarthritis. History of significant trauma to a major joint within 1 year prior to Screening. * Known history of rheumatoid arthritis.
References
Publications (2)
- DERIVEDSopata M, Katz N, Carey W, Smith MD, Keller D, Verburg KM, West CR, Wolfram G, Brown MT. Efficacy and safety of tanezumab in the treatment of pain from bone metastases. Pain. 2015 Sep;156(9):1703-1713. doi: 10.1097/j.pain.0000000000000211. PMID 25919474
- DERIVEDBapat AA, Hostetter G, Von Hoff DD, Han H. Perineural invasion and associated pain in pancreatic cancer. Nat Rev Cancer. 2011 Sep 23;11(10):695-707. doi: 10.1038/nrc3131. PMID 21941281