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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00545129 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasm Metastasis Palliative Care |
Drug: Tanezumab 10 mg IV Drug: IV Placebo for tanezumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 58 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Tanezumab 10 mg IV + opioids: Experimental |
Drug: Tanezumab 10 mg IV
Single IV infusion of 10 mg tanezumab on Day 1. Maintained on baseline opioid regimen.
|
|
Placebo + opioids: Placebo Comparator
Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.
|
Drug: IV Placebo for tanezumab
Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Show 30 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer Inc. ( Director, Clinical Trials Disclosure Group ) |
| Study ID Numbers: | A4091003 |
| Study First Received: | October 15, 2007 |
| Last Updated: | January 15, 2010 |
| ClinicalTrials.gov Identifier: | NCT00545129 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Physiological Effects of Drugs Central Nervous System Depressants Pharmacologic Actions Neoplasms Neoplastic Processes Pathologic Processes Sensory System Agents |
Therapeutic Uses Neoplasm Metastasis Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |