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| Sponsored by: |
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 comination with opioids in treating pain due to cancer that has spread to bone.
| Condition | Intervention | Phase |
|
Palliative Care Neoplasm Metastasis |
Drug: Tanezumab 10 mg IV Drug: IV Placebo for tanezumab |
Phase II |
| MedlinePlus related topics: | Cancer Palliative Care |
| Drug Information available for: | BaseLine |
| 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: | October 2008 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 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 |
| United States, Arizona | |||||
| Pfizer Investigational Site | |||||
| Litchfield Park, Arizona, United States, 85340 | |||||
| Pfizer Investigational Site | |||||
| Sun City, Arizona, United States, 85351 | |||||
| United States, California | |||||
| Pfizer Investigational Site | |||||
| Antioch, California, United States, 94509 | |||||
| Pfizer Investigational Site | |||||
| Walnut Creek, California, United States, 94598 | |||||
| Pfizer Investigational Site | |||||
| San Leandro, California, United States, 94578 | |||||
| Pfizer Investigational Site | |||||
| Concord, California, United States, 94520 | |||||
| United States, New Jersey | |||||
| Pfizer Investigational Site | |||||
| Hackensack, New Jersey, United States, 07601 | |||||
| Pfizer Investigational Site | |||||
| Teaneck, New Jersey, United States, 07666 | |||||
| United States, Ohio | |||||
| Pfizer Investigational Site | |||||
| Middletown, Ohio, United States, 45042 | |||||
| United States, South Carolina | |||||
| Pfizer Investigational Site | |||||
| Myrtle Beach, South Carolina, United States, 29572 | |||||
| United States, Texas | |||||
| Pfizer Investigational Site | |||||
| Beaumont, Texas, United States, 77701 | |||||
| United States, Utah | |||||
| Pfizer Investigational Site | |||||
| Ogden, Utah, United States, 84403-3274 | |||||
| Pfizer |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
To obtain contact information for a study center near you, click here. 
  |
| Responsible Party: | Pfizer Inc. ( Director, Clinical Trials Disclosure Group ) |
| Study ID Numbers: | A4091003 |
| First Received: | October 15, 2007 |
| Last Updated: | November 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00545129 |
| Health Authority: | United States: Food and Drug Administration |
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