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A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
La Jolla, California, 92037-7651 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasm Metastasis, Palliative Care
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00545129
Pfizer
Completed
A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone

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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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Neoplasm Metastasis
  • Palliative Care
  • Drug: Tanezumab 10 mg IV
    Single IV infusion of 10 mg 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.
  • Experimental: Tanezumab 10 mg IV + opioids
    Intervention: Drug: Tanezumab 10 mg IV
  • Placebo Comparator: Placebo + opioids
    Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.
    Intervention: Drug: IV Placebo for tanezumab


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
February 2012
December 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Bosnia and Herzegovina,   Croatia,   France,   Hungary,   India,   Korea, Republic of,   Latvia,   Mexico,   Peru,   Poland,   Slovakia,   United States
Hong Kong
 
NCT00545129
A4091003
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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