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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 November 21, 2019

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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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Descriptive Information
Brief Title  ICMJE A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Neoplasm Metastasis
  • Palliative Care
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications *


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2012)
59
Original Enrollment  ICMJE
 (submitted: October 16, 2007)
150
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion DateDecember 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Bosnia and Herzegovina,   Croatia,   France,   Hungary,   India,   Korea, Republic of,   Latvia,   Mexico,   Peru,   Poland,   Slovakia,   United States
Removed Location CountriesHong Kong
 
Administrative Information
NCT Number  ICMJE NCT00545129
Other Study ID Numbers  ICMJE A4091003
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2013

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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