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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasm Metastasis, Palliative Care

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change from Baseline to Week 6 in daily average pain intensity measured by the 11 point Pain Intensity Numerical Rating Scale (NRS; 0-10). Baseline is the average daily Pain NRS score during Stabilization Phase prior to Randomization (3 days).

Outcome Time Frame:

16 weeks

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4091003

NCT ID:

NCT00545129

Start Date:

April 2009

Completion Date:

February 2012

Related Keywords:

  • Neoplasm Metastasis
  • Palliative Care
  • Neoplasms
  • Neoplasm Metastasis

Name

Location
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Carmel, Indiana  46032
Pfizer Investigational Site Easley,, South Carolina  29640
Pfizer Investigational Site Shreveport, Louisiana  71103
Pfizer Investigational Site Salt Lake City, Utah  84112