Trials / Completed
CompletedNCT02609828
Phase 3 Study on the Efficacy and Safety of Tanezumab in Patients With Cancer Pain Due to Bone Metastasis Who Are Taking Background Opioid Therapy
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB (PF-04383119) IN SUBJECTS WITH CANCER PAIN PREDOMINANTLY DUE TO BONE METASTASIS RECEIVING BACKGROUND OPIOID THERAPY
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 156 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether tanezumab is effective in the treatment of cancer pain due to bone metastasis in patients already taking background opioid therapy.
Detailed description
This is a randomized, double-blind, placebo-controlled, multicenter, parallel-group Phase 3 study in cancer subjects requiring treatment with background opioids for pain due to bone metastasis. Approximately 144 subjects will be randomized to one of 2 treatment groups in a 1:1 ratio (approximately 72 subjects per group). Subjects will receive a total of 3 subcutaneous injections, separated by 8 weeks in addition to background opioids administered throughout the study. Treatment groups will include: 1. Placebo SC (matching tanezumab SC) in addition to background opioid therapy. 2. Tanezumab 20 mg SC in addition to background opioid therapy. The study consists of three periods: Pre-Treatment (up to 37 days), Double-Blind Treatment (24 weeks) and Safety Follow-up (24 weeks).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tanezumab | Subcutaneous study treatment (tanezumab 20 mg or matched placebo) dosed at 8 week intervals. |
Timeline
- Start date
- 2015-10-28
- Primary completion
- 2020-09-17
- Completion
- 2021-06-25
- First posted
- 2015-11-20
- Last updated
- 2023-02-16
- Results posted
- 2023-01-20
Locations
89 sites across 16 countries: Argentina, Australia, Austria, Brazil, Chile, China, Czechia, Hungary, Israel, Japan, Poland, Romania, Slovakia, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02609828. Inclusion in this directory is not an endorsement.