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A Phase 3 Study of Tanezumab for Chronic Low Back Pain

NCT02528253 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1832

Last updated 2020-02-21

Study results available
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Summary

This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. In addition, the study will evaluate the effectiveness and long term safety profile of tanezumab treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain.

Conditions

  • Low Back Pain

Interventions

BIOLOGICAL

Placebo to Week 16; tanezumab 5mg SC

Placebo SC injection every 8 weeks for 2 injections followed by tanezumab 5 mg injection every 8 weeks for 5 injections

BIOLOGICAL

Placebo to Week 16, tanezumab 10 mg SC

Placebo SC injection every 8 weeks for 2 injections, followed by tanezumab 10 mg SC injection for 5 injections

BIOLOGICAL

Tanezumab 5 mg SC

Tanezumab 5 mg SC

BIOLOGICAL

Tanezumab 10 mg SC

Tanezumab 10 mg SC

BIOLOGICAL

Tramadol PR oral

Tramadol PR oral

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-18
Primary Completion
2017-10-17
Completion
2018-12-20
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Denmark
  • France
  • Hungary
  • Japan
  • South Korea
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02528253 on ClinicalTrials.gov