CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,832 enrolled
Drug / intervention
Placebo to Week 16; tanezumab 5mg SC +4 morebiological
Likely dose
Placebo to Week 16; tanezumab 5mg SCfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02528253
NCT02528253Phase 3Completed
CompareCT.gov

A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN

Pfizer·interventional·Posted Aug 19, 2015·Updated Feb 21, 2020

In Brief

A Phase 3 clinical trial evaluating Placebo to Week 16; tanezumab 5mg SC, Placebo to Week 16, tanezumab 10 mg SC, and 3 other interventions for Low Back Pain. Completed, enrolled 1,832 participants across 262 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesCanada, Denmark, France, Hungary, Japan, South Korea, Spain, Sweden, United States
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 19, 2015
Enrollment StartAug 18, 2015
Primary CompletionOct 17, 2017
Study CompletionDec 20, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.9 years ago

Interventions

Placebo to Week 16; tanezumab 5mg SCbiological

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

Placebo to Week 16, tanezumab 10 mg SCbiological

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

Tanezumab 5 mg SCbiological

Tanezumab 5 mg SC

Tanezumab 10 mg SCbiological

Tanezumab 10 mg SC

Tramadol PR oralbiological

Tramadol PR oral