MedTrace Logo

Long Term Safety and Efficacy Study of Tanezumab in Japanese Adult Subjects With Chronic Low Back Pain

NCT02725411 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 277

Last updated 2020-08-11

Study results available
· View outcomes & findings →

Summary

This study will investigate the long-term safety and efficacy of a fixed dose of tanezumab 5 mg and 10 mg administered subcutaneously (SC) seven times at 8 week intervals. The primary objective of this study is to evaluate the long term safety of tanezumab 5 mg and 10 mg administrated SC every 8 weeks (7 administrations). In addition, the study will evaluate the long term analgesic efficacy of tanezumab 5 mg and 10 mg SC administered every 8 weeks (7 administrations).

Conditions

  • Low Back Pain

Interventions

DRUG

Celecoxib

Orally administered Celecoxib 100 mg twice daily for 56 weeks

BIOLOGICAL

Tanezumab 5 mg

Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks

BIOLOGICAL

Tanezumab 10 mg

Subcutaneous injection of tanezumab 10 mg every 8 weeks for 56 weeks

DRUG

Placebo for celecoxib

Orally administered the placebo twice daily for 56 weeks

BIOLOGICAL

Placebo for tanezumab

Subcutaneous injection of the placebo every 8 weeks for 56 weeks

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-26
Primary Completion
2019-06-11
Completion
2019-06-11

Countries

  • Japan

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 NCT02725411 on ClinicalTrials.gov