Other

Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee

Clinicaltrials.gov Identifier: 

nct03285646

Trial details

Trial date:
October 30, 2017 - May 5, 2018
Phase:  3
Birth sex
Male and female gender symbols.
Age range
18 Years and Older
Accepts healthy volunteers
No
Condition(s) being studied: 

Chronic Low Back Pain, Osteoarthritis

What is the type of trial? 

Interventional

What is the trial testing? 

Fasinumab, Placebo

How many people are being enrolled? 

63

Trial summary

The primary objective of the study is to evaluate the efficacy of fasinumab in relieving Chronic low back pain (CLBP) as compared to placebo in participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and Osteoarthritis (OA) of the knee or hip when treated for up to 16 weeks. The secondary objectives of the study are: To evaluate the safety and tolerability of fasinumab compared to placebo when participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To characterize the concentrations of fasinumab in serum over time when participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To evaluate the immunogenicity of fasinumab when treated for up to 16 weeks in participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip.

Trial locations

location(s)