Efficacy and Safety Study of Celecoxib and Pregabalin Compared With Celecoxib Monotherapy, in Patients With Chronic Low Back Pain Having a Neuropathic Component

Summary

The purpose of this study is to determine if treatment with celecoxib and pregabalin together would prove to be more effective in relief of pain than treatment with celecoxib alone in people who have chronic low back pain with a probable neuropathic component.

Timeline

Start

2013-10

Primary completion

2015-05

Completion

2015-06

Outcome

Missed primary endpoint

Stopped (Enrollment): “Recruitment terminated on 3Apr2015 due to slow recruitment rate and lack of operational feasibility. Study was not terminated for reasons of safety/efficacy.”

registry analysis (unspecified test); Arm A vs Arm B; p = 0.6012; LS Mean Difference -0.15 (95% CI -0.72 to 0.42); Mixed Models Analysis NCT01838044 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Celecoxib	Other / unclassified	200 mg	—
Subject	Pregabalin	Small molecule	300 mg	—

Indications