Effect of Duloxetine 60 mg Once Daily versus Placebo in Patients with Chronic Low Back Pai

Phase 3

Completed

Conditions: chronische lage rugpijn
chronic low back pain

Registration Number: NL-OMON32370

Lead Sponsor: Eli Lilly

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Male or female outpatients at least 18 years of age with a clinical diagnosis of chronic low back pain. Pain must be present on most days for at least 6 months.

Exclusion Criteria

Patients with a history of more than 1 low back surgery or history of low back surgery within 12 months prior to study entry. Patients that have received epidural steroids, facet block, nerve block or other invasive procedures aimed to reduce low back pain within 1 month prior to the study. May not have any previous diagnosis of psychosis, bipolar disorder or schizoaffective disorder.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to assess the efficacy of duloxetine 60<br /><br>mg once daily (QD) compared with placebo on the reduction of pain severity as<br /><br>measured by the Brief Pain Inventory (BPI) 24-hour average pain score in<br /><br>patients with chronic low back pain (CLBP) during a 12-week, double-blind<br /><br>treatment period. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary gatekeeper objectives are:<br /><br>• to evaluate duloxetine 60 mg QD versus placebo on patients* perceived<br /><br>improvement as measured by Patient*s Global Impressions of Improvement (PGI-<br /><br>Improvement) (Guy 1976)<br /><br>• to evaluate duloxetine 60 mg QD versus placebo on the improvement of<br /><br>functioning as measured by the Roland Morris Disability Questionnaire (RMDQ-24)<br /><br>(Roland and Morris 1983).</p><br>