Format

Send to

Choose Destination
See comment in PubMed Commons below
Eur J Neurol. 2009 Sep;16(9):1041-8. doi: 10.1111/j.1468-1331.2009.02648.x. Epub 2009 May 12.

A double-blind, randomized trial of duloxetine versus placebo in the management of chronic low back pain.

Author information

1
Lilly Research Laboratories, Indianapolis, IN, USA. vladimir@lilly.com

Abstract

BACKGROUND:

Duloxetine has demonstrated analgesic effect in chronic pain states. This study assesses the efficacy of duloxetine in chronic low back pain (CLBP).

METHODS:

Adult patients with non-radicular CLBP entered this 13-week, double-blind, randomized study comparing duloxetine 20, 60 or 120 mg once daily with placebo. The primary measure was comparison of duloxetine 60 mg with placebo on weekly mean 24-h average pain. Secondary measures included Roland-Morris Disability Questionnaire (RMDQ-24), Patient's Global Impressions of Improvement (PGI-I), Brief Pain Inventory (BPI), safety and tolerability.

RESULTS:

Four hundred four patients were enrolled, 267 completed. No significant differences existed between any dose of duloxetine and placebo on reduction in weekly mean 24-h average pain at end-point. Duloxetine 60 mg was superior to placebo from weeks 3-11 in relieving pain, but not at weeks 12-13. Duloxetine 60 mg demonstrated significant improvement on PGI-I, RMDQ-24, BPI-average pain and BPI-average interference. Significantly more patients taking duloxetine 120 mg (24.1%) discontinued because of adverse events, versus placebo (8.5%).

CONCLUSIONS:

Duloxetine was superior to placebo on the primary objective from weeks 3-11, but superiority was not maintained at end-point. Duloxetine was superior to placebo on many secondary measures, and was well-tolerated.

[Indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Wiley
    Loading ...
    Support Center