NCT00945945

A Phase 3b Study to Assess the Efficacy of Duloxetine 60 mg Once Daily Compared With Placebo on the Reduction of Pain Caused by Osteoarthritis of the Knee, in a 13-week, Double-blind, Randomized Study

Completed Phase 3 Results posted Last updated 11 February 2011

What this trial tests

Phase 3 trial testing Duloxetine (DLX) in Osteoarthritis Knee Pain in 424 participants. Completed in 1 May 2010.

Timeline

1 July 2009

Primary endpoint
1 May 2010

1 May 2010

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	424
Start date	1 July 2009
Primary completion	1 May 2010
Estimated completion	1 May 2010
Sites	26 locations across United States, Germany, Greece, Puerto Rico, Romania, Russia, Spain, Sweden

Drugs / interventions tested

• Duloxetine (DLX) — full drug profile →
• Placebo (PLA) — full drug profile →

Conditions studied

• Osteoarthritis Knee Pain — all drugs for Osteoarthritis Knee Pain →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

40 and older, any sex, with Osteoarthritis Knee Pain. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change From Baseline to 13 Week Endpoint (Baseline Observation Carried Forward [BOCF]) in Brief Pain Inventory (BPI) "24-Hour Average Pain" Item (Question 3) of the BPI-Modified Short Form Score
  Time frame: Baseline, 13 weeks
  A self-reported measure of the severity of pain based on the average pain over 24-hours. Severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). BOCF endpoint was defined as the baseline value for participants discontinued during acute phase, and defined as the last non-missing observation in the treatment phase for all other randomized participants. Due to the nature of

Sponsor's own description

The primary purpose of this study is to determine if duloxetine 60 mg once daily (QD) reduces pain severity in patients with osteoarthritis (OA) knee pain compared with placebo.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Antidepressants for pain management in adults with chronic pain: a network meta-analysis.
   Birkinshaw H, Friedrich CM, Cole P, Eccleston C, et al · · 2023 · cited 89× · PMID 37160297 · DOI 10.1002/14651858.cd014682.pub2