Trial intelligence / Profile preview

Duloxetine effects on brain morphometry in knee osteoarthritis

NCT01558700Phase 4

Key facts

Status
Completed
Start
Mar 2012
Primary completion
Apr 2014
Countries
1
Sponsor
Northwestern University
Modality
Small Molecules
Conditions
osteoarthritis (OA)
01

Overview

Phase 4, randomised, double-blind trial of duloxetine in osteoarthritis (OA) (2 arms), sponsored by Northwestern University. Primary endpoint: Change in Brain Gray Matter Volume at 16 weeks. Started Mar 2012; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Duloxetine

    Duloxetine 30mg/day (1 wk) -> 60mg/day (15 wks) -> 30mg/day (1 wk)

  • Sugar pill

    Matching placebo capsule once daily for 17 weeks

03

Who it enrols

Patients 45-80 years old with knee OA for at least 12 months and VAS pain >5/10. Excludes diabetes, major depressive disorder, and MRI contraindications.

04

Endpoints

Primary

  • Change in Brain Gray Matter Volume

Secondary

  • Change in Pain Magnitude

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