Brain Morphometry in OA Patients Treated With Duloxetine

Pain Clinical Trial

Official title:

Brain Morphometric Study in Knee Osteoarthritis Patients Treated With Duloxetine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02903238
• Other study ID #: STU00039556A
• Status: Completed
• Phase: N/A
• First received: August 26, 2016
• Last updated: September 15, 2016
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: September 2016
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a two week,single-blind study evaluating pain response and changes in brain imaging upon treatment with placebo in people with knee OA.

Description:

In this study, all the participants will be receiving placebo. However this study will be single blinded in that participants will be told that they will be given a pill that may or may not help with their pain. The researcher, however, will know that all participants are receiving placebo

At the initial visit, participants will undergo screening to determine that they meet all inclusion and exclusion criteria. They will sign consent and then complete pain assessment instruments as well as one high resolution anatomical scan (T1) and one functional scan (a resting scar) in a 3 Tesla magnet. A single scanning session comprised of a 10 minute functional scan (a resting scan) will be done two weeks from the first scan and pain assessment instruments will be completed at this visit as well. After finishing this second scan (done two weeks after the initial scan), the participants will have completed the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age: 40-85 years

• ACR criteria for OA including Kellgren-Lawrence radiographic OA grades II-IV

• VAS pain score >5/10 within 48 hrs of the phone screen and visit 1 (Screening)

• Knee OA for a minimum of 12 months

• Need for daily pain medication to manage symptoms of OA

Exclusion Criteria:

• Currently taking MAO inhibitors or any centrally acting drug for analgesia

• Narrow angle glaucoma

• Uncontrolled hypertension

• Co-existing inflammatory arthritis, fibromyalgia or other chronic pain state

• If a female, pregnant, trying to become pregnant, or lactating

• Major depressive disorder

• Substantial alcohol use or history of significant liver disease

• Diabetes, type 1 or type 2

• Condition in which the Investigator believes would interfere with the subject's ability to comply with study instructions, or might confound the interpretation of the study results or put the subject at undue risk

• Standard MRI safety exclusions

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Osteoarthritis
• Pain

Intervention

Drug:
• placebo
lactose containing capsule

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain regional gray matter density		2 weeks	No
Secondary	WOMAC pain index		2 weeks	No
Secondary	Overall brain neocortical gray matter volume		2 weeks	No