Duloxetine in Osteoarthritis (OA) Pain

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Apkar Apkarian, Northwestern University
ClinicalTrials.gov Identifier:
NCT01558700
First received: March 16, 2012
Last updated: December 16, 2014
Last verified: December 2014
Results First Received: December 5, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Osteoarthritis
Interventions: Drug: Duloxetine
Drug: Sugar pill

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Duloxetine

Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.

Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.

Sugar Pill

Matching capsule given once a day for a total of 17 weeks.

Sugar pill: Matching capsule given once a day for a total of 17 weeks.


Participant Flow:   Overall Study
    Duloxetine     Sugar Pill  
STARTED     19     21  
COMPLETED     19     21  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Duloxetine

Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.

Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.

Sugar Pill

Matching capsule given once a day for a total of 17 weeks.

Sugar pill: Matching capsule given once a day for a total of 17 weeks.

Total Total of all reporting groups

Baseline Measures
    Duloxetine     Sugar Pill     Total  
Number of Participants  
[units: participants]
  19     21     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     15     16     31  
>=65 years     4     5     9  
Age  
[units: years]
Mean (Standard Deviation)
  58.6  (4.2)     58.9  (8.6)     58.7  (6.5)  
Gender  
[units: participants]
     
Female     10     10     20  
Male     9     11     20  
Region of Enrollment  
[units: participants]
     
United States     19     21     40  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Brain Gray Matter Volume   [ Time Frame: 16 weeks compared to baseline ]

2.  Secondary:   Change in Pain Magnitude   [ Time Frame: 16 weeks compared to baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Apkar Vania Apkarian
Organization: Northwestern University
phone: (312) 503-0404
e-mail: a-apkarian@northwestern.edu



Responsible Party: Apkar Apkarian, Northwestern University
ClinicalTrials.gov Identifier: NCT01558700     History of Changes
Other Study ID Numbers: STU00039556
Study First Received: March 16, 2012
Results First Received: December 5, 2014
Last Updated: December 16, 2014
Health Authority: United States: Food and Drug Administration