Clinical Trial: "MILNACIPRAN" in Subjects With Chronic Shoulder Pain

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Exploratory, Randomized, Single Blinded, Placebo-Controlled, Dose-Ranging Study of the Safety and Efficacy of "MILNACIPRAN" in Subjects With Chronic Shoulder Pain

Brief Summary: The purpose of this study is to compare the safety and efficacy of multiple doses of "Milnacipran" to a placebo dose in subjects with Chronic Shoulder Pain.

Detailed Summary: 16 weeks. It is planned that this study will be conducted at a single site and will enroll approximately 40 subjects over 2-4 months. At the end of the 12-week dosing period, the study drug will be discontinued and all subjects in the treatment groups and control group will be followed for an additional 4 weeks.
Sponsor: Valera Bussell

Current Primary Outcome: The primary efficacy endpoint will be the reduction in the mean VAS for chronic shoulder pain [ Time Frame: Week 12 ]

The primary efficacy endpoint will be the reduction in the mean VAS (Visual Analog Scale) for chronic shoulder pain at Week 12


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Improvement in the PGIC [ Time Frame: Week 12 ]
    Overall improvement in the PGIC (Patient Global Impression of Change) at Week 12
  • An improvement in the SPADI score [ Time Frame: Week 12 ]
    Improvement in the SPADI (Shoulder Pain and Disability Index) score at Week 12
  • Improvement in the SF-36 Health Questionnaire [ Time Frame: Week 12 ]
    Improvement in the SF-36 (Short Form-36) Health Questionnaire at Week 12


Original Secondary Outcome: Same as current

Information By: Delray Research Associates

Dates:
Date Received: February 1, 2011
Date Started: October 2009
Date Completion:
Last Updated: August 7, 2012
Last Verified: August 2012