NCT01289236

"MILNACIPRAN" in Subjects With Chronic Shoulder Pain

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Valera Bussell · Industry
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Chronic Shoulder Pain

Interventions

Type	Name	Description
DRUG	milnacipran	1 tablet (50mg) BID (twice daily, approximately 12 hours apart) for 12 weeks after appropriate titration period
DRUG	Milnacipran	1 tablet (100mg) BID (twice daily, approximately 12 hours apart)for 12 weeks after appropriate titration period.
DRUG	Placebo	1 tablet (placebo) BID (twice daily, approximately 12 hours apart) for 12 weeks after appropriate titration period.

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-02-03
• Last updated: 2012-08-09

Locations

1 site across 1 country: United States