Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia

PHASE4CompletedINTERVENTIONAL
Enrollment

107

Participants

Timeline

Start Date

February 28, 2010

Primary Completion Date

December 31, 2010

Study Completion Date

January 31, 2011

Conditions
Fibromyalgia
Interventions
DRUG

Placebo

"* Placebo tablets, oral administration, twice daily for 10 weeks during randomized, double-blind treatment period. Duloxetine capsules, oral administration, 30 mg/day for 1 week after randomization to effect a duloxetine down-taper.~* Placebo tablets, twice daily for 1 week during double-blind down-taper treatment period."

DRUG

Milnacipran

"* Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses for 10 weeks during randomized, double-blind treatment period. Placebo capsules, 1 capsule/day administered for 1 week after randomization to maintain double-blind duloxetine down-taper.~* Milnacipran tablets, 100 to 0 mg/day, oral administration, twice daily in divided doses for 1 week during double-blind down-taper treatment period."

Trial Locations (26)

13210

Forest Investigative Site 014, Syracuse

17055

Forest Investigative Site 020, Mechanicsburg

28209

Forest Investigative Site 023, Charlotte

29651

Forest Investigative Site 011, Greer

30328

Forest Investigative Site 006, Atlanta

Forest Investigative Site 024, Atlanta

32806

Forest Investigative Site 009, Orlando

Forest Investigative Site 016, Orlando

33484

Forest Investigative Site 007, Delray Beach

33614

Forest Investigative Site 019, Tampa

33709

Forest Investigative Site 012, St. Petersburg

34471

Forest Investigative Site 008, Ocala

39202

Forest Investigative Site 010, Jackson

44122

Forest Investigative Site 003, Cleveland

45219

Forest Investigative Site 002, Cincinnati

47713

Forest Investigative Site 015, Evansville

53406

Forest Investigative Site 026, Racine

63141

Forest Investigative Site 025, St Louis

84102

Forest Investigative Site 004, Salt Lake City

95825

Forest Investigative Site 013, Sacramento

97504

Forest Investigative Site 001, Medford

98007

Forest Investigative Site 017, Bellevue

06416

Forest Investigative Site 022, Cromwell

06810

Forest Investigative Site 021, Danbury

01610

Forest Investigative Site 005, Worchester

08046

Forest Investigative Site 018, Willingboro

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cypress Bioscience, Inc.

INDUSTRY

lead

Forest Laboratories

INDUSTRY

NCT01077375 - Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia | Biotech Hunter | Biotech Hunter