NCT00844194 - Duloxetine in Patients With Diabetic in Peripheral Neuropathic Pain With or Without Co-morbid Major Depressive Disorder | Biotech Hunter

Enrollment

108

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

June 30, 2010

Conditions

Diabetic NeuropathiesDepressive Disorder, Major

Interventions

DRUG

Duloxetine 60 mg QD

given to (1) all patients week 2-6; (2) all responders of both arms week 7-12

DRUG

Duloxetine 60 mg QD

given to (1) all patients week 2-6; (2) all responders of both arms week 7-12

DRUG

Duloxetine 30 mg QD

given to (1) all patients for one week as taper in; (2) all patients for taper down (responder for 2 weeks)

DRUG

Duloxetine 30 mg QD

given to (1) all patients for one week as taper in; (2) all patients for taper down (responder for 2 weeks)

DRUG

Duloxetine 90 mg QD

given to non-responders of both arms from day of notice that 120 mg is not tolerated to week 12 as 60 mg+30 mg Duloxetine QD

DRUG

Duloxetine 90 mg QD

given to non-responders of both arms from day of notice that 120 mg is not tolerated to week 12 as 60 mg+30 mg Duloxetine QD

DRUG

Duloxetine 60 mg QD

given to (1) all patients week 2-6; (2) all non-responders of both arms for first week of taper down

DRUG

Duloxetine 60 mg QD

given to (1) all patients week 2-6; (2) all non-responders of both arms for first week of taper down

DRUG

Duloxetine 120 mg QD

given to non-responders of both arms from week 7-12 as 2x60 mg Duloxetine QD, if tolerated

DRUG

Duloxetine 30 mg QD

given to (1) all patients for one week as taper in; (2) all patients for taper down (non-responder for the second week of taper down)

DRUG

Duloxetine 30 mg QD

given to (1) all patients for one week as taper in; (2) all patients for taper down (non-responder for the second week of taper down)

DRUG

Duloxetine 120 mg QD

given to non-responders of both arms from week 7-12 as 2x60 mg Duloxetine QD, if tolerated

Trial Locations (25)

Unknown

1208.34.49008 Boehringer Ingelheim Investigational Site, Achim Bei Bremen

1208.34.49025 Boehringer Ingelheim Investigational Site, Aschaffenburg

1208.34.49001 Boehringer Ingelheim Investigational Site, Bad Mergentheim

1208.34.49018 Boehringer Ingelheim Investigational Site, Baesweiler

1208.34.49002 Boehringer Ingelheim Investigational Site, Berlin

1208.34.49005 Boehringer Ingelheim Investigational Site, Berlin

1208.34.49009 Boehringer Ingelheim Investigational Site, Berlin

1208.34.49021 Boehringer Ingelheim Investigational Site, Bremen

1208.34.49028 Boehringer Ingelheim Investigational Site, Frankfurt am Main

1208.34.49012 Boehringer Ingelheim Investigational Site, Gera

1208.34.49004 Boehringer Ingelheim Investigational Site, Hamburg

1208.34.49020 Boehringer Ingelheim Investigational Site, Hamburg

1208.34.49023 Boehringer Ingelheim Investigational Site, Hamburg

1208.34.49015 Boehringer Ingelheim Investigational Site, Hattingen

1208.34.49027 Boehringer Ingelheim Investigational Site, Heidenheim

1208.34.49016 Boehringer Ingelheim Investigational Site, Kelkheim

1208.34.49006 Boehringer Ingelheim Investigational Site, Limburgerhof

1208.34.49022 Boehringer Ingelheim Investigational Site, Münster

1208.34.49019 Boehringer Ingelheim Investigational Site, Neuwied

1208.34.49024 Boehringer Ingelheim Investigational Site, Saint Ingberg

1208.34.49007 Boehringer Ingelheim Investigational Site, Steglitz

1208.34.49010 Boehringer Ingelheim Investigational Site, Stuhr

1208.34.49013 Boehringer Ingelheim Investigational Site, Unterhaching

1208.34.49029 Boehringer Ingelheim Investigational Site, Wiesbaden

1208.34.49026 Boehringer Ingelheim Investigational Site, Wuppertal