Imipramine and Pregabalin Combination in Painful Polyneuropathy

PHASE4UnknownINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

February 28, 2010

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Polyneuropathy
Interventions
DRUG

Imipramine

Tablet 25 mg, 3 tablets evening (extensive metabolizers) or 1 tablet evening (poor metabolizers), daily, 5 weeks

DRUG

Pregabalin

Capsule 75 mg, 2 capsules twice daily, daily, 5 weeks

DRUG

Imipramine, pregabalin

Imipramine: tablet 25 mg, 3 tablets evening (extensive metabolizers) or 1 tablet evening (poor metabolizers), daily, 5 weeks Pregabalin: capsule 75 mg, 2 capsules twice daily, daily, 5 weeks

DRUG

Placebo

Placebo tablets to imipramine 25 mg, 3 or 1 tablet evening, daily, 5 weeks Placebo capsules to pregabalin 75 mg, 2 capsules daily, daily, 5 weeks

Trial Locations (3)

DK-9000

Department of Neurology, Aalborg Hospital, Aalborg

DK-8000

Department of Neurology, Aarhus University Hospital, Aarhus

DK-5000

Department of Neurology, Odense University Hospital, Odense

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

Nycomed

INDUSTRY

lead

Odense University Hospital

OTHER