Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)

PHASE3CompletedINTERVENTIONAL
Enrollment

271

Participants

Timeline

Start Date

February 28, 2005

Primary Completion Date

April 30, 2008

Study Completion Date

December 31, 2008

Conditions
Bladder DiseasesInterstitial Cystitis
Interventions
DRUG

Amitriptyline

Amitriptyline will be titrated over a 6-week period as tolerated, to a maximum dose of 75mg. During the 6-week titration period, the patient who cannot tolerate a scheduled increased dose may adjust the medication dose for tolerance by tapering down one 25mg tablet.

OTHER

Placebo

Placebo will be dosed exactly as active arm.

Trial Locations (10)

14642

University of Rochester Medical Center, Rochester

19104

University of Pennsylvania, Philadelphia

21201

University of Maryland, Baltimore

48073

William Beaumont Hospital, Royal Oak

48202

Henry Ford Hospital, Detroit

52242

University of Iowa Hospitals and Clinic, Iowa City

60153

Loyola University Medical Center, Maywood

94305

Stanford University Medical Center, Stanford

98195

University of Washington, Seattle

K7L 2Y7

Queen's University, Kingston

All Listed Sponsors
collaborator

University of Pennsylvania

OTHER

lead

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

NCT00124306 - Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS) | Biotech Hunter | Biotech Hunter