Paroxetine - Controlled Release in the Treatment of Irritable Bowel Syndrome (IBS)

PHASE4CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 31, 2002

Primary Completion Date

December 31, 2002

Study Completion Date

December 31, 2002

Conditions
Irritable Bowel Syndrome
Interventions
DRUG

Paroxetine CR

Those in the active treatment group will receive doses of Paxil CR in increments of 12.5 mg daily for the first week and increased at 12.5 mg increments at visit weeks to a maximum of 50 mg daily, as determined by the investigator. The investigator will adjust dosage based on clinical response. Following the completion of the double-blind phase, patients on placebo and non-responders to the study drug will be tapered off the study drug back to 0 over 2 weeks, and they will be referred to their Primary Care Physician, Internist or Gastroenterologist to be prescribed treatment for Irritable Bowel Syndrome.

DRUG

Placebo

Placebo

Trial Locations (1)

27705

Department of Psychiatry Clinical Trial Team, Duke University, Durham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Duke University

OTHER

NCT00610909 - Paroxetine - Controlled Release in the Treatment of Irritable Bowel Syndrome (IBS) | Biotech Hunter | Biotech Hunter