A Trial of Wellbutrin for Crohn's Disease - Full Text View

Sponsor:	Altschuler, Eric, M.D.
Collaborator:	GlaxoSmithKline
Information provided by (Responsible Party):	Altschuler, Eric, M.D.
ClinicalTrials.gov Identifier:	NCT00126373

Purpose

The investigators are testing the hypothesis that Wellbutrin (bupropion) can give a clinical remission in Crohn's disease.

Condition	Intervention	Phase
Crohn Disease	Drug: Wellbutrin (bupropion)	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized Controlled Trial of Wellbutrin for Crohn's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Further study details as provided by Altschuler, Eric, M.D.:

Primary Outcome Measures:

Number of patients with Crohn's disease activity index (CDAI) < 150 at the end of twelve weeks [ Time Frame: 0, 2, 4, 8, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of patients with CDAI drop of at least 70 points at the end of twelve weeks [ Time Frame: 0, 12 weeks ] [ Designated as safety issue: No ]
Time course of CDAI [ Time Frame: 0, 2, 4, 8, 12 weeks ] [ Designated as safety issue: No ]
Effect of drug and/or placebo on tumor necrosis factor-alpha (TNF) levels [ Time Frame: 0, 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	1
Study Start Date:	May 2005
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Sugar pill Placebo (sugar) pill with identical look to bupropion	Drug: Wellbutrin (bupropion) bupropion 150mg-300mg daily Other Name: Wellbutrin, bupropion
Experimental: buproprion bupropion pill	Drug: Wellbutrin (bupropion) bupropion 150mg-300mg daily Other Name: Wellbutrin, bupropion

Detailed Description:

Wellbutrin (bupropion) is approved for use as an antidepressant. There have been some cases in which people on Wellbutrin had significant improvement clinically in their Crohn's disease. In this trial, the hypothesis that Wellbutrin can induce clinical remission in Crohn's disease will be tested. The investigators will also be looking to see if Wellbutrin can lower levels of the inflammatory cytokine tumor necrosis factor-alpha (TNF).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Moderate to severe Crohn's disease with 220 < CDAI < 400.
All patients in the study must have not had any anti-TNF antibodies for at least eight weeks.

Exclusion Criteria:

Patients will be excluded from the study if they have fulminant Crohn's disease requiring parenteral steroid treatment, hospitalization, or need of surgery imminently.
Patients with serious infections in the preceding three months, opportunistic infections within one month, or current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurological, or cerebral disease will be excluded.
Patients will also be excluded from the study if they have a history of a seizure, epilepsy, presumed current central nervous system tumor, have or have had anorexia nervosa or bulimia, are currently taking or have taken in the last four weeks any drug in the monoamine oxidase inhibitor class, or are allergic to Wellbutrin.
Patients with active major depression or suicidal ideation will be excluded, as will patients with a score of 19 or higher on the Beck depression inventory.
Patients will be excluded if they are currently or have taken a medicine in the selective serotonin reuptake class, mirtazapine, venlafaxine, a tricyclic antidepressant, a mood stabilizing, or antipsychotic medication in the previous two weeks.
Patients will be excluded if they are currently abusing alcohol or have alcohol dependence.
Patients will be excluded from the study if their baseline liver function tests are greater than twice the upper limit of normal, or if a clinical investigator believes that their baseline chemistry, liver function tests or complete blood count contraindicates entry into the study.
Pregnant or lactating females are excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126373

Locations

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, New York
Mt. Sinai Medical Center
New York, New York, United States, 10029

Sponsors and Collaborators

Altschuler, Eric, M.D.

GlaxoSmithKline

Investigators

Principal Investigator:

Eric L Altschuler, M.D., Ph.D.

Mt. Sinai Medical Center

More Information

No publications provided

Responsible Party:	Altschuler, Eric, M.D.
ClinicalTrials.gov Identifier:	NCT00126373 History of Changes
Other Study ID Numbers:	CGO10410022
Study First Received:	August 2, 2005
Last Updated:	January 19, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Altschuler, Eric, M.D.:

Crohn disease
TNF-alpha

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012