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A Trial of Wellbutrin for Crohn's Disease

Primary Purpose

Crohn Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Wellbutrin (bupropion)
Sponsored by
Altschuler, Eric, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring Crohn disease, TNF-alpha

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Chicago
  • Mt. Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Sugar pill

buproprion

Arm Description

Placebo (sugar) pill with identical look to bupropion

bupropion pill

Outcomes

Primary Outcome Measures

Number of patients with Crohn's disease activity index (CDAI) < 150 at the end of twelve weeks

Secondary Outcome Measures

Number of patients with CDAI drop of at least 70 points at the end of twelve weeks
Time course of CDAI
Effect of drug and/or placebo on tumor necrosis factor-alpha (TNF) levels

Full Information

First Posted
August 2, 2005
Last Updated
January 19, 2012
Sponsor
Altschuler, Eric, M.D.
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00126373
Brief Title
A Trial of Wellbutrin for Crohn's Disease
Official Title
A Randomized Controlled Trial of Wellbutrin for Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Altschuler, Eric, M.D.
Collaborators
GlaxoSmithKline

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Crohn disease, TNF-alpha

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Placebo (sugar) pill with identical look to bupropion
Arm Title
buproprion
Arm Type
Experimental
Arm Description
bupropion pill
Intervention Type
Drug
Intervention Name(s)
Wellbutrin (bupropion)
Other Intervention Name(s)
Wellbutrin, bupropion
Intervention Description
bupropion 150mg-300mg daily
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Number of patients with CDAI drop of at least 70 points at the end of twelve weeks
Time Frame
0, 12 weeks
Title
Time course of CDAI
Time Frame
0, 2, 4, 8, 12 weeks
Title
Effect of drug and/or placebo on tumor necrosis factor-alpha (TNF) levels
Time Frame
0, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric L Altschuler, M.D., Ph.D.
Organizational Affiliation
Mt. Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Mt. Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Trial of Wellbutrin for Crohn's Disease

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