NCT00126373

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

January 20, 2012

Status Verified

January 1, 2012

Enrollment Period

10 months

First QC Date

August 2, 2005

Last Update Submit

January 19, 2012

Conditions

Crohn Disease

Keywords

Crohn diseaseTNF-alpha

Outcome Measures

Primary Outcomes (1)

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

    0, 2, 4, 8, 12 weeks

Secondary Outcomes (3)

  • Number of patients with CDAI drop of at least 70 points at the end of twelve weeks

    0, 12 weeks

  • Time course of CDAI

    0, 2, 4, 8, 12 weeks

  • Effect of drug and/or placebo on tumor necrosis factor-alpha (TNF) levels

    0, 12 weeks

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR

Placebo (sugar) pill with identical look to bupropion

Drug: Wellbutrin (bupropion)

buproprion

EXPERIMENTAL

bupropion pill

Drug: Wellbutrin (bupropion)

Interventions

Wellbutrin (bupropion)DRUG

bupropion 150mg-300mg daily

Also known as: Wellbutrin, bupropion
Sugar pillbuproprion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Mt. Sinai Medical Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • Eric L Altschuler, M.D., Ph.D.

    Mt. Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2005

First Posted

August 4, 2005

Study Start

May 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

January 20, 2012

Record last verified: 2012-01

Locations

US(2)