Crohn DiseasePhase 2/3NCT00126373
A Trial of Wellbutrin for Crohn's Disease
A Phase 2/3 study testing Wellbutrin (bupropion) in people with Crohn Disease, run by Altschuler, Eric, M.D. at 2 sites in United States.
Trial summary
The investigators are testing the hypothesis that Wellbutrin (bupropion) can give a clinical remission in Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Wellbutrin (bupropion)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2005to Mar 2006
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Chicago
Chicago, Illinois, 60637
Mt. Sinai Medical Center
New York, New York, 10029
About this study
Official title: A Randomized Controlled Trial of Wellbutrin for Crohn's Disease
The investigators are testing the hypothesis that Wellbutrin (bupropion) can give a clinical remission in Crohn's disease.
Read the 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).
- Conditions
- Crohn Disease
- Being tested
- Wellbutrin (bupropion)
- Keywords
- Crohn disease, TNF-alpha
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellbutrin (bupropion)Drug
Also called Wellbutrin, bupropion
bupropion 150mg-300mg daily
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | Placebo (sugar) pill with identical look to bupropion Receives: Drug: Wellbutrin (bupropion) |
| buproprion | Experimental | bupropion pill Receives: Drug: Wellbutrin (bupropion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Crohn's disease activity index (CDAI) < 150 at the end of twelve weeks
Measured: 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
Measured: 0, 12 weeks
Time course of CDAI
Measured: 0, 2, 4, 8, 12 weeks
Effect of drug and/or placebo on tumor necrosis factor-alpha (TNF) levels
Measured: 0, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2005 (estimated)
- Study startMay 2005
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altschuler, Eric, M.D.
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Eric L Altschuler, M.D., Ph.D., Principal investigator, Mt. Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126373
- Sponsor's protocol ID
- CGO10410022
- Status last verified
- Jan 2012
- First submitted
- 2 Aug 2005
- Last updated
- 20 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Wellbutrin for Crohn's Disease
- ClinicalTrials.gov ID
- NCT00126373
- Acronym / sponsor ID
- CGO10410022
- Conditions
- Crohn Disease
- Keywords
- Crohn disease, TNF-alpha
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Altschuler, Eric, M.D.
- Collaborators
- GlaxoSmithKline
- Study start
- May 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 4 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Drug: Wellbutrin (bupropion)Placebo (sugar) pill with identical look to bupropion |
| buproprion | Experimental | Drug: Wellbutrin (bupropion)bupropion pill |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellbutrin (bupropion)Also: Wellbutrin, bupropionbupropion 150mg-300mg daily | Drug | Sugar pill, buproprion |
Primary outcome
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
3 secondary outcomes
Number of patients with CDAI drop of at least 70 points at the end of twelve weeks
Time frame: 0, 12 weeks
Time course of CDAI
Time frame: 0, 2, 4, 8, 12 weeks
Effect of drug and/or placebo on tumor necrosis factor-alpha (TNF) levels
Time frame: 0, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric L Altschuler, M.D., Ph.D. principal investigator
Mt. Sinai Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Wellbutrin (bupropion) in people with Crohn Disease, run by Altschuler, Eric, M.D. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2012.