Oral Chronic Graft vs Host DiseasePhase 3NCT00887263
Efficacy and Safety Study of Budesonide to Treat Oral Chronic Graft vs Host Disease (cGvHD)
A Phase 3 study testing Budesonide in people with Oral Chronic Graft vs Host Disease, run by Dr. Falk Pharma GmbH at 2 sites in 2 countries.
Trial summary
The purpose of the study is to compare the efficacy and tolerability of budesonide 3 mg effervescent tablet (9 mg/day) compared to placebo for the treatment of patients with resistant oral cGvHD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oral Chronic Graft vs Host Disease
- What is being tested?
- Budesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2009to Oct 2015
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Karnofsky >= 70
- Oral chronic GvHD after allogeneic haematopoietic stem cell transplantation
- Oral cGvHD of erosive and/or ulcerative type
- NIH scale >= 3
- Resistant oral cGvHD with no oral response to conventional primary treatment
Who cannot join
- Uncertain diagnosis of resistant oral cGvHD
- Symptomatic oral cGvHD of hyperkeratotic type solely
- Current active oral bacterial, viral, or fungal infection
- Unwilling to forego concurrent treatment for mucosal lesions and/or related oral pain
- Requiring addition of new systemic therapy including steroids, or radiation therapy
- Local intestinal infection
Show all 9Show fewer
- Abnormal hepatic function or liver cirrhosis
- If careful medical monitoring is not ensured: tuberculosis, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, infection
- Second line treatment of oral cGvHD with topical steroids
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Israel1 site
The Hebrew University-Hadassah School of Dental Medicine, Department of Oral Medicine
Jerusalem, 91120
About this study
Official title: Double-blind, Randomised, Placebo-controlled Multicentre Phase III Clinical Study Followed by Open-label Phase on the Efficacy and Tolerability of Budesonide 3 mg Effervescent Tablet in Patients With Resistant Oral Chronic GvHD
The purpose of the study is to compare the efficacy and tolerability of budesonide 3 mg effervescent tablet (9 mg/day) compared to placebo for the treatment of patients with resistant oral cGvHD.
- Conditions
- Oral Chronic Graft vs Host Disease
- Being tested
- Budesonide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
3 mg TID
PlaceboDrug
0 mg TID
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Budesonide |
| B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with objective response
Measured: 12 weeks
Secondary outcomes (3)
Rate of complete/partial response, stable disease, progressive disease
Measured: 12 weeks
Time to initial objective response
Measured: x weeks
Rate of subjective improvement
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oral Chronic Graft vs Host 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon Elad, DMD, Principal investigator, University of Rochester Medical Center, Division of Oral Medicine, Eastman Institute for Oral Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887263
- Sponsor's protocol ID
- BUM-5/GVH
- Status last verified
- Jan 2016
- First submitted
- 22 Apr 2009
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Elad S, Or R, Garfunkel AA, Shapira MY. Budesonide: a novel treatment for oral chronic graft versus host disease. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Mar;95(3):308-11. doi: 10.1067/moe.2003.23.
PubMed 12627101Elad S, Zeevi I, Finke J, Koldehoff M, Schwerdtfeger R, Wolff D, Mohrbacher R, Levitt M, Greinwald R, Shapira MY. Improvement in oral chronic graft-versus-host disease with the administration of effervescent tablets of topical budesonide-an open, randomized, multicenter study. Biol Blood Marrow Transplant. 2012 Jan;18(1):134-40. doi: 10.1016/j.bbmt.2011.06.001. Epub 2011 Jun 12.
PubMed 21703973
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomised, Placebo-controlled Multicentre Phase III Clinical Study Followed by Open-label Phase on the Efficacy and Tolerability of Budesonide 3 mg Effervescent Tablet in Patients With Resistant Oral Chronic GvHD
- ClinicalTrials.gov ID
- NCT00887263
- Acronym / sponsor ID
- BUM-5/GVH
- Conditions
- Oral Chronic Graft vs Host Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 23 Apr 2009 (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 purpose of the study is to compare the efficacy and tolerability of budesonide 3 mg effervescent tablet (9 mg/day) compared to placebo for the treatment of patients with resistant oral cGvHD.
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 |
|---|---|---|
| A | Experimental | Drug: Budesonide |
| B | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Karnofsky >= 70
- Oral chronic GvHD after allogeneic haematopoietic stem cell transplantation
- Oral cGvHD of erosive and/or ulcerative type
- NIH scale >= 3
- Resistant oral cGvHD with no oral response to conventional primary treatment
Key exclusion criteria (9 listed)
- Uncertain diagnosis of resistant oral cGvHD
- Symptomatic oral cGvHD of hyperkeratotic type solely
- Current active oral bacterial, viral, or fungal infection
- Unwilling to forego concurrent treatment for mucosal lesions and/or related oral pain
- Requiring addition of new systemic therapy including steroids, or radiation therapy
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 |
|---|---|---|
| Budesonide3 mg TID | Drug | A |
| Placebo0 mg TID | Drug | B |
Primary outcome
Rate of patients with objective response
Time frame: 12 weeks
3 secondary outcomes
Rate of complete/partial response, stable disease, progressive disease
Time frame: 12 weeks
Time to initial objective response
Time frame: x weeks
Rate of subjective improvement
Time frame: 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 21 Jan 2016.
- Background: PubMed 12627101Elad S, Or R, Garfunkel AA, Shapira MY. Budesonide: a novel treatment for oral chronic graft versus host disease. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Mar;95(3):308-11. doi: 10.1067/moe.2003.23.
- Derived from this study: PubMed 21703973Elad S, Zeevi I, Finke J, Koldehoff M, Schwerdtfeger R, Wolff D, Mohrbacher R, Levitt M, Greinwald R, Shapira MY. Improvement in oral chronic graft-versus-host disease with the administration of effervescent tablets of topical budesonide-an open, randomized, multicenter study. Biol Blood Marrow Transplant. 2012 Jan;18(1):134-40. doi: 10.1016/j.bbmt.2011.06.001. Epub 2011 Jun 12.
Related trials for Oral Chronic Graft vs Host Disease
Active, not recruitingPhase 1/2
Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
Chronic Graft vs Host Disease, Chronic Graft-Versus-Host Disease
RecruitingPhase 2
A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant
Graft-Versus-Host Disease, GVHD
Active, not recruitingPhase 3
A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.
Chronic Graft Versus Host Disease
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
Not yet recruitingPhase 1
Study to Compare the Plasma Concentration of Belumosudil Given as an Oral Suspension and as a Tablet to Healthy Adult Male Participants
Chronic Graft Versus Host Disease
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.
Sharon Elad, DMD principal investigator
University of Rochester Medical Center, Division of Oral Medicine, Eastman Institute for Oral Health
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide in people with Oral Chronic Graft vs Host Disease, run by Dr. Falk Pharma GmbH at 2 sites in 2 countries.
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 5 inclusion and 9 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 21 Jan 2016. 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 Germany, Israel. 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 phase mean?
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?
Rate of patients with objective response (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00887263, which also lists 2 linked publications.
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 21 Jan 2016.