Ulcerative ColitisPhase 1/2CUPE-1NCT01245465
Profermin® in Active Ulcerative Colitis
A Phase 1/2 study testing Profermin in people with Ulcerative Colitis, run by Nordisk Rebalance A/S.
Trial summary
In this study the investigators aim was to investigate the safety and possible efficacy of Profermin® in patients with ulcerative colitis. The investigators also aimed at assessing the usefulness of a new online daily symptom registration system. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Profermin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Nov 2009
- Phase
- Phase 1/2
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Patients who initiated treatment with azathioprine, 6-mercaptopurine, ciclosporin or methotrexate within 8 weeks prior to inclusion or TNF-α inhibitors within 12 weeks before inclusion or had changes in UC treatment within 2 weeks before inclusion were ineligible for the study. Concomitant coeliac disease or lactose intolerance were also exclusion criteria. In addition any malignant or premalignant condition or recent gastroenteritis rendered patients ineligible-
About this study
Official title: Safety and Efficacy of Profermin® to Induce Remission in Patients With Ulcerative Colitis
In this study the investigators aim was to investigate the safety and possible efficacy of Profermin® in patients with ulcerative colitis. The investigators also aimed at assessing the usefulness of a new online daily symptom registration system.
- Conditions
- Ulcerative Colitis
- Being tested
- Profermin
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProferminOther
Medical Food (food for special medical purposes)
| Study group | Role | What they receive |
|---|---|---|
| Profermin | Experimental | Daily oral intake of a food for special medical purposes (Profermin) Receives: Other: Profermin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Our primary endpoint was to estimate the proportion of patients with a reduction in SCCAI ≥50%.
Daily report of SCCAI symptoms on the Internet
Measured: 24 weeks
Secondary outcomes (1)
Our secondary endpoint was to estimate the proportion of patients in remission defined as SCCAI lower than or equal to 2.5
Daily report of SCCAI symptoms on the Internet
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2010 (estimated)
- Study startJan 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordisk Rebalance A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hvidovre University Hospital
- Investigators
- Hans Israelsen, PhD, Study director, Nordisk Rebalance A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245465
- Sponsor's protocol ID
- H-B-2008-FSP-20
- Acronym
- CUPE-1
- Status last verified
- Nov 2010
- First submitted
- 18 Nov 2010
- Last updated
- 23 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Profermin® to Induce Remission in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01245465
- Acronym / sponsor ID
- CUPE-1 / H-B-2008-FSP-20
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Nordisk Rebalance A/SIndustry (pharma, biotech, devices)
- Collaborators
- Hvidovre University Hospital
- Study start
- Jan 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 22 Nov 2010 (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.
In this study the investigators aim was to investigate the safety and possible efficacy of Profermin® in patients with ulcerative colitis. The investigators also aimed at assessing the usefulness of a new online daily symptom registration system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Profermin | Experimental | Other: ProferminDaily oral intake of a food for special medical purposes (Profermin) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients who initiated treatment with azathioprine, 6-mercaptopurine, ciclosporin or methotrexate within 8 weeks prior to inclusion or TNF-α inhibitors within 12 weeks before inclusion or had changes in UC treatment within 2 weeks before inclusion were ineligible for the study. Concomitant coeliac disease or lactose intolerance were also exclusion criteria. In addition any malignant or premalignant condition or recent gastroenteritis rendered patients ineligible-
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 |
|---|---|---|
| ProferminMedical Food (food for special medical purposes) | Other | Profermin |
Primary outcome
Our primary endpoint was to estimate the proportion of patients with a reduction in SCCAI ≥50%.
Time frame: 24 weeks
Daily report of SCCAI symptoms on the Internet
1 secondary outcome
Our secondary endpoint was to estimate the proportion of patients in remission defined as SCCAI lower than or equal to 2.5
Time frame: 24 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 23 Nov 2010.
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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.
Hans Israelsen, PhD study director
Nordisk Rebalance A/S
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Profermin in people with Ulcerative Colitis, run by Nordisk Rebalance A/S.
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 0 inclusion and 1 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 23 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Our primary endpoint was to estimate the proportion of patients with a reduction in SCCAI ≥50%. (time frame: 24 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 23 Nov 2010.