Ulcerative ColitisPhase 2/3CUPE2NCT01193894
Trial on Profermin and Fresubin in Ulcerative Colitis
A Phase 2/3 study testing Profermin and Fresubin in people with Ulcerative Colitis, run by Nordisk Rebalance A/S at 1 site in Denmark.
Trial summary
This study aim to investigate the effect of Profermin versus Fresubin in the dietetic treatment of active ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Profermin and Fresubin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2010to Dec 2012
- 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
- Active ulcerative colitis (SCCAI =>5 and <=11)
- Access to Internet
Who cannot join
- Stoma or intestinal resections
- Recent changes in UC medication
- Treatment with antibiotics
- Diabetes
- Celiac disease
- Lactose malabsorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial on Profermin and Fresubin for Dietetic Treatment of Active Ulcerative Colitis
This study aim to investigate the effect of Profermin versus Fresubin in the dietetic treatment of active ulcerative colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- Profermin, Fresubin
- Keywords
- IBD, UC, Profermin, Fresubin, Probiotics, Dietetic
- 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)
FresubinOther
Medical food (food for special medical purposes)
| Study group | Role | What they receive |
|---|---|---|
| Profermin | Experimental | Not described Receives: Other: Profermin |
| Fresubin | Active comparator | Not described Receives: Other: Fresubin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development in Simple Clinical Colitis Activity Index (SCCAI) score
Clinical significant difference (>1.5) in course of SCCAI score between the two intervention groups
Measured: 8 and 16 weeks
Secondary outcomes (3)
Reduction in SCCAI score
Proportion of patients with a reduction in SCCAI above 1.5, 3.0 and 4.5
Measured: 8 and 16 weeks
Clinical remission
Proportion of patients in clinical remission (SCCAI=<2.5)
Measured: 8 and 16 weeks
Safety - Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2012
- Study completionDec 2012
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordisk Rebalance A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Sponsor
- Investigators
- Hans Israelsen, PhD, Study director, Nordisk Rebalance A/SAleksander Krag, MD, PhD, Principal investigator, Hvidovre University HospitalFlemming Bendtsen, MD, DMSci, Study chair, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193894
- Sponsor's protocol ID
- CUPE2
- Acronym
- CUPE2
- Status last verified
- Dec 2013
- First submitted
- 23 Aug 2010
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial on Profermin and Fresubin for Dietetic Treatment of Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01193894
- Acronym / sponsor ID
- CUPE2 / CUPE2
- Conditions
- Ulcerative Colitis
- Keywords
- IBD, UC, Profermin, Fresubin, Probiotics, Dietetic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Nordisk Rebalance A/SIndustry (pharma, biotech, devices)
- Collaborators
- Hvidovre University Hospital
- Study start
- Aug 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Sep 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.
This study aim to investigate the effect of Profermin versus Fresubin in the dietetic treatment of active ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Profermin | Experimental | Other: Profermin |
| Fresubin | Active comparator | Other: Fresubin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Active ulcerative colitis (SCCAI =>5 and <=11)
- Access to Internet
Key exclusion criteria (6 listed)
- Stoma or intestinal resections
- Recent changes in UC medication
- Treatment with antibiotics
- Diabetes
- Celiac disease
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 |
| FresubinMedical food (food for special medical purposes) | Other | Fresubin |
Primary outcome
Development in Simple Clinical Colitis Activity Index (SCCAI) score
Time frame: 8 and 16 weeks
Clinical significant difference (>1.5) in course of SCCAI score between the two intervention groups
3 secondary outcomes
Reduction in SCCAI score
Time frame: 8 and 16 weeks
Clinical remission
Time frame: 8 and 16 weeks
Safety - Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 20 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 17 Dec 2013.
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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
Aleksander Krag, MD, PhD principal investigator
Hvidovre University Hospital
Flemming Bendtsen, MD, DMSci study chair
Hvidovre University Hospital
1 site 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 Profermin and Fresubin in people with Ulcerative Colitis, run by Nordisk Rebalance A/S at 1 site in Denmark.
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 6 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 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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. 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?
Development in Simple Clinical Colitis Activity Index (SCCAI) score (time frame: 8 and 16 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 17 Dec 2013.