Ulcerative ColitisPhase 2/3NCT00259571
Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.
A Phase 2/3 study testing retarded release phosphatidylcholine in people with Ulcerative Colitis, run by Heidelberg University at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate if retarded phosphatidylcholine is as effective as mesalazin in preventing an acute episode in ulcerative colitis. The hypothesis is, that ulcerative colitis is cuased by a defect in the barrier function of the colonic mucus. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- retarded release phosphatidylcholine
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento Mar 2010
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosis of ulcerative colitis in remission (CAI 3 or less)
- signed letter of content
- no steroids or immunosupressants in the last 6 weeks
- at least 5 relapses in the last 3 years
- last relapse was 8 months ago or less
- complete colonoscopy at entry
Who cannot join
- pregnancy or breast feeding
- steroids or immunosuppressants
- acute episode of UC
- condition after complete or partial colektomy
- known intolerance to mesalazin
- severe medical disease other than colitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospektive, Randomisierte, Doppelblinde, Mesalazin-kontrollierte ("Double-dummy Verfahren) Multizenter-Studie Zur Beurteilung Der Annahme Der äquivalenten Wirkung Von Intestinal Retardiert Freigesetztem Phosphatidylcholin gegenüber Mesalazin (Non-inferiority Study) in Der Remissionserhaltung Der Colitis Ulcerosa.
The purpose of this study is to evaluate if retarded phosphatidylcholine is as effective as mesalazin in preventing an acute episode in ulcerative colitis.
The hypothesis is, that ulcerative colitis is cuased by a defect in the barrier function of the colonic mucus. The background of the study is the finding that the phosphatidylcholine content of the colonic mucus is reduced in patients with ulcerative colitis, in both healthy and inflamed parts of the colon.
- Conditions
- Ulcerative Colitis
- Being tested
- retarded release phosphatidylcholine
- Keywords
- remission, mesalazin, non-inferiority study, relapse
- Medical subject headings
- Colitis, Ulcerative, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retarded release phosphatidylcholineDrug
2g daily, given orally QTD
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of relapses
relapse is defined as an increase of the clinical Rachmilewitz index to 5 or more, but at least 3 points over a period of 14 days
Secondary outcomes (6)
time to the first relapse
amount of relapses per year
endoscopic index
histolgical score
life quality
side effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study completionMar 2010
Why it stopped: Missing financial sponsorship
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Dietmar Hopp Stiftung
- Investigators
- Wolfgang Stremmel, Professor, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259571
- Sponsor's protocol ID
- PC4
- Other IDs
- EC - L389/2003, BFARM - 402 2918
- Status last verified
- Nov 2005
- First submitted
- 28 Nov 2005
- Last updated
- 13 Dec 2013
- Results posted
- No
Publications
Stremmel W, Merle U, Zahn A, Autschbach F, Hinz U, Ehehalt R. Retarded release phosphatidylcholine benefits patients with chronic active ulcerative colitis. Gut. 2005 Jul;54(7):966-71. doi: 10.1136/gut.2004.052316.
PubMed 15951544
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospektive, Randomisierte, Doppelblinde, Mesalazin-kontrollierte ("Double-dummy Verfahren) Multizenter-Studie Zur Beurteilung Der Annahme Der äquivalenten Wirkung Von Intestinal Retardiert Freigesetztem Phosphatidylcholin gegenüber Mesalazin (Non-inferiority Study) in Der Remissionserhaltung Der Colitis Ulcerosa.
- ClinicalTrials.gov ID
- NCT00259571
- Acronym / sponsor ID
- PC4
- Conditions
- Ulcerative Colitis
- Keywords
- remission, mesalazin, non-inferiority study, relapse
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Missing financial sponsorship
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Dietmar Hopp Stiftung
- Study completion
- Mar 2010
- First posted
- 29 Nov 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 purpose of this study is to evaluate if retarded phosphatidylcholine is as effective as mesalazin in preventing an acute episode in ulcerative colitis.
The hypothesis is, that ulcerative colitis is cuased by a defect in the barrier function of the colonic mucus. The background of the study is the finding that the phosphatidylcholine content of the colonic mucus is reduced in patients with ulcerative colitis, in both healthy and inflamed parts of the colon.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of ulcerative colitis in remission (CAI 3 or less)
- signed letter of content
- no steroids or immunosupressants in the last 6 weeks
- at least 5 relapses in the last 3 years
- last relapse was 8 months ago or less
Key exclusion criteria (6 listed)
- pregnancy or breast feeding
- steroids or immunosuppressants
- acute episode of UC
- condition after complete or partial colektomy
- known intolerance to mesalazin
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 |
|---|---|---|
| retarded release phosphatidylcholine2g daily, given orally QTD | Drug | – |
Primary outcome
rate of relapses
relapse is defined as an increase of the clinical Rachmilewitz index to 5 or more, but at least 3 points over a period of 14 days
6 secondary outcomes
time to the first relapse
amount of relapses per year
endoscopic index
histolgical score
life quality
side effects
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
- Background: PubMed 15951544Stremmel W, Merle U, Zahn A, Autschbach F, Hinz U, Ehehalt R. Retarded release phosphatidylcholine benefits patients with chronic active ulcerative colitis. Gut. 2005 Jul;54(7):966-71. doi: 10.1136/gut.2004.052316.
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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.
Wolfgang Stremmel, Professor principal investigator
Heidelberg University
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 retarded release phosphatidylcholine in people with Ulcerative Colitis, run by Heidelberg University at 1 site in Germany.
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 6 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: withdrawn, as of the sponsor's last update on 13 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 Germany. 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 was withdrawn before enrolling participants, so there are no results.
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 relapses. The study lists 2 primary outcomes in all. 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 NCT00259571, which also lists 1 linked publication.
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 13 Dec 2013.