Ulcerative ColitisNCT00463619
Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Heidelberg University at 1 site in Germany.
Trial summary
Follow-Up Study with Retarded Release Phosphatidylcholine in Ulcerative Colitis Objectives: The objective of the study is to evaluate the follow up of patients treated with retarded release phosphatidylcholine in three controlled, randomized studies. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Retarded release phosphatidylcholine
- How many people
- 132 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2000to Apr 2010
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from previous studies with retarded release phosphatidylcholine
Who may be able to join
- Patients from previous studies with retarded release phosphatidylcholine
Who cannot join
- patients with less then 6 weeks follow-up after end of initial study
Trial locations and contacts
1 site in 1 country.
About this study
Follow-Up Study with Retarded Release Phosphatidylcholine in Ulcerative Colitis
Objectives:
Read more
The objective of the study is to evaluate the follow up of patients treated with retarded release phosphatidylcholine in three controlled, randomized studies.
Main question is to investigate whether treatment with phosphatidylcholine could spare patients the intake of steroids and immunosuppressants without clinical deterioration.
Study population:
- Retarded release phosphatidylcholine in chronic-active ulcerative colitis.
- Retarded release phosphatidylcholine in steroid dependent ulcerative colitis.
- Dose finding study for retarded release phosphatidylcholine
Outcome parameters:
Definition of remission:
- SCCAI <2,5
- Likert scale: grade 1 or 2
- subjective impression of remission: yes/no
- no blood in stool
Definition of relapse:
- subjective impression: yes/no
- SCCAI ≥ 5
- blood in stool
Definition of low clinical activity: SCCAI < 5
Primary endpoint:
sparing effect of steroids and/or immunosuppressants by rPC in chronic active UC.
Secondary endpoints
- maintenance of continuous remission
- improvement of disease activity: a. clinical activity (SCCAI) b.life quality (SIBDQ-D) c.Likert Score
- relapse rate: a. time to first relapse b. clinical activity during relapses c. number of relapses in relation to length of treatment
- Conditions
- Ulcerative Colitis
- Being tested
- Retarded release phosphatidylcholine
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retarded release phosphatidylcholineDrug
2g phosphatidylcholine, given QTD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startApr 2000
- Primary completionApr 2010
- Study completionApr 2010
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Max Karner, MD, Study chair, University Heidelberg - GastroenterologyVerena Schmieg, Cand. med., Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463619
- Sponsor's protocol ID
- AVT123
- Status last verified
- Apr 2010
- First submitted
- 18 Apr 2007
- Last updated
- 16 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00463619
- Acronym / sponsor ID
- AVT123
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Apr 2000
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 20 Apr 2007 (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.
Follow-Up Study with Retarded Release Phosphatidylcholine in Ulcerative Colitis
Objectives:
The objective of the study is to evaluate the follow up of patients treated with retarded release phosphatidylcholine in three controlled, randomized studies.
Main question is to investigate whether treatment with phosphatidylcholine could spare patients the intake of steroids and immunosuppressants without clinical deterioration.
Study population:
- Retarded release phosphatidylcholine in chronic-active ulcerative colitis.
- Retarded release phosphatidylcholine in steroid dependent ulcerative colitis.
- Dose finding study for retarded release phosphatidylcholine
Outcome parameters:
Definition of remission:
- SCCAI <2,5
- Likert scale: grade 1 or 2
- subjective impression of remission: yes/no
- no blood in stool
Definition of relapse:
- subjective impression: yes/no
- SCCAI ≥ 5
- blood in stool
Definition of low clinical activity: SCCAI < 5
Primary endpoint:
sparing effect of steroids and/or immunosuppressants by rPC in chronic active UC.
Secondary endpoints
- maintenance of continuous remission
- improvement of disease activity: a. clinical activity (SCCAI) b.life quality (SIBDQ-D) c.Likert Score
- relapse rate: a. time to first relapse b. clinical activity during relapses c. number of relapses in relation to length of treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from previous studies with retarded release phosphatidylcholine
Key inclusion criteria (1 listed)
- Patients from previous studies with retarded release phosphatidylcholine
Key exclusion criteria (1 listed)
- patients with less then 6 weeks follow-up after end of initial study
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 phosphatidylcholine, given QTD | Drug | – |
Primary outcome
Not reported in the source record.
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 16 Aug 2011.
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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.
Max Karner, MD study chair
University Heidelberg - Gastroenterology
Verena Schmieg, Cand. med. 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?
An observational study of 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 1 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 16 Aug 2011. 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.
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.
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 16 Aug 2011.