Collagenous ColitisPhase 3NCT00139165
Long-Term Treatment of Collagenous Colitis With Budesonide
A Phase 3 study testing Budesonide and sigmoidoscopy in people with Collagenous Colitis, run by Bonderup, Ole K., M.D. at 2 sites in Denmark.
Trial summary
The aim of the trial is to examine the effect of budesonide treatment on collagenous colitis. All patients is treated for 6 weeks with budesonide and thereafter randomised to 24 weeks treatment with placebo or continued budesonide. The end poit is effect on clinical symptoms (number of daily stools) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Collagenous Colitis
- What is being tested?
- Budesonide and sigmoidoscopy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 36 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2004to Mar 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological criteria of Collagenous colitis
- Clinical activity (> 3 stools/day)
Who cannot join
- Treatment of Collagenous colitis within the last 3 months
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Dept. of medical gastroenterology
Aalborg, 9100
Dept. of medical gastroenterology
Aarhus, 8000
About this study
Official title: Long-Term Treatment of Collagenous Colitis With Budesonide. Prospective, Doubleblind Placebo-Controlled Trial.
The aim of the trial is to examine the effect of budesonide treatment on collagenous colitis. All patients is treated for 6 weeks with budesonide and thereafter randomised to 24 weeks treatment with placebo or continued budesonide. The end poit is effect on clinical symptoms (number of daily stools)
- Conditions
- Collagenous Colitis
- Being tested
- Budesonide, sigmoidoscopy
- Keywords
- Collagenous colitis, Budesonide treatment, Diarrhea
- Medical subject headings
- Colitis, Collagenous, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Capsule. Oral 6 mg o.d. for 24 weeks
sigmoidoscopyProcedure or surgery
Sigmoidoscopy performed 2 times during the study period.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical symptoms
Secondary outcomes (1)
Histological changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startSep 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Collagenous 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Bonderup, Ole K., M.D.
- Collaborators
- AstraZeneca
- Investigators
- Ole K Bonderup, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139165
- Sponsor's protocol ID
- okbon123
- Status last verified
- Aug 2005
- First submitted
- 29 Aug 2005
- Last updated
- 6 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Treatment of Collagenous Colitis With Budesonide. Prospective, Doubleblind Placebo-Controlled Trial.
- ClinicalTrials.gov ID
- NCT00139165
- Acronym / sponsor ID
- okbon123
- Conditions
- Collagenous Colitis
- Keywords
- Collagenous colitis, Budesonide treatment, Diarrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants
- Lead sponsor
- Bonderup, Ole K., M.D.
- Collaborators
- AstraZeneca
- Study start
- Sep 2004
- Study completion
- Mar 2006
- First posted
- 31 Aug 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 aim of the trial is to examine the effect of budesonide treatment on collagenous colitis. All patients is treated for 6 weeks with budesonide and thereafter randomised to 24 weeks treatment with placebo or continued budesonide. The end poit is effect on clinical symptoms (number of daily stools)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histological criteria of Collagenous colitis
- Clinical activity (> 3 stools/day)
Key exclusion criteria (1 listed)
- Treatment of Collagenous colitis within the last 3 months
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 |
|---|---|---|
| BudesonideCapsule. Oral 6 mg o.d. for 24 weeks | Drug | – |
| sigmoidoscopySigmoidoscopy performed 2 times during the study period. | Procedure or surgery | – |
Primary outcome
Clinical symptoms
1 secondary outcome
Histological changes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2008.
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.
Ole K Bonderup, MD principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide and sigmoidoscopy in people with Collagenous Colitis, run by Bonderup, Ole K., M.D. at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 6 Mar 2008. 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 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 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?
Results are not available in the source record.
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?
Clinical symptoms. 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 6 Mar 2008.