ColitisNCT00184171
Treatment of Microscopic Colitis
A study testing Budesonide, Bismuth and Fiber in people with Colitis, run by Norwegian University of Science and Technology at 9 sites in Norway.
Trial summary
The study compares the effect of Budesonide, Bismuth and fiber in patients with microscopic colitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis
- What is being tested?
- Budesonide, Bismuth and Fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 9 sitesNorway
- Study dates
- Nov 2001to Oct 2014
- Phase
- Interventional
- 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
- Microscopic colitis verified with biopsies from the colon
- Symptoms to such an extent that treatment is indicated
- Age > 17 years
- Informed consent
Who cannot join
- Previous treatment with any of the investigational drugs
- Patients treated with ketoconazole
- Pregnant and breast-feeding females
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Norway9 sites
Aust-Agder Sentralsjukehus
Arendal
Sykehuset Innlandet HF, Gjøvik
Gjøvik, 2819
Sykehuset Innlandet, HF, Hamar
Hamar
Sykehuset Innlandet HF, Lillehammer
Lillehammer
Helse NordMøre og Romsdal
Molde
Akershus Universitetssykehus
Nordbyhagen
Aker sykehus
Oslo
Rikshopitalet
Oslo
St. Olavs Hospital
Trondheim, 7006
About this study
Official title: Treatment of Microscopic Colitis (Collagenous Colitis and Lymphocytic Colitis) With Budesonide, Bismuth or Fiber
The study compares the effect of Budesonide, Bismuth and fiber in patients with microscopic colitis
Read the detailed description
This randomized, controlled, open study compares the effects of 8 weeks' treatment with Budesonide, Bismuth and fiber on symptoms and histological findings in patients with microscopic colitis (both collagenous colitis and lymphocytic colitis).
- Conditions
- Colitis
- Being tested
- Budesonide, Bismuth, Fiber
- Keywords
- Microscopic colitis, Drug treatment, Diarrhoea
- Medical subject headings
- Colitis, Colitis, Microscopic, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Budesonide 9 mg
BismuthDrug
Bismuth mixture
FiberDrug
Fiber for control
| Study group | Role | What they receive |
|---|---|---|
| Budesonide | Experimental | Budesonide 9mg Receives: Drug: Budesonide |
| bismuth | Experimental | Bismuth mixture Receives: Drug: Bismuth |
| Fiber | Sham comparator | Fiber preparation Receives: Drug: Fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms: Stool frequency and consistency
September 2010: Patient's enrollment completed. Data analysis ongoing.
Measured: 2001 - 2011
Secondary outcomes (1)
Histological findings in biopsies from colon
Patient's enrollment completed. Data analysis ongoing.
Measured: 2001 - 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2001
- Primary completionSep 2010
- Study completionOct 2014
Why it stopped: insufficient data quality
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColitisStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Per G Farup, PhD, Study chair, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184171
- Sponsor's protocol ID
- SLV 01-07035
- Status last verified
- Jan 2015
- First submitted
- 10 Sep 2005
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Microscopic Colitis (Collagenous Colitis and Lymphocytic Colitis) With Budesonide, Bismuth or Fiber
- ClinicalTrials.gov ID
- NCT00184171
- Acronym / sponsor ID
- SLV 01-07035
- Conditions
- Colitis
- Keywords
- Microscopic colitis, Drug treatment, Diarrhoea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient data quality
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Nov 2001
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 16 Sep 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 study compares the effect of Budesonide, Bismuth and fiber in patients with microscopic colitis
Detailed description
This randomized, controlled, open study compares the effects of 8 weeks' treatment with Budesonide, Bismuth and fiber on symptoms and histological findings in patients with microscopic colitis (both collagenous colitis and lymphocytic colitis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Budesonide | Experimental | Drug: BudesonideBudesonide 9mg |
| bismuth | Experimental | Drug: BismuthBismuth mixture |
| Fiber | Sham comparator | Drug: FiberFiber preparation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Microscopic colitis verified with biopsies from the colon
- Symptoms to such an extent that treatment is indicated
- Age > 17 years
- Informed consent
Key exclusion criteria (3 listed)
- Previous treatment with any of the investigational drugs
- Patients treated with ketoconazole
- Pregnant and breast-feeding females
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 |
|---|---|---|
| BudesonideBudesonide 9 mg | Drug | Budesonide |
| BismuthBismuth mixture | Drug | bismuth |
| FiberFiber for control | Drug | Fiber |
Primary outcome
Symptoms: Stool frequency and consistency
Time frame: 2001 - 2011
September 2010: Patient's enrollment completed. Data analysis ongoing.
1 secondary outcome
Histological findings in biopsies from colon
Time frame: 2001 - 2011
Results and safety
The study was stopped early (reason given: insufficient data quality). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
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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.
Per G Farup, PhD study chair
Norwegian University of Science and Technology
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Budesonide, Bismuth and Fiber in people with Colitis, run by Norwegian University of Science and Technology at 9 sites in Norway.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Norway. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: insufficient data quality). 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?
Symptoms: Stool frequency and consistency (time frame: 2001 - 2011). 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 21 Jan 2015.