Colitis, UlcerativePhase 2TOPICAL-1NCT02550418
Budesonide 9 mg Capsules in Active UC
A Phase 2 study testing Budesonide in people with Colitis, Ulcerative, run by Dr. Falk Pharma GmbH at 1 site in Germany.
Trial summary
The purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Mar 2017
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent,
- Men or women aged 18 to 75 years,
- Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology,
- Established disease,
Who cannot join
- Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete microscopic colitis), diverticular disease associated colitis,
- Toxic megacolon or fulminant colitis,
- Colon resection,
- Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening),
- Malabsorption syndromes,
- Celiac disease,
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- Bleeding hemorrhoids,
- Active peptic ulcer disease
- Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding,
- Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured,
- Any severe infectious disease (e.g., tuberculosis, AIDS),
- Severe co-morbidity substantially reducing life expectancy,
- History of colorectal cancer,
- History of cancer (other than colorectal) in the last 5 years, except for basal cell carcinoma
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
About this study
Official title: Open-label, Multi-centre, Proof of Concept Phase IIa Clinical Trial on the Efficacy and Tolerability of an 8 Week Oral Treatment With Once Daily 9 mg Budesonide in Patients With Active Ulcerative Colitis
The purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis
- Conditions
- Colitis, Ulcerative
- Being tested
- Budesonide
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
| Study group | Role | What they receive |
|---|---|---|
| Budesonide | Experimental | Not described Receives: Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical remission at final/withdrawal visit
Clinical remission includes normalisation of stool frequency and absence of blood in stools
Measured: 8 weeks treatment
Secondary outcomes (2)
Rate of endoscopic remission/improvement at final/withdrawal visit
Measured: 8 weeks treatment
Number of stools / bloody stools per week
Measured: 8 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2017
- Study completionMar 2017
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 Colitis, UlcerativeStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Klaus Fellermann, MD, Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550418
- Sponsor's protocol ID
- BUX-3/UCA
- Acronym
- TOPICAL-1
- Status last verified
- Jul 2017
- First submitted
- 14 Sep 2015
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Fellermann K, Schiefke I, Racz I, Derova J, Jonaitis L, Wehrum S, Nacak T, Greinwald R. Efficacy and safety of prolonged release budesonide granules in mesalazine-refractory ulcerative colitis: A multi-centre Phase IIa study (TOPICAL-1). United European Gastroenterol J. 2020 Dec;8(10):1186-1195. doi: 10.1177/2050640620962632. Epub 2020 Oct 7.
PubMed 33028169
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multi-centre, Proof of Concept Phase IIa Clinical Trial on the Efficacy and Tolerability of an 8 Week Oral Treatment With Once Daily 9 mg Budesonide in Patients With Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02550418
- Acronym / sponsor ID
- TOPICAL-1 / BUX-3/UCA
- Conditions
- Colitis, Ulcerative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 15 Sep 2015 (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 the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Budesonide | Experimental | Drug: Budesonide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent,
- Men or women aged 18 to 75 years,
- Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology,
- Established disease,
Key exclusion criteria (14 listed)
- Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete microscopic colitis), diverticular disease associated colitis,
- Toxic megacolon or fulminant colitis,
- Colon resection,
- Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening),
- Malabsorption syndromes,
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 |
|---|---|---|
| Budesonide | Drug | Budesonide |
Primary outcome
Rate of clinical remission at final/withdrawal visit
Time frame: 8 weeks treatment
Clinical remission includes normalisation of stool frequency and absence of blood in stools
2 secondary outcomes
Rate of endoscopic remission/improvement at final/withdrawal visit
Time frame: 8 weeks treatment
Number of stools / bloody stools per week
Time frame: 8 weeks treatment
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 26 Jul 2017.
- Derived from this study: PubMed 33028169Fellermann K, Schiefke I, Racz I, Derova J, Jonaitis L, Wehrum S, Nacak T, Greinwald R. Efficacy and safety of prolonged release budesonide granules in mesalazine-refractory ulcerative colitis: A multi-centre Phase IIa study (TOPICAL-1). United European Gastroenterol J. 2020 Dec;8(10):1186-1195. doi: 10.1177/2050640620962632. Epub 2020 Oct 7.
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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.
Klaus Fellermann, MD principal investigator
University Hospital Schleswig-Holstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Budesonide in people with Colitis, Ulcerative, run by Dr. Falk Pharma GmbH 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 4 inclusion and 14 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 26 Jul 2017. 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 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.
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?
Rate of clinical remission at final/withdrawal visit (time frame: 8 weeks treatment). 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 NCT02550418, 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 26 Jul 2017.