Colitis, UlcerativePhase 2NCT02246686
Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients
A Phase 2 study testing STW5-II (Iberogast N, BAY98-7410) in people with Colitis, Ulcerative, run by Bayer at 8 sites in Germany.
Trial summary
The study will investigate efficacy of STW5-II as add-on therapy on the rate to remission in patients with mild to moderate ulcerative colitis in an acute flare. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- STW5-II (Iberogast N, BAY98-7410)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 8 sitesGermany
- Study dates
- Nov 2014to Apr 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mild to moderate active ulcerative colitis (UC), i.e. Clinical Activity Index (CAI) ≥ 5 up to 10 points (including)
- Patients in whom the active UC is treated independent from any participation in the current study with oral mesalazine at least 14 days up to maximal 28 days before Visit 2
- Age between 18 to 80 years (including)
- UC may reach from left-sided colitis to pancolitis
Who cannot join
- Severe forms of UC (CAI > 10)
- Crohn's disease, infectious colitis or undetermined colitis
- Steroid dependence and steroid resistance
- Concomitant medication with oral steroids, oral or topic budesonide, biologicals, immune modifiers, immunosuppressants
- Antibiotics at screening visit, during the course of the study a short-term use in non-colitic afflictions is allowed, and is documented
- Prior medication with biologicals, immune modifiers and immunosuppressants < 3 month wash-out
Show all 11Show fewer
- Total colectomy
- Known allergies to components of STW5-II
- Severe allergic diathesis
- Topical mesalazine application
- Known intolerance to azo dyes E110 and E151
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Study site
Berlin, 14109
Study site
Cologne, North Rhine-Westphalia, 50937
Study site
Dachau, Bavaria, 85221
Study site
Essen, 45276
Study site
Hamburg, Free and Hanseatic City of Hamburg, 20249
Study site
Lübeck, Schleswig-Holstein, 23538
Study site
Ludwigshafen am Rhein, Rhineland-Palatinate, 67067
Study site
Lüneburg, Lower Saxony, 21339
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Multi-centre Study to Investigate the Effectiveness and Safety of STW5-II as add-on Treatment for Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis
The study will investigate efficacy of STW5-II as add-on therapy on the rate to remission in patients with mild to moderate ulcerative colitis in an acute flare.
- Conditions
- Colitis, Ulcerative
- Being tested
- STW5-II (Iberogast N, BAY98-7410), Placebo
- Keywords
- Iberogast N, Mild to moderate ulcerative colitis, add-on therapy, efficacy
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STW5-II (Iberogast N, BAY98-7410)Drug
Application over 12 weeks 20 drops three time daily
PlaceboDrug
Application over 12 weeks 20 drops three time daily
| Study group | Role | What they receive |
|---|---|---|
| STW5-II | Experimental | Half of study population, assigned randomly Receives: Drug: STW5-II (Iberogast N, BAY98-7410) |
| Placebo | Placebo comparator | Half of study population, assigned randomly Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients being in remission at final visit
Responder definition for remission: Clinical Activity Index (CAI) ≤ 4
Measured: Week 12
Change of endoscopic index (EI)
Measured: From baseline to week 12
Change of histological index (HI) based on Riley
Measured: From baseline to week 12
Proportion of patients reaching a clinical CAI ≤ 2 points
Measured: Week 12
Time to remission, defined as days from Day 0 until first remission is reached
Responder definition for remission: Clinical Activity Index (CAI) ≤ 4
Measured: Up to 12 weeks
Time to sustained remission (CAI ≤ 2 points) defined as days from Day 0 until first sustained remission is reached
Measured: Up to 12 weeks
Number of patients who reached a remission at least once during the course of the study
Measured: Week 12
Number of patients who reached a sustained remission at least once during the course of the study
Measured: Week 12
Change from baseline of absolute CAI values to final visit
Measured: From baseline to week 12
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visit
Measured: From baseline to week 12
Change from baseline in Irritable Bowel Severity Score (IBSS) at final visit
Measured: From baseline to week 12
Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visit
Measured: From baseline to week 12
Mayo Score throughout the study
Measured: Up to 12 weeks
Change of of oral mesalazine dose throughout the study period
Measured: From baseline to week 12
Change in ulcerative colitis (UC) markers
Combination of four markers C-reactive protein (CRP), calprotectin, lactoferrin, polymorphonuclear (PMN) elastase for determination of parameters associated with acute flare of UC patients
Measured: From baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startNov 2014
- Primary completionFeb 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by BayerThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246686
- Sponsor's protocol ID
- 17155
- Other IDs
- 2013-000891-13
- Status last verified
- Oct 2016
- First submitted
- 19 Sep 2014
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Multi-centre Study to Investigate the Effectiveness and Safety of STW5-II as add-on Treatment for Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02246686
- Acronym / sponsor ID
- 17155
- Conditions
- Colitis, Ulcerative
- Keywords
- Iberogast N, Mild to moderate ulcerative colitis, add-on therapy, efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 23 Sep 2014 (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 will investigate efficacy of STW5-II as add-on therapy on the rate to remission in patients with mild to moderate ulcerative colitis in an acute flare.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STW5-II | Experimental | Drug: STW5-II (Iberogast N, BAY98-7410)Half of study population, assigned randomly |
| Placebo | Placebo comparator | Drug: PlaceboHalf of study population, assigned randomly |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with mild to moderate active ulcerative colitis (UC), i.e. Clinical Activity Index (CAI) ≥ 5 up to 10 points (including)
- Patients in whom the active UC is treated independent from any participation in the current study with oral mesalazine at least 14 days up to maximal 28 days before Visit 2
- Age between 18 to 80 years (including)
- UC may reach from left-sided colitis to pancolitis
Key exclusion criteria (11 listed)
- Severe forms of UC (CAI > 10)
- Crohn's disease, infectious colitis or undetermined colitis
- Steroid dependence and steroid resistance
- Concomitant medication with oral steroids, oral or topic budesonide, biologicals, immune modifiers, immunosuppressants
- Antibiotics at screening visit, during the course of the study a short-term use in non-colitic afflictions is allowed, and is documented
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 |
|---|---|---|
| STW5-II (Iberogast N, BAY98-7410)Application over 12 weeks 20 drops three time daily | Drug | STW5-II |
| PlaceboApplication over 12 weeks 20 drops three time daily | Drug | Placebo |
Primary outcome
Proportion of patients being in remission at final visit
Time frame: Week 12
Responder definition for remission: Clinical Activity Index (CAI) ≤ 4
Change of endoscopic index (EI)
Time frame: From baseline to week 12
Change of histological index (HI) based on Riley
Time frame: From baseline to week 12
Proportion of patients reaching a clinical CAI ≤ 2 points
Time frame: Week 12
Time to remission, defined as days from Day 0 until first remission is reached
Time frame: Up to 12 weeks
Responder definition for remission: Clinical Activity Index (CAI) ≤ 4
Time to sustained remission (CAI ≤ 2 points) defined as days from Day 0 until first sustained remission is reached
Time frame: Up to 12 weeks
Number of patients who reached a remission at least once during the course of the study
Time frame: Week 12
Number of patients who reached a sustained remission at least once during the course of the study
Time frame: Week 12
Change from baseline of absolute CAI values to final visit
Time frame: From baseline to week 12
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visit
Time frame: From baseline to week 12
Change from baseline in Irritable Bowel Severity Score (IBSS) at final visit
Time frame: From baseline to week 12
Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visit
Time frame: From baseline to week 12
Mayo Score throughout the study
Time frame: Up to 12 weeks
Change of of oral mesalazine dose throughout the study period
Time frame: From baseline to week 12
Change in ulcerative colitis (UC) markers
Time frame: From baseline to week 12
Combination of four markers C-reactive protein (CRP), calprotectin, lactoferrin, polymorphonuclear (PMN) elastase for determination of parameters associated with acute flare of UC patients
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
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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.
Bayer Study Director study director
Bayer
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STW5-II (Iberogast N, BAY98-7410) in people with Colitis, Ulcerative, run by Bayer at 8 sites 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 11 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 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. 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.
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 was stopped early. 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?
Proportion of patients being in remission at final visit (time frame: Week 12). The study lists 15 primary outcomes in all. 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 18 Oct 2016.