Clinical trial NCT02246686: Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colitis, Ulcerative
Keywords: Iberogast N
Mild to moderate ulcerative colitis
add-on therapy
efficacy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-09-23
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Total colectomy
* Known allergies to components of STW5-II
* Severe allergic diathesis
* Topical mesalazine application
* Known intolerance to azo dyes E110 and E151

Primary outcomes:
measure: Proportion of patients being in remission at final visit
timeFrame: Week 12
measure: Change of endoscopic index (EI)
timeFrame: From baseline to week 12
measure: Change of histological index (HI) based on Riley
timeFrame: From baseline to week 12
measure: Proportion of patients reaching a clinical CAI ≤ 2 points
timeFrame: Week 12
measure: Time to remission, defined as days from Day 0 until first remission is reached
timeFrame: Up to 12 weeks
measure: Time to sustained remission (CAI ≤ 2 points) defined as days from Day 0 until first sustained remission is reached
timeFrame: Up to 12 weeks
measure: Number of patients who reached a remission at least once during the course of the study
timeFrame: Week 12
measure: Number of patients who reached a sustained remission at least once during the course of the study
timeFrame: Week 12
measure: Change from baseline of absolute CAI values to final visit
timeFrame: From baseline to week 12
measure: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visit
timeFrame: From baseline to week 12
measure: Change from baseline in Irritable Bowel Severity Score (IBSS) at final visit
timeFrame: From baseline to week 12
measure: Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visit
timeFrame: From baseline to week 12
measure: Mayo Score throughout the study
timeFrame: Up to 12 weeks
measure: Change of of oral mesalazine dose throughout the study period
timeFrame: From baseline to week 12
measure: Change in ulcerative colitis (UC) markers
timeFrame: From baseline to week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Dachau
country: Germany
state: Bayern
city: Lüneburg
country: Germany
state: Niedersachsen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Ludwigshafen
country: Germany
state: Rheinland-Pfalz
city: Lübeck
country: Germany
state: Schleswig-Holstein
city: Berlin
country: Germany
city: Essen
country: Germany
city: Hamburg
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: