Ulcerative colitis
Conditions
Interventions
Trade Name: Iberogast N
Product Name: Iberogast N
Product Code: STW5-II
Pharmaceutical Form: Oral drops, liquid
INN or Proposed INN: Bitterschleifenblume-ganzpflanze 1,5ml/10ml
Other descriptive name:
Sponsors
Steigerwald Arzneimittelwerk GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with confirmed ulcerative colitis (UC) by symptoms, endoscopy and histology - Patients with mild to moderate active ulcerative colitis (UC), i.e. 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 but not more than 28 days before Visit 2 - Age between 18 to 80 years (including) - UC may reach from left-sided colitis to pancolitis - Willing and able to understand and sign an approved Informed Consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
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 - Topical mesalazin application - 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 - Anticoagulant medication - Any condition or concomitant therapy that in the opinion of the investigator may jeopardize the patients well-being - Total colectomy - Known allergies to components of STW5-II - Severe allergic diathesis - History of current or past alcohol or drug abuse - Known intolerance to azo dyes E110 und E151 - Severe comorbidity - Consumption of any investigational product within one month prior to the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the present study is to assess the efficacy and safety of STW5-II as add-on treatment for induction of remission in patients with mild to moderate ulcerative colitis (UC) in an acute flare, including remission rate, time to remission, Quality of life.;Secondary Objective: Not applicable;Primary end point(s): Remission Rate at final visit (Week 12) investigated with CAI. Responder Definition: patients with Remission. Remission is defined as CAI = 4. - Change of endoscopic index [EI] - Change of histological index [HI] based on Riley - Incidence of sustained remissions (proportion of patients reaching a clinical CAI = 2 points at Week 12 with remission acc. to Rachmilewitz) - Time to remission (CAI = 4 points): days from Day 0 until first remission is reached - Time to sustained remission (CAI = 2 points): days from Day 0 until first sustained remission is reached - Number of patients who reached a remission at least once during the course of the study - Number of patients who reached a sustained remission at least once during the course of the study - Change from baseline of absolute CAI values to final visit (Day 0 to Week 12) - Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visit (Day 0 to Week 12) - Change from baseline in Irritable Bowel Severity Score (IBSS) at final visit (Day 0 to Week 12) - Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visit (Day 0 to Week 12) - (Partial) Mayo Score throughout the study - Determination of changes in UC markers C-reactive protein (CRP), calprotectin, lactoferrin, polymorphonuclear (PMN) elastase for determination of parameters associated with acute flare of UC patients - Change of oral mesalazine dose throughout the study period. ;Timepoint(s) of evaluation of this end point: see E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Germany
Contacts
Public ContactKlinische Forschung
Steigerwald Arzneimittelwerk GmbH
Outcome results
None listed