Study with the herbal preparation STW5-II in patients with mild to moderate ulcerative colitis (chronic inflammatory bowel disease)

• Register: EUCTR
• Last refreshed on: 12 October 2015
• Main ID: EUCTR2013-000891-13-DE
• Date of registration: 24/06/2014
• Prospective Registration: Yes
• Primary sponsor: Steigerwald Arzneimittelwerk GmbH
• Public title: Study with the herbal preparation STW5-II in patients with mild to moderate ulcerative colitis (chronic inflammatory bowel disease)
• Scientific 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 colitits
• Date of first enrolment: 21/07/2014
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000891-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Germany

Contacts

• Name: Klinische Forschung
• Affiliation: Steigerwald Arzneimittelwerk GmbH

• Name: Klinische Forschung
• Affiliation: Steigerwald Arzneimittelwerk GmbH

Key inclusion & exclusion 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:
- 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Ulcerative colitis

Intervention(s)

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: BITTER CANDYTUFT FRESH PLANT EXTRACT
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 15-
INN or Proposed INN: Kümmel 2ml/10ml
Other descriptive name: CARVI EXTRACTUM FLUIDUM
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: Pfefferminzblätter 1ml/10ml
Other descriptive name: MENTHA × PIPERITA L. FOLIUM
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 10-
INN or Proposed INN: Süßholzwurzel 1ml/10ml
Other descriptive name: GLYCYRRHIZA GLABRA ROOT
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 10-
INN or Proposed INN: Kamillenblüten 3ml/10ml
Other descriptive name: MATRICARIA RECUTITA L. FLOS
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 30-
INN or Proposed INN: Melissenblätter 15ml/10ml
Other descriptive name: MELISSAE FOLII DRY AQUEOUS EXTRACT
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Oral drops, liquid
Route of administration of the placebo: Oral use

Primary Outcome(s)

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.

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.

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: see E.5.1

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Not applicable

Secondary end point(s): Not applicable

Secondary ID(s)

STW5-II/212-D-12-II-F;IMP17155

Source(s) of Monetary Support

Steigerwald Arzneimittelwerk GmbH