TerminatedPhase 2

Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients

Germany3 participantsStarted 2014-11

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of patients being in remission at final visit

Timeframe: Week 12

Change of endoscopic index (EI)

Timeframe: From baseline to week 12

Change of histological index (HI) based on Riley

Timeframe: From baseline to week 12

Proportion of patients reaching a clinical CAI ≤ 2 points

Timeframe: Week 12

Time to remission, defined as days from Day 0 until first remission is reached

Timeframe: Up to 12 weeks

Time to sustained remission (CAI ≤ 2 points) defined as days from Day 0 until first sustained remission is reached

Timeframe: Up to 12 weeks

Number of patients who reached a remission at least once during the course of the study

Timeframe: Week 12

Trial details

NCT IDNCT02246686

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-02

View on ClinicalTrials.gov More Colitis, Ulcerative trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Proportion of patients being in remission at final visit

Timeframe: Week 12

Change of endoscopic index (EI)

Timeframe: From baseline to week 12

Change of histological index (HI) based on Riley

Timeframe: From baseline to week 12

Proportion of patients reaching a clinical CAI ≤ 2 points

Timeframe: Week 12

Time to remission, defined as days from Day 0 until first remission is reached

Timeframe: Up to 12 weeks

Time to sustained remission (CAI ≤ 2 points) defined as days from Day 0 until first sustained remission is reached

Timeframe: Up to 12 weeks

Number of patients who reached a remission at least once during the course of the study

Timeframe: Week 12