Clinical study on the efficacy of Iberogast® (STW 5) in patients with irritable bowel syndrome
- Conditions
- Irritable Bowel Syndrome (IBS)MedDRA version: 20.1Level: PTClassification code 10023003Term: Irritable bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2011-002613-10-DE
- Lead Sponsor
- Steigerwald Arzneimittelwerk GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 237
1. Patients of either sex aged >18 years.
2. Patients meeting the Rome III irritable bowel syndrome (IBS) diagnostic criteria. IBS is defined as recurrent abdominal pain or discomfort at least 3 days/month in last 3 months (onset at least 6 months ago) associated with two or more of the following: 1. Improvement with defecation, 2. Onset associated with a change in frequency of stool, 3. Onset associated with a change in form (appearance) of stool.
3. History of pain intensity with a average of worst abdominal pain in past 24 hours score of > 30 on a daily measured VAS scale during screening phase (a minimum of 8 VAS values, assessed on different days during screening phase, is required).
4. Patients willing to comply with the study protocol.
5. Patients who are able to understand and provide written informed consent to participate in the trial (signed informed consent).
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37
1. Intake of STW 5 within the last 5 years.
2. Concomitant treatment during the study (including screening phase) with any medication that could influence the gastrointestinal function (e.g. opiates, cyclic antidepressants (intake with stable dose since three months is tolerated),
constipating drugs (e.g. medication against Parkinson Disease, Metformin, antipsychotic drugs, analgetics containing opiates, spasmolytics, laxatives, antidiarrheal agents). The use of provided rescue medication during the study treatment is permitted.
3. Regular intake of nonsteroidal antiphlogistic drugs incl. COX-2-inhibitors (exception: acetylsalicylic acid for cardiovascular prevention up to 100 mg daily).
4. Patients with known hypersensitivity to any component of the trial drugs.
5. Severe allergic diathesis.
6. Structural lesions or biochemical abnormalities that can be considered the cause of IBS symptoms.
7. History of eating disorders.
8. Patients with a history of diseases with abdominal symptoms that can resemble IBS, such as:
- History of clinically relevant gastrointestinal disease such as gastric, pancreatic, colon or rectal cancer or gastric and/or duodenal ulcer.
- Uncontrolled thyroid diseases (Hyper- or hypothyreosis).
- Lactose intolerance with complete resolution of symptoms during lactose free diet.
- Known inflammatory bowel diseases.
- Known parasitic or bacterial infections.
- Known malabsorption.
- Known HIV infection.
- Known endometriosis.
- Pseudo-obstruction, myopathy, neuropathy.
- Postsurgical syndromes.
- Chronic pancreatitis.
- Major psychiatric disorders.
- Symptomatic biliary dysfunction or lithiasis.
- History of food allergies and/or celiac sprue.
9. Presence of any other acute or chronic gastrointestinal disorder.
10. Patients with known severe acute or chronic diseases (i.e., cancer, tuberculosis).
11. History of abdominal surgery (cholecystectomy and appendectomy can be tolerated when performed at least one year previously).
12. Mesenteric vascular diseases.
13. Clinically relevant abnormalities in physical and/or biochemical findings at screening examination interfering with the study objectives.
14. History of current or past alcohol or drug abuse.
15. Known intolerance to azo dyes E 110 and E 151.
16. Patients participating in a clinical trial within the last 30 days before Day 1 or with concurrent participation in another clinical trial.
17. Any serious medical condition, which would hinder the patient’s ability to fully comply with the protocol.
18. Female patients of childbearing potential with a positive pregnancy test, breast feeding, or female patients of childbearing potential without adequate contraception.
19. The patient is institutionalized by court or administrative order.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to show the efficacy of STW 5 on pain related symptoms of patients with IBS.;Secondary Objective: The secondary objective is to assess the safety and tolerability of STW 5 and to assess the effect of STW 5 on QoL.;Primary end point(s): Pain Intensity (Responder definition: Decrease of worst abdominal pain in past 24 hours score of = 30% compared with Baseline for a least 14 single days during the treatment period of 4 weeks determined by daily assessment on a VAS);Timepoint(s) of evaluation of this end point: Pain intensity will be assessed daily on a visual analog scale and entered in the patient diary. The diaries for the treatment period will be collected on Visit 3 and Visit 4 (2 weeks and 4 week after randomization)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Pain Intensity (Responder definition: Decrease of worst abdominal pain in past 24 hours score of = 30% compared with Baseline for at least 7 single days within the first 2 weeks of study treatment determined by daily assessment on a VAS)<br>- Stool parameters (stool consistency and stool frequency)<br>- Irritable Bowel Syndrome – Quality of Life Measure (IBS_QOL)<br>;Timepoint(s) of evaluation of this end point: - Pain intensity will be assessed daily on a visual analog scale and entered in the patient diary. The diary for the treatment period will be collected on Visit 3 (2 weeks after randomization)<br>- Stool parameters will be assessed daily in the patientdiary<br>- Irritable Bowel Syndrome – Quality of Life Measure will be asseseed on Visit 2 (Randomization) and Visit 4 (final Study visit)