EUCTR2011-002613-10-DE进行中（未招募）1 期
A double-blind, randomised, placebo-controlled study on the efficacy of Iberogast® (STW 5) in patients with irritable bowel syndrome - Double-blind, placebo-controlled STW5 efficacy study in IBS patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 237
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
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