ISRCTN15026454已完成未知
Investigation of RM-001 in a double-blind, placebo-controlled, multicenter study in patients with upset stomach (functional dyspepsia) and related symptoms
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 124
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with upset stomach (functional dyspepsia) and related symptoms. A patient must fulfil the following:
- •1.1 One or more of the following symptoms occurs on at least 3 days per week with at least moderate intensity:
- •- postprandial fullness
- •- early satiation
- •- gastric pain
- •- gastric burning
- •1.2 Fulfillment of symptom criteria at recruitment (by history taking), and during the Run-in period of the study with onset of the symptoms more than 6 months prior to study start.
- •1.3 Presence of a malignant disease, which causes the dyspeptic symptoms, is to be excluded by the investigator on the basis of the current medical history and preliminary findings
- •2. Aged 18-80 years
- •3. Capacity for consent
- •4. Written informed consent of the patient
- •5. Understanding of the German language and compliance
- •6. Patient has understood, that changes in lifestyle and nutrition habits have to be avoided
- •7. Patient has understood the principle of the patient-diary and is willing to keep it according to the requirements
- •8. Negative pregnancy test in women capable of bearing children
排除标准
- •1. Hypersensitivity towards enzymes or allergy to mould
- •2. Familial predisposition (first degree) with GI carcinoma if the presence of carcinoma has not been excluded by gastroscopy within the last 5 years
- •3. Acute or recurrent occurence of alarm symptoms (anemia, unintentional weight loss (>10% of body weight), fever, lymph node enlargement, hematemesis, vomiting, melena)
- •4. Organic diseases: esophagitis, GERD, Barrett's esophagus, gastritis, pancreatitis, exocrine pancreatic insufficiency
- •5. Other diseases: diabetes, chronic inflammatory bowel disease, diverticulitis, liver disease, disease of the genitourinary system, cholecystitis and presence of gallstones, dysphagia, odynophagia, ulcus in the digestive tract, malabsorption
- •6. Infectious and parasitic causes and acute infections and parasitic infection
- •7. Systemic diseases, current cancer diagnosis or cancer within the last 5 years or any cancer diagnosis of the upper digestive tract (esophagus, stomach, duodenum), autoimmune diseases
- •8. Hyperthyroidism and unstable hypothyroidism
- •9. Hypercalcemia, hypercalciuria, kidney stones or calcification of the kidney
- •10. Food intolerances, celiac disease
- •11. Current pathological abdominal palpation or ultrasound findings
- •12. Abdominal surgeries (exceptions include: appendectomies, hernia surgeries, cholecystectomy and sectio caesarea if undertaken more than 6 months prior to study start)
- •13. Psychiatric or eating disorders within the last 2 years
- •14. Medications that may affect the efficacy of the study product (e.g. prokinetics, proton pump inhibitors, H2 receptor antagonists, phytotherapeutics, antidepressants or psychotropic drugs (no use within the last 3 months), antibiotics (no intake within the last 2 months), systemic corticosteroids (no use within the last month), chronic use of NSAID (except ASA 100 mg as a blood thinner), thiazide-type diuretics, cardiac glycosides)
- •15. Predominant symptoms of irritable bowel syndrome (patient primarily suffering from defecation disorders such as diarrhea or constipation)
- •16. Predominant symptoms of reflux oesophagitis (patient primarily suffering from heartburn)
- •17. Pregnancy or lactation period
- •18. A need for care, guardian or immobilisation
- •19. Alcohol or drug abuse
- •20. Participation in other interventional trials or participation in other interventional trials within the last 30 days
- •21. Nonautonomous individuals, not capable of making decisions independently e.g. due to a relationship with a sponsoring party or relationship with a physician, both of whom may be capable of putting pressure on the participant
- •22. Accommodation in an asylum due to court or administrative order
研究者
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