ISRCTN46930204已完成未知
Randomised, double-blind, placebo-controlled, multicentre trial for investigation of SYN-001 in the treatment of patients with chronic idiopathic constipation
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 204
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 chronic idiopathic constipation according to current EMA-Guideline:
- •1.1. A patient must fulfil 2 or more of the following 3 criteria:
- •1.1.1. Fewer than 3 defecations per week
- •1.1.2. Straining during at least 25% of defecations
- •1.1.3. Lumpy or hard stools in at least 25% of defecations
- •1.2. A patient must fulfil all of the following:
- •1.2.1. Loose stools (type 6 or 7 on the Bristol Stool Scale) are rarely present without the use of laxatives at visit 1 and occurs during the run-in period on less than 3 days
- •1.2.2. No defecation disorders
- •1.2.3. Insufficient criteria for irritable bowel syndrome according to the Rome III criteria
- •1.2.4. No other causes are identifiable for constipation (e.g. medication)
- •These criteria should be fulfilled at recruitment (by history taking), and during the run-in period of the studies.
- •In addition to that, during the Run-In period, the number of stools should not exceed 5 in two weeks.
- •2. Otherwise healthy
- •3. Aged 18-80 years
- •4. Negative result of a sigmoidoscopy or colonoscopy within the preceding 5 years for patients above 55 years of age
- •5. Legal capacity
- •6. Written consent of the patient
- •7. Understanding of the German language and compliance
- •8. Understanding that changes in lifestyle and nutrition habits have to be avoided
- •9. Understanding the principle of the patient diary and is willing to keep it according to the requirements
- •10. Negative pregnancy test in women capable of bearing children
排除标准
- •1. Hypersensitivity towards the study product or Bisacodyl
- •2. New symptoms during the last weeks, such as anemia, rectal bleeding, positive fecal occult blood test or severe weight loss
- •3. Secondary reasons for constipation:
- •3.1. Intake of medicaments (e.g. opioids, tricyclic antidepressants, duretics)
- •3.2. Organic/metabolic/neurological diseases (e.g. hypercalcemia, anemia, dementia, collagenosis, Parkinson's disease, multiple sclerosis, Hirschsprung's disease)
- •3.3. Bowel dysfunction (e.g. structural intestinal passage disorder, bowel obstruction, slow-transit-constipation, intestinal stenosis)
- •3.4. Eating disorders (e.g. anorexia, bulimia)
- •3.5. Physical inactivity
- •3.6. Eating disorder
- •4. Fluid intake of <0.5 l of fluid per day
- •5. Inadequate response to usual laxatives (psyllium, sauerkraut juice, Dulcolax, Lefax, Lacoberal, Bisacodyl)
- •6. Inflammatory bowel diseases (Crohn's disease and Ulcerative colitis)
- •7. Systemic diseases, cancer, autoimmune diseases
- •8. Known abnormalities in abdomen region e.g. unusual ultrasound that would require further investigation
- •9. Ileus, bowel obstruction or acute surgical conditions
- •10. Defecation disorders
- •11. Irritable bowel syndrome
- •12. Surgical intervention within the next 3 months
- •13. Current cancer diagnosis or cancer within the last 5 years or any colorectal cancer diagnosis
- •14. Ingestion of any of the following:
- •14.1. Opioids within the last 6 months prior to study start
- •14.2. Antipsychotics/antideperessants within the last 3 months prior to study start
- •14.3. Antibiotics within the last 2 months prior to study star
- •14.4. Systemic corticosteroids within the last month prior to study start
- •14.5. Medications that may affect the efficacy of the study product (e.g. analgesics, antibiotics, chemotherapeutics, psychotropics/antidepressants, laxatives, spasmolytics, antidiarrhoeals, probiotic products)
- •15. Serious psychiatric disorders within the last 2 years
- •16. Diabetes mellitus
- •17. Hyperthyroidism and non-set hypothyroidism
- •18. Immune deficiency
- •19. Abdominal surgeries (exceptions include: appendectomies, hernia surgeries, cholecystectomy and sectio caesarea if undertaken more than 6 months prior to study start)
- •20. Coeliac disease
- •22. Known parasites or eggs in stool
- •23. Serious diseases resulting in a need for care, a need for a guardian or resulting in immobilisation
- •24. Gynecological diseases
- •25. Alcohol or drug abuse
- •26. Pregnancy or lactation period
- •27. Participation in other interventional trials or participation in other interventional trials within the last 30 days
- •28. 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 pressuring the participant
- •29. Accommodation in an asylum due to court or administrative order
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