PER-006-21进行中（未招募）3 期
CLINICAL STUDY, DOUBLE-BLIND, RANDOMIZED TO EVALUATE THE EFFICACY AND SAFETY OF SODIUM PICOSULPHATE 2.5MG /100ML (CALORIE-FREE MARKOS PURGANT LEMONADE), PLACEBO CONTROLLED IN PATIENTS WITH FUNCTIONAL CHRONIC CONSTIPATIO
ABORATORIOS FARMACEUTICOS MARKOS S.A0 个研究点目标入组 276 人开始时间: 2021年6月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 276
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. Participants of both sexes between 18 to 60 years of age
- •2. Have a diagnosis of functional chronic constipation, according to their medical history as defined by the Rome IV diagnostic criteria. Criteria met during the last 3 months with onset of symptoms at least 6 months before diagnosis.
- •a) Presence of two or more of the following criteria:
- •Excessive straining in at least 25% of stools
- •Hard stools in at least 25% of stools (Bristol type 1-2)
- •Feeling of incomplete evacuation in at least 25% of stools
- •Anorectal blockage or blockage sensation in at least 25% of bowel movements
- •Manual maneuvers to facilitate defecation in at least 25% of bowel movements
- •Less than three complete spontaneous bowel movements a week
- •b) The presence of liquid stools is rare without the use of laxatives
- •c) There should not be sufficient criteria for the diagnosis of Irritable Bowel Syndrome
- •3. Able and willing to complete a log journal.
- •4. Written informed consent signed and dated prior to study enrollment in accordance with GCP and local legislation
排除标准
- •Patient with a history or clinical suspicion at the time of medical evaluation of the following entities:
- •1. Eating disorders such as anorexia nervosa and bulimia, as a cause of excessive use of laxatives.
- •2. Patients whose constipation is caused by a primary organic disease of the colon or pelvic floor.
- •3. Patients with metabolic disorders, neurological disorders, serious psychiatric disorders, or any other significant or intercurrent illness (eg, abdominal / gastrointestinal surgery) that, in the opinion of the investigators, would interfere with participation in the trial.
- •4. Patients with a disability that restricts their spontaneous mobility (eg, in a wheelchair or in bed)
- •5. Patients with known hypersensitivity to sodium picosulfate, bisacodyl, or any other ingredient in the study medication.
- •6. Patients with ileus, intestinal obstruction, acute surgical abdominal conditions (such as acute appendicitis and acute inflammatory bowel diseases) or severe dehydration
- •7. Patients with anal fissures or ulcerative proctitis with mucosal damage.
- •8. Patients with known clinically significant abnormal electrolyte values.
- •9. Patients whose concomitant therapy includes an opioid medication (eg, morphine, codeine) or anticholinergics
- •10. Patients unwilling to discontinue use of prohibited concomitant therapy
- •11. Pregnant or lactating women
- •12. Participate concomitantly in another trial
- •13. Drug or alcohol abuse
- •14. Concomitant use of antibiotics
- •15. Therapy with other drugs of similar action within 02 weeks before the screening visit
- •.16. Use of potassium-sparing diuretics or potassium supplements, chronic or excessive use of laxatives can reduce the serum concentration of potassium by promoting an excessive loss of potassium in the intestinal tract.
- •17. Use of Antiarrhythmics (quinidine type): Sotalol, amiodarone, vincamine, digitalis.
- •18. Inflammatory bowel diseases (ulcerative colitis, Crohn's disease).
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