NCT05192317招募中不适用
A Randomized, Parallel Group, Placebo-controlled, Double Blinded Clinical Trial to Evaluate the Efficacy and Safety of the Substance-based Medical Device (Sollievo Fisiolax) in the Treatment of Chronic Constipation.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 4
- 主要终点
- Change in the number of spontaneous complete bowel movement
研究概览
简要总结
This is a multi-center, randomized, double-blinded placebo controlled trial to evaluate the efficacy and safety of the substance-based medical device (Sollievo Fisiolax) in the treatment of Chronic Constipation.
Treatment period for each patient is 28 days.
详细描述
According to the criteria of Rome IV, 86 patients diagnosed from chronic constipation will be enrolled by up to ten centers.
The study includes 2 visits at the site center and 1 by phone call.
V-1 (eligibility assessment / screening visit):
- Collection of written informed consent
- Physical examination, including measurement of anthropometric parameters and vital signs (height, weight, diastolic / systolic pressure, heart rate)
- Diagnosis according to Rome IV criteria of chronic functional constipation
- Blood tests: glycemia, creatinine, complete blood count with formula, ALT, AST, ALP, calcium, potassium, sodium, C reactive protein, total bilirubin. Urinalysis.
- Performing a colonoscopy for patients aged> 50 who have not had one performed in the last 5 years.
- Guideline for daily diary to collect the number and the consistency of the evacuations, and whether or not they occur with effort
- Recording of adverse events and concomitant therapies
V0 (confirmation of possession of selection criteria):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient giving written informed consent to participate in the study.
- •Patient of both sexes aged between 18 and 70 years (inclusive)
- •Patient affected by chronic functional constipation according to the Rome IV criteria
- •In patients over the age of 50, negative colonoscopy, i.e. absence of clinically relevant alterations or in any case of critical condition for study participation, performed during the run-in period unless:
- •at least negative colonoscopy performed in the previous 5 years the symptoms have remained unchanged, if present, from the time of the execution of the (or last, if more than one) colonoscopy
排除标准
- •Hypersensitivity or Suspected or known allergy to one of the components of the products under study
- •Have previously taken the study product
- •Therapy with antibiotics within 4 weeks prior to the screening visit (i.e, prior to the visit V -1)
- •Therapy within 2 weeks of the run-in (i.e., prior to the visit V0) with: Laxatives / fecal softeners / intestinal bulking products; Drugs indicated for the treatment of obesity; probiotics or prebiotics
- •Chronic inflammatory bowel diseases
- •Intestinal diseases of infectious, actinic, endocrine or pharmacologic origin (microscopic colitis)
- •Patients undergoing gastro-intestinal resection
- •Renal, hepatic, haematological, cardiovascular, pulmonary, neurological, psychiatric, immunological, endocrine diseases, if they are clinically significant
- •Patients with malignant neoplasm of any type, or history of malignancy, with the exclusion of patients with a history of extra-intestinal malignant neoplasm surgically removed and no evidence of recurrence within the five years prior to participation
- •Abuse of alcohol, narcotics or psychotropic drugs that can change vigilance and physical perception
- •Presence of a dementia of any type or other possible causes of progressive deterioration of the capacity to understand and of want or psycho-physical disability that reduces the ability to assume as expected the study treatment
- •Obesity (BMI ≥ 30)
- •No adequate reliability or conditions that may lead to a non-compliance / adherence of the patient to the protocol
- •Previous participation in a clinical trial in the last 30 days
- •Patients who for any reason do not agree to guarantee the commitment to keep their diet stable for the study period
- •During the run-in period, in case of severe symptoms, the use of an evacuant to be applied rectally, indicated in constipation and identified by the Investigator, can be used as a "rescue" therapy.
结局指标
主要结局
Change in the number of spontaneous complete bowel movement
时间窗: 28 days
Response rate (RR) to study treatment, defined by an increase of at least 1 spontaneous complete bowel movement, (SCBM) / weekly from baseline, in at least 75% of the weeks of the treatment period
次要结局
- Change in Stool frequency(through study completion, an average of 1 month)
- Change in Patient Assessment of Constipation-Symptom(14 days, 28 days)
- Incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, incidence of patients dropped outs.(through study completion, an average of 1 month)
- Patient satisfaction(7 days, 14 days, 21 days, 28 days)
- Change in Stool consistency(through study completion, an average of 1 month)
- Rescue medication(through study completion, an average of 1 month)
- Change of Quality of Life (QoL)(14 days, 28 days)
- Change of strain evacuation(through study completion, an average of 1 month)
研究者
研究点 (4)
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