A Multicenter observational cohort study of use of PERT in patients with Pancretic Exocrine Insufficiency with Type II Diabetes Mellitus in India
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- The change in mean abdominal symptom score on the PEI-Q will be summarized at Day 30 using descriptive measures as well as 95 percent CI of the mean. A paired t-test (if data normal) or Wilcoxon signed-rank test will be performed at the 5 percent level to assess the significance of the change from baseline
研究概览
简要总结
1.Primary Objective
• To evaluate the effectiveness of Pancreatin enteric-coated capsule on improvement in abdominal symptoms like abdominal pain and bloating at day 30 of treatment in patients of PEI with T2DM.
- Secondary Objective(s)
• To evaluate the effectiveness of Pancreatin enteric-coated capsule on improvement in abdominal symptoms like abdominal pain and bloating at day 15 of treatment in patients of PEI with T2DM.
• To evaluate the effectiveness of Pancreatin enteric-coated capsule on improvement in bowel movement symptoms like stool frequency, form, and consistency at day 15 and day 30 of treatment in patients of PEI with T2DM.
3.Safety Objectives:
• Evaluate safety of Pancreatin enteric-coated capsule in T2DM patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients meeting all the following criteria are eligible for participation in the study:
- •Male or female adult patients aged 18 years to 65 years.
- •Known case of T2DM with confirmed diagnosis of PEI based on clinical and biochemical assessment (meeting both of following criteria) a.
- •Biochemical diagnosis will be based on criteria with patients meeting FE-1 values less than 200 μg/g.
- •Symptomatic diagnosis will be based on presence of any of the following symptoms: steatorrhea, abdominal pain, weight loss, diarrhea, bloating, and foul-smelling and greasy stools.
- •Patient prescribed Pancreatin enteric-coated capsule as per approved label.
- •Patient willing to give written informed consent to participate into the study.
- •Willing to take the study drug as prescribed by the investigator.
- •Willing to comply with the protocol requirements.
排除标准
- •A patient will be excluded from the study if they meet any of the following criteria:
- •Patients requiring hospitalization due to severe nature of disease.
- •Patients with severe cardiac, renal or hepatic disease
- •Malignancy involving the digestive tract in the past 5 years
- •Patients who have recently undergone major surgery (excluding appendectomy or gall-bladder removal).
- •Contraindications to PERT treatment, including hypersensitivity to active substance, porcine proteins, pancreatin or any ingredient.
- •Use of any PERT within 30 days prior to study enrollment
- •Women of childbearing potential with a positive urine pregnancy test during screening or unwillingness to use an effective form of birth control during the study.
- •Any condition or unsuitable reasons that in the opinion of the investigator does not justify the patient’s inclusion in the study.
结局指标
主要结局
The change in mean abdominal symptom score on the PEI-Q will be summarized at Day 30 using descriptive measures as well as 95 percent CI of the mean. A paired t-test (if data normal) or Wilcoxon signed-rank test will be performed at the 5 percent level to assess the significance of the change from baseline
时间窗: 30 Days
次要结局
- The change in mean abdominal symptom score at Day 15 and change(in mean bowel movement symptom score on the PEI-Q at Days 15 and 30 will be analyzed)
研究者
Mr Jamnadas Kushwaha
Raptim Research private Ltd