A Randomized, Double-blinded, Parallel, Placebo-controlled, Multicenter, bioequivalence study with clinical endpoint to assess efficacy and safety of Linaclotide 145 mcg capsule (manufactured by Arab Pharmaceutical Manufacturing PSC, Jordan for Hikma Pharmaceuticals (MAH)) to LINZESS® (linaclotide) 145 mcg capsules (Allergan USA, Inc. Madison, NJ 07940) in the treatment of chronic idiopathic constipation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 17
- 主要终点
- • Primary Objective: To evaluate bioequivalence by establishing equivalence between Linaclotide 145 mcg capsule (Hikma Pharmaceuticals LLC, Jordan) to LINZESS® (linaclotide) 145 mcg capsules (Allergan USA) in the treatment of chronic idiopathic constipation.
研究概览
简要总结
This will be a randomized, double-blinded, parallel, placebo-controlled, multicenter, bioequivalence study with clinical endpoint to assess efficacy and safety of Linaclotide 145 mcg capsule (Hikma Pharmaceuticals LLC, Jordan) as compared to LINZESS® (linaclotide) 145 mcg capsules (Allergan USA, Inc. Madison, NJ 07940) in the treatment of chronic idiopathic constipation at multiple clinical trial sites in India.
Each study patient will self-administer one capsule of test, reference or placebo product orally once daily, for 1 week.
Primary endpoint and secondary end point(s) assessment will be done at Visit 4 (Day 4 ± 1 day) and Visit 5 (1 week +2 days) for each study patient deemed eligible for evaluation.
Total duration of study will be at least 35 +2 days including screening period of Max 14 days, pre-treatment period of Max 14 days and treatment period 7 + 2 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Brief inclusion as below,
- •Male or female more than and equal to 18 years with a clinical diagnosis of chronic idiopathic constipation (CIC).
- •Ability to provide written informed consent for the study.
- •Have 1 or more of the following symptoms related to bowel movements: • Lumpy or hard stools for more than 25% of the bowel movements • Sensation of incomplete evacuation following more than 25% of the bowel movements.
- •â€¢ Straining at defecation more than 25% of the time.
- •Meet the colonoscopy requirements defined by the American Gastroenterological Association (AGA) guidelines.
- •Willing to discontinue any laxatives used before the Pretreatment Visit in favor of the protocol-defined Rescue Medicine.
- •Agree to refrain from making any new major lifestyle changes that may have affected CIC symptoms from the time of screening to the last trial visit.
- •Free from any clinically significant disease.
- •Comply with protocol & Investigator visit requirements.
排除标准
- •Pregnant, breastfeeding, or planning a pregnancy.
- •Subject with evidence of weight loss, anemia, or rectal bleeding or documented colonoscopy performed during the 6 months prior to dosing.
- •Documented mechanical bowel obstruction, megacolon/megarectum, or diagnosis of pseudo-obstruction.
- •GI track Structural abnormality or a disease or condition that could affect GI motility
- •Fecal impaction that required hospitalization or emergency room treatment, or had a history of cathartic colon, laxative or enema abuse, ischemic colitis, or pelvic floor dysfunction.
- •Meet the Rome IV criteria for Irritable Bowel Syndrome or Opioid-Induced Constipation.
- •Diagnosis or family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or any other form of familial colorectal cancer.
- •Current active peptic ulcer disease
- •History of diabetic neuropathy, diverticulitis or any chronic condition that could be associated with abdominal pain or discomfort
- •History of Bariatric surgery or surgery to remove a segment of the GI tract 6 months before the Screening Visit, major surgery within 4 weeks prior to study, an appendectomy or cholecystectomy during the 60 days before the Screening Visit, or other major surgery during the 30 days before the Screening Visit.
- •Potential central nervous system cause of constipation
- •Untreated hypothyroidism or treated hypothyroidism for which the dose of thyroid hormone had not been stable for at least 6 weeks at the time of the Screening Visit
- •Hospitalized for any gastrointestinal or abdominal surgical procedure during the 3 months prior to dosing.
- •Clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or hematologic and/or biochemical abnormalities based on laboratory testing.
- •Used Rescue Medicine or any other laxative, suppository, or enema, on the calendar day before or the calendar day of the start of the Treatment Period.
- •Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery.
- •Positive for drugs of abuse or Breath alcohol analyzer test prior to receiving the first dose/baseline of the investigational medicinal product in the study.
- •Receipt of an investigational medicinal product or participation in another drug research study within 30 Days.
结局指标
主要结局
• Primary Objective: To evaluate bioequivalence by establishing equivalence between Linaclotide 145 mcg capsule (Hikma Pharmaceuticals LLC, Jordan) to LINZESS® (linaclotide) 145 mcg capsules (Allergan USA) in the treatment of chronic idiopathic constipation.
时间窗: Primary endpoint and secondary end point assessment will be done at Visit 4 (Day 4) and Visit 5 (1 weeks) for each study patient deemed eligible for evaluation
•Primary Endpoint: Number of spontaneous bowel movement (SBM) during Week 1 (study Days 1-7), compared to baseline.
时间窗: Primary endpoint and secondary end point assessment will be done at Visit 4 (Day 4) and Visit 5 (1 weeks) for each study patient deemed eligible for evaluation
Note: An SBM is defined as any bowel movement that did not occur within 24 hours after rescue medication use.
时间窗: Primary endpoint and secondary end point assessment will be done at Visit 4 (Day 4) and Visit 5 (1 weeks) for each study patient deemed eligible for evaluation
次要结局
- • Secondary Objective :To assess the safety and tolerability profile of the reference product & test product.(To demonstrate statistical superiority of both the Test and Reference products over Placebo in terms of clinical endpoint efficacy.)