NCT04804267Unknown3 期
A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate the Clinical Equivalence of Two Linaclotide Products and the Efficacy and Safety of the Test Formulation of Linaclotide in the Treatment of Chronic Idiopathic Constipation
Jiangsu Hansoh Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2021年3月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- The number of spontaneous bowel movements (SBM) during Week 1
研究概览
简要总结
The objective of this study is to evaluate the clinical equivalence of the test formulation of Linaclotide compared to the marketed formulation LINZESS® in patients with Chronic Idiopathic Constipation, and to evaluate the efficacy and safety of the test formulation of Linaclotide in the treatment of Chronic Idiopathic Constipation.
详细描述
This is a randomized, double-blinded, placebo-controlled, multicenter study to evaluate the clinical equivalence of the test formulation of Linaclotide (manufactured by Jiangsu Hansoh Pharmaceutical Co., Ltd.) compared to the marketed formulation LINZESS® in patients with Chronic Idiopathic Constipation.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or nonpregnant females aged ≥ 18 years with a clinical diagnosis of chronic idiopathic constipation defined as < 3 spontaneous bowel movements (SBMs) per week and confirmed by daily diary during baseline period;
- •Have 1 or more of the following symptoms related to bowel movements for the past 3 months with symptom onset at least 6 months before screening and confirmed by daily diary during the 2-week baseline period:
- •lumpy or hard stools for more than 25% of the bowel movements (Bristol Stool Form Scale 1 to 2)
- •sensation of incomplete evacuation following more than 25% of the bowel movements
- •straining at defecation more than 25% of the time 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 life-style changes that may have affected CIC symptoms; Females of child-bearing potential have a negative pregnancy test prior to beginning therapy and agree to use effective contraceptive methods during the study and until 30 days after the last dose; Males who have partners of childbearing potential agree to use effective contraceptive methods during the study and until 30 days after the last dose.
排除标准
- •Meet the Rome IV criteria for Irritable Bowel Syndrome or the Rome IV criteria for Opioid-Induced Constipation; Have a potential central nervous system cause of constipation (e.g., Parkinson's disease, spinal cord injury, and multiple sclerosis, etc.); Have a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility; Subjects with documented mechanical bowel obstruction (e.g., bowel obstruction due to tumor, hernia), megacolon/megarectum, or diagnosis of pseudo-obstruction; Have ever had a fecal impaction that required hospitalization or emergency room treatment, or has a history of cathartic colon, laxative or enema abuse, ischemic colitis, or pelvic floor dysfunction (unless successful treatment has been documented by a normal balloon expulsion test); Subjects with known or suspected organic disorders of the large or small bowel (e.g., inflammatory bowel disease, ulcerative colitis, Crohn's Disease); Subjects with constipation secondary to a documented cause (e.g., surgery, bowel resection); Diagnosis or family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or any other form of familial colorectal cancer; Have a history of cancer other than treated basal cell or squamous cell carcinoma of the skin in the past 5 years; Have currently unexplained and clinically significant alarm symptoms (lower GI bleeding [rectal bleeding or heme-positive stool], anemia, weight loss) or systemic signs of infection or colitis; Have currently active peptic ulcer disease; Have a history of diabetic neuropathy; Have untreated hypothyroidism or treated hypothyroidism for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of the Screening Visit; Have a history of diverticulitis or any chronic condition (e.g., chronic pancreatitis, polycystic kidney disease, ovarian cysts, endometriosis) that can be associated with abdominal pain or discomfort and could confound the assessments in this trial; Have clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or clinically significant laboratory abnormalities, ineligible to participate in the study as determined by the investigator; Have a history of drug or alcohol abuse in the past 12 months before screening; Bariatric surgery for treatment of obesity or surgery to remove a segment of the GI tract at any time before screening; any gastrointestinal or abdominal surgical procedure during the 3 months before screening; any other major surgery during the 30 days before screening; Use of systemic antibiotics within 4 weeks prior to enrolment; Unwilling or unable to abide by the restrictions regarding use of prohibited medicines; Have received any investigational drug during the 3 months before screening.
研究组 & 干预措施
Experimental
Experimental
Linaclotide Manufactured by Jiangsu Hansoh Pharmaceutical Co., Ltd. Drug: Linaclotide 145μg orally once daily
干预措施: Linaclotide (Drug)
Active Comparator
Active Comparator
LINZESS® Manufactured by Almac Pharma Services Limited Drug: Linaclotide 145μg orally once daily
干预措施: LINZESS® (Drug)
Placebo Comparator
Placebo Comparator
Placebo Drug: Placebo orally once daily
干预措施: Placebo (Drug)
结局指标
主要结局
The number of spontaneous bowel movements (SBM) during Week 1
时间窗: 1 week
次要结局
- The proportion of patients with 12-Week CSBM frequency rate (CSBMs/week) ≥3(12 week)
- Change From Baseline in 12-Week Constipation Severity Assessment (five-point ordinal scale)(12 week)
- Percentage of 12-Week complete spontaneous bowel movements (CSBMs) overall responders(12 week)
- The number of CSBM during Week 1 compared to baseline(1 week)
- Time to first SBM after the first dose(up to 1 week)
- Change From Baseline in 12-Week Stool Consistency Assessment (seven-point ordinal Bristol Stool Form Scale)(12 week)
- Change From Baseline in 12-Week Severity of Straining Assessment (five-point ordinal scale)(12 week)
- Change From Baseline in 12-Week Bloating Assessment (five-point ordinal scale)(12 week)
- The proportion of patients with a SBM within 24 hours of receiving the first dose(24 hours after the first dose)
- Change from baseline in 12-Week CSBM frequency rate (CSBMs/week)(12 week)
- Change from baseline in 12-Week SBM frequency rate (SBMs/week)(12 week)
- Change From Baseline in 12-Week Abdominal Discomfort Assessment (five-point ordinal scale)(12 week)
- Change From Baseline in PAC-QOL score (Patient Assessment of Constipation Quality of Life questionnaire)(12 week)
研究者
研究点 (1)
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