CTRI/2015/11/006358尚未招募3 期
Efficacy and Safety of SPILâ??s Lubiprostone capsule, 24 mcg lubiprostone in subjects with Chronic Idiopathic Constipation: A Randomized, Double blind, Parallel group, Active and Placebo Controlled, Clinical Endpoint Bioequivalence Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,425
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
入选标准
- •1.Males and non pregnant females aged >= 18 years
- •2.Subjects with a clinical diagnosis of chronic idiopathic constipation defined as, on average, < 3 spontaneous bowel movements (SBMs) per week and confirmed by daily diary during the 2-week baseline/washout period. An SBM is defined as any bowel movement that did not occur within 24 hours after rescue medication use.
- •3.Have 1 or more of the following symptoms related to bowel movements for at least 6 months before the baseline visit and confirmed by daily diary during the 2-week baseline/washout period:
- •very hard (little balls) and/or hard stools for at least 25% of the bowel movements
- •sensation of incomplete evacuation following at least 25% of the bowel movements
- •straining at defecation at least a quarter of the time
- •4.Women of child bearing potential practising an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injectable contraceptives] from at least 3 months prior to study entry and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative urine pregnancy test.
- •5.For subjects aged < 50 years, documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed within the 5 years prior to dosing, showing no mechanical bowel obstruction or organic disorders of the large or small bowel.
- •6.For subjects aged >= 50 years, documentation of the results of either a barium enema with flexible sigmoidoscopy or colonoscopy performed within 1 year prior to dosing, showing no mechanical bowel obstruction or organic disorders of the large or small bowel.
- •7.Subjects willing not to significantly alter their lifestyle, exercise regimen or diet during the course of the study.
- •8.Subjects able and willing to give written informed consent.
- •9.Subjects able to comply with the requirements of the protocol.
排除标准
- •1.Females who are pregnant, breast feeding, planning a pregnancy, or females of childbearing potential unwilling to use adequate contraception during the course of the study.
- •2.Subject of any age with evidence of weight loss, anemia, or rectal bleeding AND without documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed during the 6 months prior to dosing.
- •3.Documented mechanical bowel obstruction (e.g., bowel obstruction due to tumor, hernia), megacolon/ megarectum, or diagnosis of pseudo-obstruction.
- •4.Known or suspected organic disorders of the large or small bowel (e.g., inflammatory bowel disease, ulcerative colitis, Crohnâ??s Disease) or constipation secondary to a documented cause (e.g., surgery, bowel resection).
- •5.History of bowel resection.
- •6.Hospitalized for any gastrointestinal or abdominal surgical procedure during the 3 months prior to dosing.
- •7.Clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or clinically significant laboratory abnormalities.
- •8.Subjects with clinically significant cancer within the last 5 years
- •9.Subjects with history of any medical/ surgical condition that might significantly interfere with the absorption, distribution, metabolism, or excretion of the study drug.
- •10.Use within 4 weeks prior to baseline of systemic antibiotic.
- •11.Use of any prescription and/ or OTC laxatives during the 48 hour period prior to the first dose of study medication.
- •12.Subjects with a history of hypersensitivity to the study drugs (lubiprostone) or to any of the components (as listed in Section 2.1).
- •13.Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day).
- •14.Subjects who have participated in any other trial involving other investigational products within the last 30 days prior to the first planned drug administration.
研究者
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