A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 557
- 试验地点
- 3
- 主要终点
- Change from baseline of the Lactose Intolerance (LI) symptom composite score compared to placebo
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States (US) to assess the efficacy of RP-G28 compared to placebo on symptom reduction related to lactose intolerance.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18-75 years of age, inclusive, at screening;
- •Intolerance to milk and other dairy products;
- •Patient agrees to refrain from all other treatments and products used for lactose intolerance, to follow diet modifications required during periods of the study that include abstinence from all dairy in some periods and consuming dairy in other periods;
- •Patient meets the defined minimum lactose intolerance symptom composite score; and
- •Patient has positive Hydrogen Breath Test (HBT) results for lactase deficiency.
排除标准
- •Patient has a disorder associated with abnormal gastrointestinal motility such as gastroparesis (from any cause), amyloidosis, neuromuscular diseases (including Parkinson's disease), collagen vascular diseases, uremia, or malnutrition;
- •Patient has undergone bowel preparation for endoscopic or radiologic investigation within 4 weeks of Screening (example, colonoscopy preparation);
- •Patient has a history of surgery that alters the normal function of the gastrointestinal tract including, but not limited to: fundoplication, gastrointestinal bypass surgery, bariatric surgery, gastric banding, colostomy, vagotomy, pyloroplasty, colectomy or other surgery for Crohn's disease or ulcerative colitis; and
- •Patient has received antibiotic treatment, or had a high colonic enema, colonic irrigation, colonic hydrotherapy, or colonic cleaning within 30 days prior to or during Screening.
研究组 & 干预措施
RP-G28
galacto-oligosaccharide, spray-dried powder for reconstitution for oral administration, 7.5 grams 2 times per day
干预措施: RP-G28 (Drug)
Placebos
maltodextrin, powder for reconstitution for oral administration, 7.5 grams 2 times per day
干预措施: Placebos (Drug)
结局指标
主要结局
Change from baseline of the Lactose Intolerance (LI) symptom composite score compared to placebo
时间窗: Day 61
Change from baseline of the LI symptom composite score compared to placebo. The LI symptom composite score includes abdominal pain, abdominal bloating, abdominal cramping, and abdominal gas.
次要结局
- Proportion of patients with a meaningful reduction in LI composite score.(Day 61)