A double blind randomized single period parallel placebo controlled comparative efficacy study of Nitazoxanide 500 mg Tablets Test of Rising Pharmaceuticals Inc USA and Alinia Nitazoxanide Tablets Ref of Romark Pharmaceuticals USA in patients ≥12 years old with diarrhea caused by Giardia lamblia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 336
- 试验地点
- 19
- 主要终点
- The primary endpoint used to determine efficacy is the clinical response, resolution of clinical symptoms associated with giardiasis the proportion of patients with a well clinical response evaluated on Days 7 plus 1 and 9 plus 1 will be the endpoint compared between treatments
研究概览
简要总结
This was a double blind, randomized, single-period, parallel, placebo-controlled,
comparative efficacy study of Nitazoxanide 500 mg Tablets in patients suffering from
diarrhea caused by G. lamblia. A total of four visits to the Investigator site were scheduled: Screening Visit (Visit 1: Day -7 to Day -1); Randomization Visit (Visit 2: Day 0); and two Evaluation Visits (Visits 3 & 4: Day 7+1 & Day 9+1).Subjects received detailed instructions on the administration of study medication, and the medications that should be avoided during the study period. Subjects were required to receive the reference listed drug (RLD), the generic Nitazoxanide tablets 500 mg, or placebo twice daily for 3 days (i.e., on Study Days 1, 2 and 3) with food. Subjects returned to the Investigator sites for two evaluation visits (Visit 3: Day 7+1 &
Visit 4: Day 9+1), to submit their stool samples in the specified container. These stool
specimens were evaluated for cysts and trophozoites of G. lamblia. On Visit 4, subjects were asked to complete all other End of study procedures. Final
blood samples for safety analysis, general and systemic examination, vital signs
recording, review of clinical symptoms/medical history/concomitant medication and
adverse event recording was completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Infection with Giardia lamblia in immunocompetent male or female patients aged more than or equal to 12 years Patients with diarrhea more than or equal 3 unformed stools per day with one or more enteric symptoms such as abdominal pain or cramps nausea vomiting tenesmus or malabsorption Giardia lamblia cysts detected in a stool specimen obtained during screening Willing to give their patient or legal guardian written informed consent or written informed assent to participate in the study Patients should be stable on their disease for the participation in the study as per the Principal Investigators PI discretion.
排除标准
- •An additional intestinal pathogen that might contribute to the presenting symptoms eg pathogenic bacteria such as Salmonella Shigella Entamoeba histolytica Cryptosporidium parvum Administration of drugs known to affect intestinal motility or diarrhea within 7 days of enrollment Stool colony count of more than 10000 Colony forming units CFU per ml for diarrhea causing pathogens Use within 2 weeks of enrollment of any drug or therapy with antiprotozoal activity including 5 nitroimidazoles such as metronidazole tinidazole ornidazole secnidazole paromomycin nitazoxanide azithromycin hydroxyquinoline derivatives acetamide analogues such as diloxanide paromomycin and nitazoxanide Trimethoprim sulfamethoxazole may be used within 2 weeks of enrollment but may not be used concomitantly during therapy Patients known or suspected of having HIV/AIDS Patients with compromised renal or hepatic function Patients with chronic gastrointestinal illness such as IBS or IBD etc Patients with malnutrition defined as a BMI less than 18.5 kg per m2 in adults and BMI < 5% for age based on Centers for Disease Control and Prevention growth chart in adolescents ≥12 years of age Concomitant use of warfarin antimicrobial drugs and drugs with antiprotozoan activity other than the study drugs Females who are pregnant suspected of being pregnant or breast feeding urine pregnancy tests are required for all women of childbearing potential or who are two years or less post-menopausal Serious systemic disorders incompatible with the study as per PIs discretion History of hypersensitivity to Nitazoxanide or other sulphur containing drugs like penicillins sulphonamides etc Patients in whom the possibility of receiving a placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patients illness according to the Investigators judgment Patients with known immune deficiencies eg cancer chemotherapy patients patients with hypogammaglobulinemia.
结局指标
主要结局
The primary endpoint used to determine efficacy is the clinical response, resolution of clinical symptoms associated with giardiasis the proportion of patients with a well clinical response evaluated on Days 7 plus 1 and 9 plus 1 will be the endpoint compared between treatments
时间窗: Resolution of clinical symptoms associated with giardiasis the proportion of patients with a well clinical response evaluated on Days 7 plus 1 and 9 plus 1 will be the endpoint compared between treatments | A clinical response of well is defined as either | No symptoms no watery stool and no more than 2 soft stools with no hematochezia within the past 24 hours | No symptoms and no unformed stools within the past 48 hours
A clinical response of well is defined as either
时间窗: Resolution of clinical symptoms associated with giardiasis the proportion of patients with a well clinical response evaluated on Days 7 plus 1 and 9 plus 1 will be the endpoint compared between treatments | A clinical response of well is defined as either | No symptoms no watery stool and no more than 2 soft stools with no hematochezia within the past 24 hours | No symptoms and no unformed stools within the past 48 hours
No symptoms no watery stool and no more than 2 soft stools with no hematochezia within the past 24 hours
时间窗: Resolution of clinical symptoms associated with giardiasis the proportion of patients with a well clinical response evaluated on Days 7 plus 1 and 9 plus 1 will be the endpoint compared between treatments | A clinical response of well is defined as either | No symptoms no watery stool and no more than 2 soft stools with no hematochezia within the past 24 hours | No symptoms and no unformed stools within the past 48 hours
No symptoms and no unformed stools within the past 48 hours
时间窗: Resolution of clinical symptoms associated with giardiasis the proportion of patients with a well clinical response evaluated on Days 7 plus 1 and 9 plus 1 will be the endpoint compared between treatments | A clinical response of well is defined as either | No symptoms no watery stool and no more than 2 soft stools with no hematochezia within the past 24 hours | No symptoms and no unformed stools within the past 48 hours
次要结局
- A parasitological response is defined as no cysts or trophozoites in either of the two stool samples collected between 4 to 7 days after completion of therapy Visits 3 and 4 that is on Days 7 plus 1 and 9 plus 1(Nil)