CTRI/2022/06/043433已完成不适用
A Multi-Center, Double-Blind, Randomized, Three-arm, Placebo–Controlled, Single Period, Parallel-Group, Clinical Endpoint Bioequivalence Study of Nitazoxanide Tablets 500 mg of Annora Pharma Private Limited, India and ALINIA® (Nitazoxanide) Tablets 500 mg of Romark, L.C., USA in Patients with Diarrhea Caused by Giardia Lamblia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 17
- 主要终点
- The proportion of patients with a well clinical response evaluated on (Day 9±1) compared between treatments.
研究概览
简要总结
Thisis A Multi-Center, Double- Blind, Randomized, Three-arm, Placebo Controlled,Single Period, Parallel-Group, and Clinical Endpoint Bioequivalence Study. Inthis study as per the routine clinical practice patients will be attending thescheduled visits. So there will be total 3 visits, Visit 1: Screening (Day-7 toDay-0), Visit 2: Randomization ( Day 0), Visit 3: Efficacy/End of the studyEvaluation (Day 9±1) Visit 1 and 2 can beperformed on the same day if feasible. Apart from the scheduled visits, thepatient can visit clinical site on any day. This will be termed as unscheduledvisit. Thisstudy will be managed by Raptim Research Pvt Ltd.
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
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Infection with Giardia lamblia in immunocompetent male or female patients aged ≥12 years with the following criteria a.
- •diarrhea (defined as the passage of three or more unformed stools per day) and b.
- •a positive stool specimen with cysts of Giardia lamblia as the sole identifiable Pathogen on the day of enrollment.
- •Willing to provide written informed consent‡ for participation in the study and having ability to comprehend the nature and purpose of the study.
- •In case of patients with age <18 years, legally acceptable representatives (LAR; e.g.parent/guardian/care-taker) must provide consent and Written Assent will be taken from Patients if they are able to comprehend the nature of the study.
- •Patients with diarrhea (≥ 3 unformed stools/day) with at least one enteric symptom.
- •Patients should be stable on their disease for the participation in the study as per the Principal Investigators (PI) discretion
- •Agree to comply with the visit schedule and other study requirements.
- •In case of male patients: -Patients either abstain from sexual intercourse or who are willing to use adequate contraception (e.g. use of condoms with or without spermicide) during sexual intercourse with female partners of child bearing potential from screening day till 7 days after last dose of the study.
- •In case of female patients: -Negative urine pregnancy test NOTE: urine pregnancy tests are required for all women of childbearing potential or who are two years or less post-menopausal -Female patients with child bearing potential or those within their first two years after onset of menopause must be willing to either abstain from sexual intercourse, or use of acceptable birth control methods from screening day until 7 days after last dose of the study [Acceptable birth control methods include barrier methods such as diaphragm/condom with or without spermicide or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed.
排除标准
- •1.An additional intestinal pathogen that might contribute to the presenting symptoms (e.g. pathogenic bacteria such as Salmonella, Shigella, Entamoeba histolytica, Cryptosporidium parvum).
- •Administration of drug(s) known to affect intestinal motility or diarrhea within 7 days of enrollment.
- •Use of any drug or therapy with antiprotozoal activity including 5-nitroimidazoles such as metronidazole, tinidazole, ornidazole, secnidazole, paromomycin, nitazoxanide, azithromycin, hydroxyquinoline derivatives trimethoprim-sulfamethoxazole and acetamide analogues such as diloxanide within 2 weeks of enrollment.
- •Females who are pregnant or breast-feeding.
- •Patients known or suspected of having Human Immuno Deficiency Virus (HIV)/Acquired Immuno Deficiency Syndrome (AIDS).
- •Patients with compromised renal or hepatic function.
- •Patients with chronic gastrointestinal illness such as Irritable Bowel Syndrome(IBS)/Inflammatory Bowel Disease (IBD) etc.
- •Patients with malnutrition, defined as a body mass index (BMI) less than 18.5 kg/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 drug(s), anti-diarrheal drug(s) and drug(s)with anti-protozoan activity other than the study drugs.
- •Serious systemic disorders incompatible with the study.
- •History of hypersensitivity to Nitazoxanide or any other ingredient in the formulation.
- •Patients with known immune deficiencies (e.g., cancer patients on chemotherapy, Patients on oral or systemic steroid therapy, patients with hypogammaglobulinemia).
- •Patient who, in the opinion of the Investigator, would be non-compliant with the requirements of the study protocol.
结局指标
主要结局
The proportion of patients with a well clinical response evaluated on (Day 9±1) compared between treatments.
时间窗: Day 9±1
次要结局
- The success proportion for each active treatment compared with placebo, evaluated on (Day 9±1)(Day 9±1)
研究者
研究点 (17)
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