A Prospective, Randomized, Double blind, Placebo Controlled, Two-arm, Comparative, Multicentric, Phase 2 Clinical Study to Evaluate the Efficacy & Safety of HDCD-092330 in Adults with Cystitis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- • Improvement in microbiological response-Percentage of subjects with non-significant bacteriuria (less than103cfu/ml)
研究概览
简要总结
Participants will be examined for eligibility during the screening period after signing the informed consent form (within 10 days prior to Baseline). An adequate number of participants with cystitis/uncomplicated UTI will be screened to enroll 120 participants, to have at least 100 evaluable participants.
Participants will be enrolled based on study eligibility criteria (inclusion and exclusion criteria). After signing the informed consent form, eligible participants will be randomized as per randomization, schedule either into active or in the placebo arm. All the participants will be given IP (active or placebo) on the same day. The date of first IP administration will be considered as Day1 and instructions about the dosage and timings will be given by Investigator as described in dosage & administration section. Non-responders or subjects not showing any improvement will be evaluated based on laboratory report and symptoms based on investigator’s discretion on visit 3 day 14 .
Core Endpoints
Improvement in microbiological response-Percentage of subjects with non-significant bacteriuria less than 10,000 cfu/ml
Improvement in clinical response -Reduction in overall symptoms of cystitis by using Symptomatic Assessment
There will be a total of 4 study visits for each participant.
Visit 1: Screening (-10 days to Day 0)
Visit 2: Baseline/ Day 1
Visit 3: Day 14 ± 3 days
Visit 4: Day 28 ± 3 days/ EOS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult female & male between18 to 60 years.
- •A.With at least two of the following mild to moderate signs or symptoms of Dysuria/Burning micturition, Increased Urinary frequency, Urinary urgency, Suprapubic pain B.
- •Along with Bacteriuria greater than 10,000 CFU/ml.
- •Male subjects with signs & symptoms of cystitis which do not require antibiotic therapy
- •Can signed informed consent and willing to participate and follow the study procedures
- •No concomitant participation in any other clinical trial since last 3 months
- •Women of child-bearing potential must agree to use adequate contraception during study period.
排除标准
- •Subjects with clinically significant cardiovascular, respiratory, cerebrovascular, hepatic, congenital, immunological or any other disorder as assessed by medical history
- •Subjects with signs or symptoms of fever greater than 102 degree fahrenheit, shaking chills, or other clinical manifestations suggestive of Complicated Cystitis as per Investigator discretion.
- •Subjects who are undergoing treatment with Antibiotics for the same or any other reason or within last 1 month.
- •Subjects taking dietary, herbal supplements or any other medication within last 10 days for the treatment of cystitis .
- •Subjects with history of neurogenic bladder, concomitant urogenital infection such as urethritis, vaginitis (for females), pyelonephritis, benign or malignant tumors or any other pre-existing systemic diseases (auto immune disorders, hormonal replacement, etc.) necessitating long-term medications
- •Male subjects with severe complicated cystitis secondary to prostatitis, epididymitis, benign prostatic hyperplasia, urolithiasis along with systemic symptoms requiring antibiotics, hospitalization or other surgical treatments for comorbidities.
- •Subjects diagnosed with renal insufficiency (renal failure, bilateral obstruction, or solitary kidney), Arterial aneurysm in vicinity of stones, Anatomical obstruction distal to stone, Kidney tumors, chronic kidney disease, sepsis, chronic infection or any other renal disease
- •Subjects with Uncontrolled Diabetes with HbA1c values greater than 9% in last 3 months.
- •Pregnant and lactating women.
- •Any other conditions physical, psychological, or social that can interfere with the subject’s compliance to the study in the opinion of the Investigator.
- •Subjects with known history of allergy to the study drug or any of its ingredients.
- •Known case of alcohol or any other substance abuse.
结局指标
主要结局
• Improvement in microbiological response-Percentage of subjects with non-significant bacteriuria (less than103cfu/ml)
时间窗: Visit 1: Screening (-10days to Day 0) | Visit 2: Baseline/ Day 1 | Visit 3: Day 14 ± 3 days | Visit 4: Day 28 ± 3 days
• Improvement in clinical response -Reduction in overall symptoms of cystitis
时间窗: Visit 1: Screening (-10days to Day 0) | Visit 2: Baseline/ Day 1 | Visit 3: Day 14 ± 3 days | Visit 4: Day 28 ± 3 days
次要结局
未报告次要终点
研究者
Dr Ankita Somani
Altiuz Multispeciality Hospital and Research Centre