NCT01064024已完成3 期
A Double Blind, Randomized, Parallel Controlled Study to Evaluate the Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg vs. Placebo as a Urinary Analgesic for Short Term Treatment in Female Subjects Suffering From Pain or Burning When Passing Urine Associated With Uncomplicated Urinary Tract Infections (uUTI)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 1
- 主要终点
- proportion of subjects in each treatment group who demonstrate reduction in pain or burning when passing urine.
研究概览
简要总结
This study will evaluate the safety and efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as a short term analgesic treatment for the primary symptoms of pain or burning when passing urine associated with uncomplicated urinary tract infections (uUTI)
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of uncomplicated urinary tract infection (uUTI)
- •Must have one of the following uUTI diagnosis
- •Urethritis
- •A Positive urine dipstick test showing nitrate or leukocyte esterase (LE)
- •Negative pregnancy test (if applicable)
- •Must have one or both of the following symptoms of
- •pain upon urination
- •burning upon urination
- •In addition, one of the following symptoms
- •Not being able to empty bladder completely
- •Pain or discomfort in lower abdomen, or pelvic areas
- •Frequent urge to urinate
- •Blood in urine
排除标准
- •Any diagnosis of a urinary tract or kidney disorder that is not a uUTI
- •A diagnosis of Pyelonephritis (kidney infections when lower uUTI spreads to the upper tract)
- •Women with a history of prior use of phenazopyridine hydrochloride
- •Women who have taken any systemic anti-infectives within seven days of study participation
- •Women with a history of G-6-PD deficiency or hemolytic anemia
- •Women who have a known history of anatomical genitourinary (GU) anomalies or GU surgery within the past 6 months
- •Women of child bearing age who do not consent to a pregnancy test
- •Women who are lactating
- •Chronic infection of the urinary tract requiring an intravenous pyelogram (IVP), ultrasound or cystoscopy
- •Subjects with clinically significant abnormal results or finding on the screening physical examination, laboratory tests, vital signs or ECG.
- •Subjects unable to comprehend the language of the informed consent and the self evaluation scales.
- •Subjects with serious acute illness (e.g. pneumonia) or an untreated or unstable medical illness that would likely interfere with assessments of uUTI
- •Subjects who have received an investigational medication as part of a drug trial 3 months prior to the baseline study visit
- •Subjects with a history of severe drug allergy or hypersensitivity
- •Subjects with a known sensitivity to Phenazopyridine, Hyoscyamine, Butabarbital and antibiotics.
- •Employees of the investigator or the institution who have direct involvement in the trial or other trials under the direction of the investigator or their associates.
研究组 & 干预措施
Phenazopyridine Hydrochloride Tablets, USP 200 mg
Active Comparator
干预措施: Phenazopyridine Hydrochloride (Drug)
Placebo
Placebo Comparator
Matching placebo to the phenazopyridine hydrochloride tablets
干预措施: Placebo (Drug)
结局指标
主要结局
proportion of subjects in each treatment group who demonstrate reduction in pain or burning when passing urine.
时间窗: 24 hrs after first dose and 48 hrs after second dose
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as an Analgesic for Short-Term Treatment in Female Subjects Suffering From Moderate-to-Severe Pain and Burning Upon Urination Associated With Uncomplicated Urinary Tract Infections (uUTI)Uncomplicated Urinary Tract InfectionsNCT01650051Amneal Pharmaceuticals, LLC424
Unknown
不适用
Bioequivalence of Phenazopyridine HCl in Healthy VolunteersHuman VolunteersNCT00743977Universal Enterprises24
已完成
3 期
Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisNCT00287716Genentech, Inc.435
已完成
2 期
Study to Explore the Effective Doses and to Assess the Safety and Efficacy of Hypidone Hydrochloride TabletsMajor Depressive DisorderNCT03739632Zhejiang Huahai Pharmaceutical Co., Ltd.240
已完成
1 期
A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Paliperidone Palmitate in Patients With SchizophreniaSchizophreniaNCT01559272Janssen Research & Development, LLC328