CTRI/2010/091/000552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)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion Criteria:
- •1. Females, 18 years of age or older
- •2. Able to give written informed consent
- •3 Diagnosis of uncomplicated urinary tract infection
- •4. Must have one of the following uUTI diagnosis - Cystitis or Urethritis
- •5. A positive urine dipstick showing nitrate or leukocyte esterase (LE)
- •6. Negative Urine Pregnancy Test (if applicable)
- •7. Must have one or both of the following symptom of - pain upon urination, burning upon urination
- •8. In addition, any one of the following symptoms that subject reports
- •a) Not being able to empty bladder completely
- •b) Pain or discomfort in lower abdomen, or pelvic areas caused by UTI
- •c) Frequent urge to urinate
- •d) Blood in urine
- •e) Low back pain caused by your urinary tract infection
排除标准
- •Exclusion Criteria:
- •1. Any diagnosis of a urinary tract or kidney disorder that is not a uUTI
- •2. A diagnosis of Pyelonephritis (kidney infections when lower uUTI spreads to the upper tract)
- •3. Women with a history of prior use of phenazopyridine hydrochloride
- •4. Women who have taken any systemic anti-infectives within seven days of study participation.
- •5. Women with a history of G-6-PD deficiency or hemolytic anemia
- •6. Women who have a known history of anatomical genitourinary (GU) anomalies or GU surgery within the past 6 months
- •7. Women of child bearing age who do not consent to a pregnancy test
- •8. Women who are lactating
- •9. Chronic infection of the urinary tract requiring an intravenous pyelogram (IVP), ultrasound or cystoscopy
- •10. Subjects with clinically significant abnormal results or finding on the screening physcal examination, laboratory tests, vital signs or ECG
- •11. Subjects unabele to comprehend the language of the informed consent and the self evaluation scales
- •12. Subject with serious acute illness (e.g. pneumonia) or an untreated or unstable medical illness that would likely interfere with assessments of uUTI
- •13. Subjects who have received an investigational medication as a part of a drug trial 3 months prior to the baseline study visit
- •14. Subjects with a history of severe drug allergy or hypersensitivity
- •15. Subjects with a known sensitivity to Phenazopyridine, Hyoscyamine, Butabarbital and antibiotics
- •16. Employees of the investigator or institution who have direct involvement in the trial or other trials under the direction of the investigator or their associates
研究者
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