To evaluate the safety and efficacy of Phenazopyridine HCl Tablets, USP 200 mg as a short term analgesic treatment of pain or burning when passing urine associated with uUTI.

Phase 3

• Conditions: Uncomplicated Urinary Tract Infection

• Registration Number: CTRI/2010/091/000552
• Lead Sponsor: Amneal Pharmaceuticals

Brief Summary

This study is a double-blind, randomized, parallel controlled study to evaluate the safety and efficacy of Phenazopyridine Hydrochloride Tablets, USP 200mg vs placebo as a Urinary Analgesic for a short term treatment in female subjects suffering from pain or burning when passing urine associated with uncomplicated urinary tract infections. This trial will be conducted in two centres in India and four centres in United States of America. The primary efficacy variable will be the proportion of subjects in each treatment group who demonstrate reduction in pain or burning when passing urine. And additional evaluation and assessments will be based on the changes from the baseline for the subject's self evaluation of symptoms associated with uUTI, which are listed in Urinary Tract Infection Symptom Assessment questionnaire This is a global clinical trial, planned to randomize 200 subjects globally and the study start date in USA is Dec 2009. As of May 2010, a total of 80 subjects have been randomized for this trial. In India, expected to randomize 100 subjects and the date of enrollment is from 14 Jun 2010.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• 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.

Exclusion Criteria

• Exclusion Criteria: 1.
• Any diagnosis of a urinary tract or kidney disorder that is not a uUTI2.
• A diagnosis of Pyelonephritis (kidney infections when lower uUTI spreads to the upper tract)3.
• Women with a history of prior use of phenazopyridine hydrochloride4.
• 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 anemia6.
• Women who have a known history of anatomical genitourinary (GU) anomalies or GU surgery within the past 6 months7.
• Women of child bearing age who do not consent to a pregnancy test8.
• Women who are lactating9.
• Chronic infection of the urinary tract requiring an intravenous pyelogram (IVP), ultrasound or cystoscopy10.
• Subjects with clinically significant abnormal results or finding on the screening physcal examination, laboratory tests, vital signs or ECG11.
• Subjects unabele to comprehend the language of the informed consent and the self evaluation scales12.
• Subject with serious acute illness (e.g. pneumonia) or an untreated or unstable medical illness that would likely interfere with assessments of uUTI13.
• Subjects who have received an investigational medication as a part of a drug trial 3 months prior to the baseline study visit14.
• Subjects with a history of severe drug allergy or hypersensitivity15.
• Subjects with a known sensitivity to Phenazopyridine, Hyoscyamine, Butabarbital and antibiotics16.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Efficacy will be based on Subject's self evaluation of the symptom of pain or burning when passing urine	Relief of pain or burning when passing urine will be compared from baseline to 24 hours and 48 hours of treatment

Secondary Outcome Measures

Name	Time	Method
Evaluation and Assessment of uncomplicated Urinary Tract Infection will be based on the subject's evaluation on one or more of the following: 1. Frequency of urination2. Urgency of urination3. Not being able to empty bladder completely/ passing only small amount of urine4. Pain or uncomfortable pressure in lower abdomen or pelvic area caused by UTI5. Low back pain caused by UTI6. Blood in UrineIn addition overall rating will be assessed by the subjects	At Baseline visit24 hours48 hours

Trial Locations

Locations (2)

Meenakshi Mission Hospital & Research Centre, Lake Area, Melur Road, Madurai 625107, Tamil Nadu; 🇮🇳 Madurai, TAMIL NADU, India

OM Women's Hospital, Pushpkunj, Central Bazar Road, Ramadaspeth, Nagpur - 440010, Maharastra; 🇮🇳 Nagpur, MAHARASHTRA, India

Meenakshi Mission Hospital & Research Centre, Lake Area, Melur Road, Madurai 625107, Tamil Nadu

🇮🇳Madurai, TAMIL NADU, India

Dr. Konanki Venugopal

Principal investigator

konanki9@rediffmail.com