| CTRI Number |
CTRI/2010/091/000552 [Registered on: 11/06/2010] |
| Last Modified On: |
11/03/2013 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
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. |
|
Scientific Title of Study
|
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) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AM-PHN-001 |
Protocol Number |
| NCT01064024 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
- |
| Designation |
|
| Affiliation |
|
| Address |
-
-
Not Applicable
N/A
-
India |
| Phone |
- |
| Fax |
- |
| Email |
- |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nikunj Patel |
| Designation |
|
| Affiliation |
|
| Address |
Director, CRO, Amneal Pharmaceuticals Co (I) Pvt Ltd, &D Centre
882/1 Village Rajoda, Near Hotel Kankavati
Not Applicable
N/A
382220
India |
| Phone |
|
| Fax |
|
| Email |
nikunj@amneal.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Prayag Shah |
| Designation |
|
| Affiliation |
|
| Address |
Senior Manager, CRO, Amneal Pharmaceuticals Co(I) Pvt Ltd, R&D Centre
Near Hotel Kankavati
Not Applicable
N/A
382220
India |
| Phone |
+91-9723558031 |
| Fax |
|
| Email |
prayags@amnealindia.com |
|
|
Source of Monetary or Material Support
|
| Amneal Pharmaceuticals, LLC
85 Adams Avenue
Hauppauge, NY 11788
Tel: 631-952-0214
Fax: 631-656-1006 |
|
Primary Sponsor
Modification(s)
|
| Name |
Amneal Pharmaceuticals |
| Address |
LLC85 Adams Avenue
Hauppauge
NY 11788
Telephone 6319520214
Fax 6316561006 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sristek Consulting Pvt Ltd.
Plot No.33,Sai Enclave
Road No.12,Banjara Hills,Hyderabad-34 |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Konanki Venugopal |
Meenakshi Mission Hospital & Research Centre, Lake Area, Melur Road, Madurai 625107, Tamil Nadu |
Meenakhi Mission Hospital & Research Centre,Lake Area, Melur Road-625107
Madurai
TAMIL NADU |
+91-452-2588741
+91-452-2586353
konanki9@rediffmail.com |
| Dr. Chaitanya Shembekar |
OM Women's Hospital, Pushpkunj, Central Bazar Road, Ramadaspeth, Nagpur - 440010, Maharastra |
Om Women's Hospital,Pushpkunj, Central Bazar Road, Ramadaspeth-440010
Nagpur
MAHARASHTRA |
917122454687
chaitanyashembekar@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethical Review Board Meenakshi Mission Hospital and Research Centre Madurai |
Approved |
| Independent Ethics Committee, Nagpur |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Uncomplicated Urinary Tract Infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Phenazopyridine Hydrochloride Tablets USP 200mg |
every 8 hours for 48 hours |
| Comparator Agent |
Placebo Tablets |
every 8 hours for 48 hours |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 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 urination
2. Urgency of urination
3. Not being able to empty bladder completely/ passing only small amount of urine
4. Pain or uncomfortable pressure in lower abdomen or pelvic area caused by UTI
5. Low back pain caused by UTI
6. Blood in Urine
In addition overall rating will be assessed by the subjects |
At
Baseline visit
24 hours
48 hours |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/06/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |