FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/01/016862 [Registered on: 03/01/2019] Trial Registered Prospectively
Last Modified On: 21/01/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study the effectiveness of Nitazoxanide 500mg Tablets in adolescence and adults with Diarrhea in Giardiasis 
Scientific Title of Study   A double blind randomized single period parallel placebo controlled comparative efficacy study of Nitazoxanide 500 mg Tablets Test of Rising Pharmaceuticals Inc USA and Alinia Nitazoxanide Tablets Ref of Romark Pharmaceuticals USA in patients ≥12 years old with diarrhea caused by Giardia lamblia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CR180-17 Version 1 Amendment 02 Dated 12 December 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Subhra Lahiri  
Designation  Associate Vice President 
Affiliation  AXIS Clinicals Ltd  
Address  AXIS Clinicals Ltd 1 121 1 Miyapur Hyderabad 500049 Telangana INDIA
AXIS Clinicals Ltd 1 121 1 Miyapur Hyderabad 500049 Telangana INDIA
Hyderabad
TELANGANA
500049
India 
Phone  8886221089  
Fax  914040408060  
Email  Subhra.L@axisclinicals.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Subhra Lahiri  
Designation  Associate Vice President 
Affiliation  AXIS Clinicals Ltd  
Address  AXIS Clinicals Ltd 1 121 1 Miyapur Hyderabad 500049 Telangana INDIA
AXIS Clinicals Ltd 1 121 1 Miyapur Hyderabad 500049 Telangana INDIA
Hyderabad
TELANGANA
500049
India 
Phone  8886221089  
Fax  914040408060  
Email  Subhra.L@axisclinicals.com  
 
Details of Contact Person
Public Query  
Name  Dr Subhra Lahiri  
Designation  Associate Vice President 
Affiliation  AXIS Clinicals Ltd  
Address  AXIS Clinicals Ltd 1 121 1 Miyapur Hyderabad 500049 Telangana INDIA
AXIS Clinicals Ltd 1 121 1 Miyapur Hyderabad 500049 Telangana INDIA
Hyderabad
TELANGANA
500049
India 
Phone  8886221089  
Fax  914040408060  
Email  Subhra.L@axisclinicals.com  
 
Source of Monetary or Material Support  
Rising Pharmaceuticals Inc Park 80 West Plaza 1 250 Pehle Avenue Suite 601 Saddle Brook NJ 076633 
 
Primary Sponsor  
Name  Rising Pharmaceuticals Inc 
Address  Rising Pharmaceuticals Inc Park 80 West 250 Pehle Ave Saddle Brook NJ 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
AXIS Clinicals Ltd  1 121 1 Miyapur Hyderabad 500049 Andhra Pradesh INDIA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 19  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bharat Ratanlal Jain  ACE Hospital Research Centre  ACE Hospital S No 32/2A Erandwane Gulwani Maharaj Road pune
Pune
MAHARASHTRA 		 9860383386

dr_bharatjain@rediffmail.com 
Dr Chandra Shekar Gillurkar  Advanced Critical Care Gillurkar Multispecialty Hospital  Advanced Critical Care Gillurkar Multispeciality Hospital 20 Reshimbaugh Umred Road Sakkaradara Nagpur Maharashtra 440001
Nagpur
MAHARASHTRA 		 9890005678

cgillukar@yahoo.com 
Dr Shrikanth Vishnu Deshpande  Ashirwad Hospital and Research Centre  Ashirwad Hospital and Research Centre Maratha section Near Jijamata udyan Ulhasnagar 421004 Maharashtra India
Thane
MAHARASHTRA 		 9822017445

writetoshrikant@rediffmail.com 
Dr Prakash S Ramanagoudar  Dr S R Ramanagoudar MSH RI Pvt Ltd  Dr S R Ramanagoudar MSH RI Pvt Ltd Malapur Road Dharwad Karnataka
Dharwad
KARNATAKA 		 9480552756

drramanagoudarmsh@gmail.com 
Dr Hemant Ramsharan Gupta  Grant Govt Medical College Sir JJ Group of Hospita  Department of Medicine Grant Govt Medical College Sir JJ Group of Hospitals Byculla Mumbai 400008 Maharashtra Indi
Mumbai
MAHARASHTRA 		 9820095763

drhemantgupta@hotmail.com 
Dr Sanjay Raut  Indira Gandhi Govt Medical College Hospital  Indira Gandhi Govt Medical College Hospital Central Avenue Road Near Main Railway station Nagpur 440018 Maharashtra India
Nagpur
MAHARASHTRA 		 7741809728

sanjaykuber@hotmail.com 
Dr Vineet Sukla  KRM Hospital and Research Centre  KRM Hospital and Research Centre 3/92-93 vijayant khand Gomti nagar lucknow 226010 Uttar Pradesh India
Lucknow
UTTAR PRADESH 		 7007208089

krmhrclko@gmail.com 
Dr Sandeep Kumar Gupta  M V Hospital Research Centre   M V Hospital Research Centre 314 30 Mirza Mandi Chowk Lucknow 226003 Uttar Pradesh India
Lucknow
UTTAR PRADESH 		 9336077839

sandeepkumar.gupta@rediffmail.com 
Dr Gaurish G Gadbail  Nirmal Hospital Private Limited  Nirmal Hospital Private Limited Ring road Surat 395002 Gujarat India
Surat
GUJARAT 		 9727712032

gaurish.g@gmail.com 
Dr Pankaj Srivastava  Om surgical Centre and Maternity Home  Om surgical Centre and Maternity Home, SA 12 3 P4 Shri Krishna Nagar Colony Ashapur Varanasi Uttar Pradesh 221007
Varanasi
UTTAR PRADESH 		 9415228617

drpankajbns@gmail.com 
Dr Jitendra Singh Kushwaha  Parkhar Hospitals Pvt Ltd  Parkhar Hospitals Pvt Ltd 8/219 Arya Nagar Kanpur Uttar Pradesh 208002 India
Kanpur Dehat
UTTAR PRADESH 		 9415040752

Pi.clintrial@gmail.com 
Dr Monica Gupta  Samvedna Hospital  Samvedna Hospital B27/889 Ravindrapuri Varanasi 221005, Uttar Pradesh India
Varanasi
UTTAR PRADESH 		 9918429594

monicag4@yahoo.com 
Dr Tapan Shah  Sangini Hospital  Sangini Hospital 1st floor ssantorini Square b h Abhishree Complex Satelite Ahmedabad Gujarat
Ahmadabad
GUJARAT 		 9825739241

drtapanshah@gmail.com 
Dr Piyali Bhattacharya   Sanjay Gandhi Post Graduate Institute of Medical sciences  Sanjay Gandhi Post Graduate Institute of Medical sciences Raebareli Road Lucknow 226014
Lucknow
UTTAR PRADESH 		 9415104073

drpiyali@gmail.com 
Dr Prakash H Kurmi  Shivam Hospital  Shivam Hospital C4 Satyanarayan society Gors kuva Jashoda nagar char rasta maninagar Ahmedabad 380008 Gujarat India
Ahmadabad
GUJARAT 		 9825047692

dr_prakashkurmi@yahoo.co.in 
Dr Keyur Madan Brahme  SSG Hospital and Medical College  Department of Medicine Medical College SSG Hospital Anandpura Vadodara 39001 Gujarat India
Vadodara
GUJARAT 		 9987439363

keyurbrahme@gmail.com 
Dr Arti Muley  Sumandeep Vidyapeeth Dhiraj General Hospital  Sumandeep Vidyapeeth Dhiraj General Hospital At PO Piparia Waghodia Vadodara Gujarat India 391760
Vadodara
GUJARAT 		 9879609196

muleyarti40@gmail.com 
Dr Krishna Madhukar Giri  Supe Heart and Diabetes Hospital and Research Centre  Supe Heart and Diabetes Hospital and Research Centre, Opp Aadharashram Gharpuri ghat Near Rungtha High school Ashok stambh Nashik 422002 Maharashtra India
Nashik
MAHARASHTRA 		 9975753763

drkmgiri@gmail.com 
Dr Bachu Aruna  Vijaya Super Specialty Hospital  Vijaya Super Specialty Hospital S2 cine complex road pogathota Nellore 524001 Andhra pradesh India
Nellore
ANDHRA PRADESH 		 8612321828

projectspcr@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 15  
Name of Committee  Approval Status 
Ashirwad Ethics Committee  Approved 
Ethics committee Dr S R Ramanagoudar MSH RI Pvt Ltd  Approved 
Ethics Committee Parkhar Hospital Pvt Ltd  Approved 
Institutional Ethics committee Amai Charitable trusts ACE Hospital  Approved 
Institutional Ethics committee for Human Research Medical Collage SSG Hospital  Approved 
Institutional Ethics committee for MV Hospital research Centre  Approved 
Institutional Ethics committee Grant Govt Medical College Sir JJ Group of Hospitals  Approved 
Institutional Ethics committee Om surgical Centre and Maternity Home  Approved 
Jasleen Hospitals Ethics Committee  Approved 
KRM Hospital Ethics Committee  Approved 
Nirmal Hospital Private Limited Ethics Committee  Approved 
Samvedna Hospital Ethics Committee  Approved 
Sangini Hospital Ethics committee  Approved 
Supe Hospital Ethics Committee  Approved 
VijayaEthicsCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A071||Giardiasis [lambliasis],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Alinia® Nitazoxanide 500 mg Tablets Reference  The study will consist of multicentric and eligible Subjects as per randomization are required to receive the generic Alinia® Nitazoxanide 500 mg Tablets, twice daily for 3 days that is on Study Days 1 2 and 3 with food 
Intervention  Nitazoxanide 500 mg Tablets and Placebo  The study will consist of multicentric and eligible Subjects as per randomization are required to receive the generic Nitazoxanide tablets 500 mg, twice daily for 3 days that is on Study Days 1 2 and 3 with food 
Comparator Agent  Placebo  The study will consist of multicentric and eligible Subjects as per randomization are required to receive the Placebo twice daily for 3 days that is on Study Days 1 2 and 3 with food 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Infection with Giardia lamblia in immunocompetent male or female patients aged more than or equal to 12 years
Patients with diarrhea more than or equal 3 unformed stools per day with one or more enteric symptoms such as abdominal pain or cramps nausea vomiting tenesmus or malabsorption
Giardia lamblia cysts detected in a stool specimen obtained during screening
Willing to give their patient or legal guardian written informed consent or written informed assent to participate in the study
Patients should be stable on their disease for the participation in the study as per the Principal Investigators PI discretion 
 
ExclusionCriteria 
Details  An additional intestinal pathogen that might contribute to the presenting symptoms eg pathogenic bacteria such as Salmonella Shigella Entamoeba histolytica Cryptosporidium parvum
Administration of drugs known to affect intestinal motility or diarrhea within 7 days of enrollment
Stool colony count of more than 10000 Colony forming units CFU per ml for diarrhea causing pathogens
Use within 2 weeks of enrollment of any drug or therapy with antiprotozoal activity including 5 nitroimidazoles such as metronidazole tinidazole ornidazole secnidazole paromomycin nitazoxanide azithromycin hydroxyquinoline derivatives acetamide analogues such as diloxanide paromomycin and nitazoxanide Trimethoprim sulfamethoxazole may be used within 2 weeks of enrollment but may not be used concomitantly during therapy
Patients known or suspected of having HIV/AIDS
Patients with compromised renal or hepatic function
Patients with chronic gastrointestinal illness such as IBS or IBD etc
Patients with malnutrition defined as a BMI less than 18.5 kg per m2 in adults and BMI < 5% for age based on Centers for Disease Control and Prevention growth chart in adolescents ≥12 years of age
Concomitant use of warfarin antimicrobial drugs and drugs with antiprotozoan activity other than the study drugs
Females who are pregnant suspected of being pregnant or breast feeding urine pregnancy tests are required for all women of childbearing potential or who are two years or less post-menopausal
Serious systemic disorders incompatible with the study as per PIs discretion
History of hypersensitivity to Nitazoxanide or other sulphur containing drugs like penicillins sulphonamides etc
Patients in whom the possibility of receiving a placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patients illness according to the Investigators judgment
Patients with known immune deficiencies eg cancer chemotherapy patients patients with hypogammaglobulinemia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking
Modification(s)  		 Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary endpoint used to determine efficacy is the clinical response, resolution of clinical symptoms associated with giardiasis the proportion of patients with a well clinical response evaluated on Days 7 plus 1 and 9 plus 1 will be the endpoint compared between treatments
A clinical response of well is defined as either
No symptoms no watery stool and no more than 2 soft stools with no hematochezia within the past 24 hours
No symptoms and no unformed stools within the past 48 hours 		 Resolution of clinical symptoms associated with giardiasis the proportion of patients with a well clinical response evaluated on Days 7 plus 1 and 9 plus 1 will be the endpoint compared between treatments
A clinical response of well is defined as either
No symptoms no watery stool and no more than 2 soft stools with no hematochezia within the past 24 hours
No symptoms and no unformed stools within the past 48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
A parasitological response is defined as no cysts or trophozoites in either of the two stool samples collected between 4 to 7 days after completion of therapy Visits 3 and 4 that is on Days 7 plus 1 and 9 plus 1  Nil 
 
Target Sample Size   Total Sample Size="336"
Sample Size from India="336" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="320" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 05/02/2019 
Date of Study Completion (India) 08/06/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  
This was a double blind, randomized, single-period, parallel, placebo-controlled,
comparative efficacy study of Nitazoxanide 500 mg Tablets in patients suffering from
diarrhea caused by G. lamblia. A total of four visits to the Investigator site were scheduled: Screening Visit (Visit 1: Day -7 to Day -1); Randomization Visit (Visit 2: Day 0); and two Evaluation Visits (Visits 3 & 4: Day 7+1 & Day 9+1).Subjects received detailed instructions on the administration of study medication, and the medications that should be avoided during the study period. Subjects were required to receive the reference listed drug (RLD), the generic Nitazoxanide tablets 500 mg, or placebo twice daily for 3 days (i.e., on Study Days 1, 2 and 3) with food. Subjects returned to the Investigator sites for two evaluation visits (Visit 3: Day 7+1 &
Visit 4: Day 9+1), to submit their stool samples in the specified container. These stool
specimens were evaluated for cysts and trophozoites of G. lamblia. On Visit 4, subjects were asked to complete all other End of study procedures. Final
blood samples for safety analysis, general and systemic examination, vital signs
recording, review of clinical symptoms/medical history/concomitant medication and
adverse event recording was completed. 
 
Close