Clinical Bioequivalence Study of Nitazoxanide Tablets for patients with Diarrhea caused by Giardia Lamblia.
Scientific Title of Study
A Multi-Center, Double-Blind, Randomized, Three-arm, Placebo–Controlled, Single Period, Parallel-Group, Clinical Endpoint Bioequivalence Study of Nitazoxanide Tablets 500 mg of Annora Pharma Private Limited, India and ALINIA® (Nitazoxanide) Tablets 500 mg of Romark, L.C., USA in Patients with Diarrhea Caused by Giardia Lamblia.
Trial Acronym
NA
Secondary IDs if Any
Secondary ID
Identifier
CT/21/001 Version 01 Date 28/12/21
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dinesh Kumar Garg
Designation
Head – Clinical Trials
Affiliation
Raptim Research Pvt. Ltd.
Address
Raptim Research Pvt. Ltd.
A-226, PAP-213 Clinical Unit
A-242 Bioanalytical and Biostatistical Unit
T.T.C., Industrial Area, Mahape M.I.D.C. Thane MAHARASHTRA 400710 India
Phone
912227781889
Fax
Email
dinesh.garg@raptimresearch.com
Details of Contact Person Scientific Query
Name
Dr Chirag Shah
Designation
Head- Clinical Operations
Affiliation
Raptim Research Pvt. Ltd.
Address
Raptim Research Pvt. Ltd.
A-226, PAP-213 Clinical Unit A-242 Bioanalytical and Biostatistical Unit
T.T.C., Industrial Area, Mahape M.I.D.C. Thane MAHARASHTRA 400710 India
Phone
912227781889
Fax
Email
chirag.shah@raptimresearch.com
Details of Contact Person Public Query
Name
Dinesh Kumar Garg
Designation
Head – Clinical Trials
Affiliation
Raptim Research private Ltd
Address
A-242,A-226, TTC Industrial Area,
Near Mahape Depot,Mahape MIDC, Navi Mumbai - 400710 Thane MAHARASHTRA 400710 India
Phone
912227781887
Fax
Email
dinesh.garg@raptimresearch.com
Source of Monetary or Material Support
Mr. K. Ranjinth Kumar
Annora Pharma Private Limited,
Sy. No. 261, Annaram Village,
Gummadidala Mandal,
Sangareddy District-502313,
Telangana, India
Primary Sponsor
Name
Annora Pharma Private Limited
Address
Sy. No. 261, Annaram Village,
Gummadidala Mandal,
Sangareddy District 502313,
Telangana, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Raptim Research private Ltd
A-242,A-226, TTC Industrial Area,
Near Mahape Depot,Mahape MIDC, Navi Mumbai - 400710
Thane
MAHARASHTRA
400710
India
Clinical Research Room, Rajendra Prasad Ward King George Hospital
Clinical Research Room, Rajendra Prasad Ward King George Hospital Maharanipeta, Vishakapatnam 530002 AndraPradesh, India Visakhapatnam ANDHRA PRADESH
8106637595
drysundarrajuresearch@gmail.com
Dr Vinayak Sawardekar
Department of Medicine Grant Govt Medical College Sir JJ Group of Hospitals
Department of Medicine Grant Govt Medical College Sir JJ Group of Hospitals Byculla Mumbai 400008 Maharashtra India Mumbai MAHARASHTRA
9428942196
vinayaks1812@gmail.com
Dr K Sudheer
Great Eastern Medical School and Hospital.
Room No 2. 1st Floor Research Department, Ragolu, Srikakulam 532484, India. Srikakulam ANDHRA PRADESH
918106637595
drksudheerresearch@gmail.com
Dr Gouranga Sarkar
Health Point Hospital
Health Point Hospital , Prannath Pandit St, Lansdown , Padapukar Bhowanipore, 700025, India Kolkata WEST BENGAL
919830165760
dr.gourangasarkar@gmail.com
Dr Shyam Mukundan
Lakshmi Nursing Home
Lakshmi Nursing Home
Palace Road, Aluva,
683101, India
Ernakulam KERALA
919895714189
drshyammukundan@gmail.com
Dr Sudhir Pawar
Lokmanya Tilak Municipal Medical College & General Hospital,
Room no. 2, 2nd Floor, College Building, Department of Pharmacology, Sion, 400 022, India Mumbai MAHARASHTRA
9869111630
drsudhirpawar@gmail.com
Dr Parth Patel
Navneet Sushrusha Memorial Hospital, Ahmedabad
Navneet Sushrusha Memorial Hospital, Opp to Sarad patel Seva Samaj Hall in the lane opp to tele Exchange Navrangpura. Ahmedabad, Gujarat, India Ahmadabad GUJARAT
8511153020
drParthpatel445@gmail.com
Dr Pankaj Srivastava
Om Surgical Center & Maternity Home
SA-17/3, P-4, Sri Krishna Nagar, Pabaria, Ghazipur Road, 22 1007, India Varanasi UTTAR PRADESH
9125679989
drpankajbns@gmail.com
Dr V K Goyal
Panchsheel Hospital, Pvt Ltd
C-3, 63-A 64-A Yamuna Vihar, Delhi 110053 North East DELHI
9810106800
vkgoyal22@gmail.com
Dr Soni Jay Janakkumar
Parth Orthopaedic and surgical Hospital
Parth Orthopaedicand surgicalHospital, GalaxyArcad, Near GalaxyCinema Naroda,320008, India Ahmadabad GUJARAT
919898003433
drjaysoni.cr@gmail.com
Dr Vinay Kumar
Post Graduate department of Medicine GSVM Medical College
Post Graduatedepartment ofMedicine GSVMMedical College,swaroop Nagar, India Kanpur Dehat UTTAR PRADESH
918400331045
dr.vinaysachan@gmail.com
Dr Yogesh Sharma
Rajiv Gandhi Medical College & Chattrapati Shivaji Maharaj Hospital.
Department of Medicine Rajiv Gandhi Medical College & Chhatrapati shivaji Maharaj hospital & thane municipal corporation, Kalwa- 400605 India Thane MAHARASHTRA
919820192129
dr.yogeshsharmamd@yahoo.com
Dr Vijaykumar Barge
RCSM Government Medical College & CPR Hospital,
Dasara Chowk,
Bhausingji road, Town Hall, 41 6012, India.
Kolhapur MAHARASHTRA
Dose 500 mg Frequency Twice daily (Morning and Evening) Route of Administration Oral use Total duration of such intervention 3 days.
Intervention
Nitazoxanide 500 mg tables
Dose 500 mg
Frequency Twice daily (Morning and Evening)
Route of Administration Oral use Total duration of such intervention 3 days.
Inclusion Criteria
Age From
12.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Infection with Giardia lamblia in immunocompetent male or female patients aged ≥12 years with the following criteria
a. diarrhea (defined as the passage of three or more unformed stools per day) and
b. a positive stool specimen with cysts of Giardia lamblia as the sole identifiable
Pathogen on the day of enrollment.
2. Willing to provide written informed consent‡ for participation in the study and having
ability to comprehend the nature and purpose of the study.
-In case of patients with age <18 years, legally acceptable representatives (LAR; e.g.parent/guardian/care-taker) must provide consent and Written Assent will be taken from Patients if they are able to comprehend the nature of the study.
3. Patients with diarrhea (≥ 3 unformed stools/day) with at least one enteric symptom.
4. Patients should be stable on their disease for the participation in the study as per the Principal Investigators (PI) discretion
5. Agree to comply with the visit schedule and other study requirements.
6. In case of male patients:
-Patients either abstain from sexual intercourse or who are willing to use adequate
contraception (e.g. use of condoms with or without spermicide) during sexual intercourse with female partners of child bearing potential from screening day till 7 days after last dose of the study.
7. In case of female patients:
-Negative urine pregnancy test
NOTE: urine pregnancy tests are required for all women of childbearing
potential or who are two years or less post-menopausal
-Female patients with child bearing potential or those within their first two years after onset of menopause must be willing to either abstain from sexual intercourse, or use of acceptable birth control methods from screening day until 7 days after last dose of the study [Acceptable birth control methods include barrier methods such as diaphragm/condom with or without spermicide or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed.
ExclusionCriteria
Details
1.An additional intestinal pathogen that might contribute to the presenting symptoms (e.g. pathogenic bacteria such as Salmonella, Shigella, Entamoeba histolytica,
Cryptosporidium parvum).
2. Administration of drug(s) known to affect intestinal motility or diarrhea within 7 days of enrollment.
3. Use of any drug or therapy with antiprotozoal activity including 5-nitroimidazoles such as metronidazole, tinidazole, ornidazole, secnidazole, paromomycin,
nitazoxanide, azithromycin, hydroxyquinoline derivatives
trimethoprim-sulfamethoxazole and acetamide analogues such as diloxanide within 2 weeks of enrollment.
4. Females who are pregnant or breast-feeding.
5. Patients known or suspected of having Human Immuno Deficiency Virus (HIV)/Acquired Immuno Deficiency Syndrome (AIDS).
6. Patients with compromised renal or hepatic function.
7. Patients with chronic gastrointestinal illness such as Irritable Bowel Syndrome(IBS)/Inflammatory Bowel Disease (IBD) etc.
8. Patients with malnutrition, defined as a body mass index (BMI) less than 18.5 kg/m2
in adults and BMI <5% for age based on Centers for Disease Control and Prevention
growth chart in adolescents ≥ 12 years of age.
9. Concomitant use of warfarin, antimicrobial drug(s), anti-diarrheal drug(s) and drug(s)with anti-protozoan activity other than the study drugs.
10. Serious systemic disorders incompatible with the study.
11. History of hypersensitivity to Nitazoxanide or any other ingredient in the formulation.
12. Patients who require immediate effective treatment based on severity of illness
according to Investigator’s judgment.
13. Patients with known immune deficiencies (e.g., cancer patients on chemotherapy,
Patients on oral or systemic steroid therapy, patients with hypogammaglobulinemia).
14. Patient who, in the opinion of the Investigator, would be non-compliant with the
requirements of the study protocol
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Other
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
The proportion of patients with a well clinical response evaluated on (Day 9±1) compared between treatments.
Day 9±1
Secondary Outcome
Outcome
TimePoints
The success proportion for each active treatment compared with placebo, evaluated on (Day 9±1)
Day 9±1
Target Sample Size
Total Sample Size="390" Sample Size from India="390" Final Enrollment numbers achieved (Total)= "390" Final Enrollment numbers achieved (India)="390"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This
is A Multi-Center, Double- Blind, Randomized, Three-arm, Placebo Controlled,
Single Period, Parallel-Group, and Clinical Endpoint Bioequivalence Study. In
this study as per the routine clinical practice patients will be attending the
scheduled visits. So there will be total 3 visits, Visit 1: Screening (Day-7 to
Day-0), Visit 2: Randomization ( Day 0), Visit 3: Efficacy/End of the study
Evaluation (Day 9±1) Visit 1 and 2 can be
performed on the same day if feasible. Apart from the scheduled visits, the
patient can visit clinical site on any day. This will be termed as unscheduled
visit. This
study will be managed by Raptim Research Pvt Ltd.