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CTRI Number  CTRI/2025/01/079007 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 06/02/2026
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 check the Efficacy and Safety of Ondansetron for the Prevention of Chemotherapy Induced Nausea and Vomiting in Patients Receiving Moderately and Highly Emetogenic Chemotherapy 
Scientific Title of Study   A Phase III Randomized Multicentre Double Blind Parallel Group Prospective Non Inferiority Study to Evaluate the Efficacy and Safety of Ondansetron Extended Release Injectable Suspension Intramuscular When Compared to Zofsetron Injection (Ondansetron 8 mg/4 ml) IM for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patients Receiving Moderately and Highly Emetogenic Chemotherapy 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
004/ACRS/CINV/FTF/2023 Version 2.0 Dated 29 APR 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Chandu Gangadhar Devanpally 
Designation  Founder & Managing Director 
Affiliation  Ardent Clinical Research Services 
Address  Room no 01 3rd floor office no 302 303 nyati unitree building yerwada
Pune
Pune
MAHARASHTRA
411006
India 
Phone  9545717447  
Fax  -  
Email  cdevanpally@ardent-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P Veerendra Kumar 
Designation  Head Clinical Affairs Division 
Affiliation  Shilpa Medicare Limited 
Address  Shilpa Medicare Limited Plot No 79 survey no 125 I D A Mallapur Uppal Mandal Hyderabad

Hyderabad
TELANGANA
500076
India 
Phone  9177033911  
Fax  -  
Email  veerendrap.frd@shilpamedicare.com  
 
Details of Contact Person
Public Query  
Name  Dr P Veerendra Kumar 
Designation  Head Clinical Affairs Division 
Affiliation  Shilpa Medicare Limited 
Address  Shilpa Medicare Limited Plot No 79 survey no 125 I D A Mallapur Uppal Mandal Hyderabad

Akola
TELANGANA
500076
India 
Phone  9177033911  
Fax  -  
Email  veerendrap.frd@shilpamedicare.com  
 
Source of Monetary or Material Support  
Shilpa Medicare Ltd hyderabad Shilpa Medicare Limited Plot No 79 survey no 125 I D A Mallapur Uppal Mandal Hyderabad 500076 Telangana India  
 
Primary Sponsor  
Name  FTF Pharma Pvt Ltd 
Address  Block No 193 Part 211 Part Xcelon Industrial Park Chak de India weigh bridge road vasana chacharwadi Ahmedabad 382213 Gujarat India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ezhilarasi R  CHALMEDA ANANDRAO INSTITUTE OF MEDICAL SCIENCE  10-100 survey number 125 Ground floor OPD Area Room No 01 Bommakal Karimnagar 505001
Karimnagar
TELANGANA 		 09440073399
-
ezhil2002@yahoo.com 
Dr Velavan Kandappan  Erode Cancer Care Centre  1/393 velavan nagar perundurai road thindal erode 638012 OPD no 24 GROUND FLOOR
Erode
TAMIL NADU 		 9842334222
-
kvels@rediffmail.com 
Dr Govindraj G  Harshamitra super speciality cancer centre and research institute  Oncology Department Ground Floor Room No 2 Surgical Oncology division Harshamitra Super Speciality Cancer Care And Research Institute No 101/4A Mathur Panchayat Road Madurai Highway Nagamangalam Trichy 620012
Madurai
TAMIL NADU 		 7373542777
-
govindarajganesan@gmail.com 
Dr Anand Prakash Sachan  International Oncology Cancer Institute  International Oncology Cancer Basement OPD number 03 Institute Tower 2 117/Q 40A Sharda Nagar Kanpur Uttar Pradesh 208025 India
Kanpur Dehat
UTTAR PRADESH 		 9807546262
-
anandsachan1978@gmail.com 
Dr Harris Mahammad Sepai  IPGMER and SSKM Hospital  OPD number 19 ground floor department of radiotherapy chest and cancer block AJC Bose Road Kolkata West Bengal 700020 India
Kolkata
WEST BENGAL 		 9038273372
-
harris.nrs@gmail.com 
Dr Vikas L  K R hospital Mysore medical college and research Institute  Oncology Department first floor Irwin Road Mysuru Karnataka 570001 India
Mysore
KARNATAKA 		 9663099774
-
vikilaxman@gmail.com 
Dr Neve Rakesh Suresh  Lifepoint Multispeciality Hospital  Lifepoint Multispeciality Hospital 3rd Floor Clinical Research Department 145/1 Mumbai Banglore Highway Near Hotel Sayaji Wakad Pune 411057 Maharashtra India
Pune
MAHARASHTRA 		 9881143140
-
rakeshneve05@gmail.com 
Dr Suman Ghorai  Nil Ratan Sircar Medical College & Hospital  Radiotherapy building 1st floor Room No 205 Nil Ratan Sircar Medical College and Hospital 138 AJC Bose Road Kolkata West Bengal 700014 India
Kolkata
WEST BENGAL 		 9830169939
-
ghoraisuman199@gmail.com 
Dr Nikhil Mallinath Shirsi  Sangvi Research Multispeciality Hospital  OPD No 02 Ground Floor Sangvi Multispeciality Hospital Pvt Ltd Survey No 71/1/2/189 C S No 2387 Krushna Chowk Krushna Nagar New Sangvi
Pune
MAHARASHTRA 		 7835826155
-
drshirsi.sangvihospital@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
CAIMS CANCER HOSPITAL AND RESEARCH INSTITUTE ETHICS COMMITEE  Approved 
ETHICS COMMITTEE RAJA NURSING HOME KANPUR  Approved 
IEC-SANGVI MULTISPECIALITY HOSPITAL  Approved 
Institutional Ethics Committee Erode Cancer Centre Erode  Approved 
Institutional Ethics Committee Mysore Medical College and Research Institute  Approved 
Institutional ethics Committee Nil ratan sircar medical college  Approved 
Institutional Ethics Committee of Harshmitra Oncology Pvt Ltd  Approved 
IPGME&R Research Oversight Committee  Approved 
lifepoint reasearch Ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R112||Nausea with vomiting, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ondansetron Extended Release Injection suspension 100 mg/ml  1 mL of ondansetron extended release injectable suspension 100 mg/1 mL through IM route Injection in each cycle by slow intramuscular injection (over not less than 30 seconds) 3 hrs before chemotherapy followed by 30 mins before chemotherapy 4 hrs and 8 hrs after chemotherapy  
Comparator Agent  Zofsetron Injection (Ondansetron 8 mg/4 ml  Subjects will be injected with ZOFSETRON INJ 8mg/4ml IM Injection 4 times in each cycle up to 24 mg) by slow intramuscular injection (over not less than 30 seconds) 3 hrs before chemotherapy followed by 30 mins before chemotherapy 4 hrs and 8 hrs after chemotherapy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Willing to provide the signed written informed consent
2.Male or female patient greater than or equal to 18 years of age
3.Male or female patients of child-bearing potential must agree to use medically acceptable forms of contraception during the study
4.Eastern Cooperative Oncology Group performance status less than or equal to 2
5.Patients life expectancy must be more than 6 months
6.Men or Women with confirmed malignancy who planned to receive moderately or highly emetogenic chemotherapeutic drug on day 1 of chemo cycle and who were naive to chemotherapy or had previous chemotherapy greater than or equal to 3 weeks prior to screening
7.Patients who are scheduled to receive Moderately Emetogenic Chemotherapy like Alemtuzumab Bendamustine Carboplatin Cyclophosphamide less than 1500 mg per m2 Cytarabine greater than 1000 mg per m2 Daunorubicin Doxorubicin Epirubicin Idarubicin Irinotecan liposomal injection Ifosfamide Temozolomide Trabectedin Or
8.Patients who are scheduled to receive Highly Emetogenic Chemotherapy (HEC) regimen like Anthracycline/cyclophosphamide combination Carmustine Cisplatin Cyclophosphamide greater than or equal to 1500 mg per m2 Dacarbazine Dactinomycin Mechlorethamine Streptozotocin
9.Female patients of either: non-childbearing potential or child-bearing potential with a negative urine dipstick pregnancy test within 24 hours prior to the first dose of investigational product of Day 1 and with a commitment to consistent and correct use of contraceptive method throughout the clinical trial
10.Hematologic and metabolic status adequate for receiving a moderately or highly emetogenic chemotherapy and fulfilment of the following criteria
a)Total Neutrophils greater than or equal to 1500 per mm3
b) Platelets greater or equal than 100000 per mm3 (Standard units: greater or equal than 100.0 x 109 per Liter
c)Bilirubin less than or equal to 1.5 x Upper Limit of Normal
D)Liver enzymes without known liver metastases, Aspartate aminotransferase and or Alanine aminotransferase less than or equal to 2.5 x ULN with known liver metastases AST and or ALT less than or equal to 5.0 x ULN
Serum Creatinine less than or equal to 1.5 mg per dL (Standard units: less or equal than 132.6 microMOL per Liter or Creatinine Clearance greater than or equal to 60 mL per minute
 
 
ExclusionCriteria 
Details  1 Patients with vomiting or more than mild nausea within 24 hours before study drug administration
2 A QTc interval greater than 500 ms or a greater than 0 ms change from baseline or any other cardiac abnormality predisposing to significant arrhythmia
3 If female is pregnant or lactating.
4 Current use of illicit drugs or current evidence of alcohol abuse.
5 Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1 week prior to Day 1 or between Days 1 to 5 in chemo cycles
6 Any vomiting, retching, or mild nausea (grade greater or equal than I as defined by National Cancer Institute) within 24 hours prior to Day 1.
7 Symptomatic primary or metastatic CNS malignancy.
8 Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active infection or any uncontrolled medical condition (other than malignancy) that, in the opinion of the investigator, may confound the results of the study, represent another potential etiology for emesis and nausea (other than chemotherapy-induced nausea and vomiting, CINV) or pose unwarranted risks in administering the study drugs to the patient.
9 Known hypersensitivity or contraindication to 5-HT3 receptor antagonists like palonosetron ondansetron granisetron dolasetron tropisetron ramosetron or dexamethasone.
10 Participation in a clinical trial involving ondansetron administered in combination with palonosetron
11 Any investigational drugs taken within 4 weeks prior to Day 1 of chemo cycle and or is scheduled to receive any investigational drug during the study
12 Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1 of chemo cycle. However topical and inhaled corticosteroids with a steroid dose of less or equal than 10 mg of prednisone daily or its equivalent are permitted
13 Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy
14 Any medication with known or potential antiemetic activity within 24 hours prior to Day 1 of chemo cycle, including 5 HT3 receptor antagonists example ondansetron granisetron dolasetron tropisetron ramosetron palonosetron) benzamides example metoclopramide alizapride phenothiazines example prochlorperazine promethazine fluphenazine perphenazine thiethylperazine chlorpromazine benzodiazepines except if the subject is receiving such medication for sleep or anxiety and has been on a stable dose for at least seven days prior to Day 1 butyrophenones example haloperidol droperidol anticholinergics example scopolamine, with the exception of inhaled anticholinergics for respiratory disorders ipratropium bromide) chlorphenhyramine), except for prophylactic use for taxane therapy; - domperidone; - mirtazapine oolanzapine; - prescribed 29cannabinoids (e.g. tetrahydrocannabinol or nabilone)
15 History or predisposition to cardiac conduction abnormalities, except for incomplete right bundle branch block.
16 History of risk factors for Torsade de Point (heart failure, hypokalemia, family history of Long QT Syndrome).
17 Severe cardiovascular diseases, including myocardial infarction within 3 months prior to Day 1, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic Congestive Heart Failure (CHF) NYHA class III-IV, and severe uncontrolled arterial hypertension.
18 Any illness or condition that, in the opinion of the investigator, may confound the results of the study or pose unwarranted risks in administering the investigational product to the patient.
19 Concurrent medical conditions that would preclude administration of dexamethasone such as systemic fungal infection or uncontrolled diabetes.
20 Active infection or uncontrolled disease except for malignancy.
21 Started any of the restricted medications.
22 Subjects with increased bleeding risk or increased risk of injection site reactions due to other factors (e.g., concomitant anticoagulant therapy, bleeding disorders).
23 Subjects with any degree of hepatic impairment, based on Child-Pugh classification.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
A proportion of patients with complete response (CR) during the overall treatment (0 to 120 hours) following the administration of chemotherapy in Chemo cycles  1.0 to 120 hours following the administration of chemotherapy in Chemo cycles 
 
Secondary Outcome  
Outcome  TimePoints 
1 A proportion of patients with complete response during the acute phase
2 A proportion of patients with complete response during the delayed phase
3 A proportion of patients following the completion of chemo cycle with total response during the acute phase delayed onset phase, & overall treatment in chemo cycles
4 Proportion of patients following the completion of chemo cycle with major control of emesis less than 2 emetic episodes minor 3 to 5 emetic episodes & failure more than 5 emetic episodes during the onset phase & overall treatment in chemo cycle
6 Number of emetic episodes during the acute & delayed onset phase of chemo cycles
7 Time to first emetic episode during chemo cycles
8 Time to use of rescue medication during chemo cycles 9 Time to treatment failure based on time to first emetic episode time to rescue medication whichever occurs first during chemo cycles
10 Severity of nausea measured daily & overall treatment 		 1 0 to 24 hours following the administration of Chemo cycles
2 24 to 120 hours following the completion of chemo cycles
3 cycles 0 to 120 hours
4 0 to 120 hours
5 Acute and delayed onset phase of chemo cycles
6 during chemo cycles
7 during chemo cycles
8 during chemo cycles
9 during chemo cycles 0 to120 hours
10 0 to 120 using visual analog scales
11 on Day 5 of chemo cycles 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
Final Enrollment numbers achieved (Total)= "240"
Final Enrollment numbers achieved (India)="240" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   28/01/2025 
Date of Study Completion (India) 22/01/2026 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This is a randomized multicentric parallel group active controlled double-blind non-inferiority study to evaluate the efficacy and safety of Ondansetron Extended Release Injectable Suspension Intramuscular When Compared to Zofsetron Injection (Ondansetron 8 mg/4 ml) IM for the prevention of chemotherapy induced nausea and vomiting (CINV) in patients receiving moderately or highly emetogenic chemotherapy
The study will be conducted at approximately 8 to 10 centres in India having qualified investigators.The study will be initiated only after receipt of regulatory and ethics committee (EC) approval. The study will involve screening Hospitalization (treatment period) and safety follow up. A total of 5 visits will be scheduled to the Investigator site
The total duration of study will be approximately 13 weeks which includes 7 days of screening and 3 cycle of treatment and safety follow-up after completion of study treatment (21 days)
All patients will be hospitalized for at least 5 days in each cycle to observe the events till 120 hrs (5 days from the day of Randomization and in every cycle for 3 chemo cycles). All Patients will be randomized in 1:1 ration for Test and Reference. All the Patients further will be stratified according to the emetogenicity of their scheduled chemotherapy regimen (MEC or HEC) and randomization will be done as per stratified block randomization. All the MEC/HEC patients will be equally enrolled in 1:1 ratio in both the arms. Patients will visit the study center for at least 6 hours (±1 hour) before the chemotherapy treatment on Day 1 of each cycle and the patient will remain at study center till Day 5 (0 to 120 hours) of each cycle
 
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