| CTRI Number |
CTRI/2024/04/065708 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the efficacy and safety of Amisulpride injection for Prevention of Post-Operative Nausea and Vomiting (PONV) in Adult Surgical Patients. |
|
Scientific Title of Study
|
A Phase IV, Prospective, Single Arm, Multi-Center, Open Label Clinical Study to Evaluate the Efficacy and Safety of Amisulpride 5 mg/2 mL for IV Injection in Prevention of Post-Operative Nausea and Vomiting (PONV) in Adult Surgical Patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/2023/54, Version No.: 00 and Dated Aug 09, 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajasekhara Reddy Tamma |
| Designation |
Managing Director |
| Affiliation |
Clinwave Research Pvt. Ltd. |
| Address |
Clinwave Research Pvt. Ltd.,
LIG: B/466, H. No.: 1-16-10/466,
Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.).
Medchal
TELANGANA
500062
India |
| Phone |
7989233379 |
| Fax |
|
| Email |
dr.sekhar@clinwave.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harsh Shah |
| Designation |
AGM - Medical Affair & Pharmacovigilance |
| Affiliation |
La Renon Healthcare Pvt. Ltd. |
| Address |
La Renon Healthcare Pvt. Ltd.,
207-208, ISCON Elegance, Circle P,
Prahaldnagar Crossroads, SG Highway.
Ahmadabad
GUJARAT
380015
India |
| Phone |
9879540270 |
| Fax |
|
| Email |
harsh.shah@larenon.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harsh Shah |
| Designation |
AGM - Medical Affair & Pharmacovigilance |
| Affiliation |
La Renon Healthcare Pvt. Ltd. |
| Address |
La Renon Healthcare Pvt. Ltd.,
207-208, ISCON Elegance, Circle P,
Prahaldnagar Crossroads, SG Highway.
Ahmadabad
GUJARAT
380015
India |
| Phone |
9879540270 |
| Fax |
|
| Email |
harsh.shah@larenon.com |
|
|
Source of Monetary or Material Support
|
| La Renon Healthcare Pvt. Ltd.,
207-208, ISCON Elegance, Circle P,
Prahaldnagar Crossroads,
SG Highway,
Ahmedabad-380015, Gujarat, India.
|
|
|
Primary Sponsor
|
| Name |
La Renon Healthcare Pvt. Ltd., |
| Address |
207-208, ISCON Elegance, Circle P,
Prahaldnagar Crossroads,
SG Highway,
Ahmedabad-380015, Gujarat, India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr G Ramesh |
Anu Hospitals |
Research Room, Kovelamudivari Street, Suryaraopet, Vijayawada-520002.
Krishna
ANDHRA PRADESH |
9246195564
rameshdrg@gmail.com |
| Dr Debayan Chowdhury |
College of Medicine & Sagore Dutta Hospital |
Department of Surgery, College of Medicine & Sagore Dutta Hospital,
578, B.T. Road, Kamarhati,
Kolkata-700058
Kolkata
WEST BENGAL |
8584063373
dbayn169@gmail.com |
| Dr Shiv Kumar Bunkar |
Jawahar Lal Nehru (J.L.N) Medical College |
Department of General Surgery, Kala Bagh, Ajmer-305001.
Ajmer
RAJASTHAN |
9829072396
clinical.jln@gmail.com |
| Dr Prabhat Kumar Sharma |
Maharaja Agrasen Superspeciality Hospital |
Research Room, Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar Nagar,
Jaipur-302039.
Jaipur
RAJASTHAN |
9983995050
pksharma.clinical@gmail.com |
| Dr Kamlesh Kumar Agrawal |
Om Hospital |
Research Room, Near H.P. Petrol Pump, Mahadev Ghat Road, Raipura, Raipur-492001.
Raipur
CHHATTISGARH |
9827162333
drkamleshagrawal@gmall.com |
| Dr Sathwara Kunal Girishkumar |
Sheth Vadilal Sarabhai General Hospital & Sheth Chinai Maternity Hospital |
Research Room, Ellisbridge,
Ahmedabad-380006
Ahmadabad
GUJARAT |
7600674378
sathwarakunal300@gmail.com |
| Dr Vaibhav Raj Singh |
SMC Heart Institute and IVF Research Centre |
Research Room, Infront of BSNL Office, Vidhan Sabha Road, Khamardih, Raipur-492007.
Raipur
CHHATTISGARH |
9890716410
drvaibhavrajsingh@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Aatman Hospital (Sheth Vadilal Sarabhai General Hospital & Sheth Chinai Maternity Hospital) |
Approved |
| Institutional Ethics Committee, Anu Hospitals |
Approved |
| Institutional Ethics Committee, College of Medicine & Sagore Dutta Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Jawahar Lal Nehru Medical College |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Superspeciality Hospital |
Approved |
| Institutional Ethics Committee, Om Hospital |
Approved |
| SMC Heart Institute Institutional Ethics Committee, SMC Heart Institute and IVF Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amisulpride 5 mg/2 mL for IV Injection |
5 mg as a single intravenous injection infused over 1 to 2 minutes at the time of induction of anesthesia. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients aged between 18 to 75 years (both inclusive).
2. Patients undergoing elective surgery (laparoscopic gynecological or abdominal surgery) under general anaesthesia requiring and inhalation anaesthesia is maintained for more than 1 hour, but patients who receive purely diagnostic surgery cannot be enrolled.
3. Patients with the Body Mass Index (BMI) ≤ 30 kg/m2 at screening visit.
4. Patients with at least 2 of the following risk factors for PONV:
a. Past history of PONV and/or motion sickness
b. Habitual non-smoking status
c. Female sex
d. Expected to receive opioid analgesia post-operatively.
5. Patients with American Society of Anesthesiologists (ASA) risk score I-III.
6. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening visit.
7. Patients with ability to fully understand the study procedures and provide written, signed and dated informed consent form.
8. Patients willing to comply with all the protocol related requirements. |
|
| ExclusionCriteria |
| Details |
1. Patients undergoing day case surgery.
2. Patients undergoing intra-thoracic, transplant or central nervous system surgery or any surgery where post-operative emesis may pose a significant danger to the patient.
3. Patients planned to receive only a local anesthetic and/or regional neuraxial (intrathecal or epidural) block.
4. Patients who are scheduled to be transferred to the ICU after surgery.
5. Patients who are expected to need a naso- or oral-gastric tube in situ after surgery is completed.
6. Patients who have a documented, clinically significant cardiac arrhythmia or congenital long QT syndrome (male ≥450 ms or female ≥460 ms).
7. Patients with clinically significant impaired hepatic and renal function (ALT and/or AST ≥2.5 X the ULN, Total bilirubin ≥1.5 X the ULN and/or Serum creatinine ≥1.5 X ULN) at screening visit.
8. Patients who have received Amisulpride active ingredient for any indication within the last 2 weeks.
9. Patients who are allergic to Amisulpride active ingredient or any of the excipients of Amisulpride.
10. Patients with a significant, ongoing history of vestibular disease or dizziness.
11. Patients with a history of intestinal obstruction.
12. Patients with a known history of prolactin-dependent tumor (e.g., pituitary gland prolactinoma or breast cancer) or phaeochromocytoma.
13. Patients with pre-existing nausea or vomiting in the 24 hours before surgery.
14. Patients treated with regular anti-emetic therapy including corticosteroids.
15. Patients being treated with medications which could induce torsades de pointes, including Class Ia antiarrhythmic agents such as Quinidine, Disopyramide, Procainamide; Class III antiarrhythmic agents such as Amiodarone and Sotalol; and other medications such as Bepridil, Cisapride, Thioridazine, Methadone, IV Erythromycin, IV Vincamine, Halofantrine, Pentamidine and Sparfloxacin.
16. Patients being treated with Levodopa or other dopamine drugs.
17. Female patients who are pregnant or breast feeding.
18. Patients with a history of drug or alcohol abuse within 6 months before enrollment.
19. Patients diagnosed with Parkinson disease.
20. Patients with a history of epilepsy.
21. Patients who have received anti-cancer chemotherapy in the previous 4 weeks of surgery.
22. Patients with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
23. Patients who may increase study-related risks or interfere with the interpretation of study results in the opinion of the investigator, who are considered unsuitable for enrolment by the investigator. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| No episodes of emesis (vomiting or retching) and no use of rescue medication in the first 24h after surgery. |
Visit 2 - Baseline or Enrolment visit / Day 1 and
Visit 3 - End of the study visit / Day 2.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Criteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the end of surgery. |
Visit 2 - Baseline or Enrolment visit / Day 1 and
Visit 3 - End of the study visit / Day 2. |
| Number of patients experiencing an episode of no nausea scored Less than 1 of 0-10 verbal response scale during the 24 hours period after the completion of surgery. |
Visit 2 - Baseline or Enrolment visit / Day 1 and
Visit 3 - End of the study visit / Day 2.
|
| Number of patients with nausea score Greater than 4 on 0-10 verbal response scale. |
Visit 2 - Baseline or Enrolment visit / Day 1,
Visit 3 - End of the study visit / Day 2 and
Visit 4 - Post treatment safety follow up visit / Day 7. |
| An assessment of a patient experiencing an episode of emesis (vomiting/ retching) during the 24 hours after the completion of the surgery. |
Visit 2 - Baseline or Enrolment visit / Day 1 and
Visit 3 - End of the study visit / Day 2.
|
| Adverse events or serious adverse events reported during the study. |
Throughout the Study |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
29/04/2024 |
| Date of Study Completion (India) |
22/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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 phase IV, Prospective, Single Arm, Multi-Center, Open Label Clinical Study to Evaluate the Efficacy and Safety of Amisulpride 5 mg/2 mL for IV Injection in Prevention of Post-Operative Nausea and Vomiting (PONV) in Adult Surgical Patients.Patients who are willing and able to participate in the study will sign and date the Informed Consent Form on the day of screening visit (Visit 1). During this screening period, patients who are willing to give consent will be evaluated for all the eligibility criteria. Eligible patients aged between 18 to 75 years (both inclusive) fulfilling all inclusion criteria and none of the exclusion criteria will be considered for the study. After confirming all inclusion criteria and none of the exclusion criteria the patient will be enrolled into the study.
All eligible patients will be screened and enrolled in the study. Eligible patients will be enrolled to receive the treatment of Amisulpride 5 mg/2 mL IV as a single dose before surgery at the time of Anaesthesia administration. |