| CTRI Number |
CTRI/2018/10/016216 [Registered on: 31/10/2018] Trial Registered Prospectively |
| Last Modified On: |
30/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
single-dose clinical study evaluating efficacy and safety of standard intramuscular preparation of Paracetamol available in the market for the management of fever |
|
Scientific Title of Study
|
A single center open-label non-comparative single-dose pilot clinical study evaluating efficacy and safety of standard intramuscular preparation of Paracetamol available in the market for the management of fever
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/22/04/17, Ver No 1, dated 29 Jan 2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amarinder Singh |
| Designation |
General Manager |
| Affiliation |
Troikaa Pharmaceuticals Limited |
| Address |
Troikaa Pharmaceuticals Limited Commerce House 1 Satya marg bodakdev
Ahmadabad
GUJARAT
380054
India |
| Phone |
07926856242 |
| Fax |
|
| Email |
amarindersingh@troikaapharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amarinder Singh |
| Designation |
General Manager |
| Affiliation |
Troikaa Pharmaceuticals Limited |
| Address |
Troikaa Pharmaceuticals Limited Commerce House 1 Satya marg bodakdev
GUJARAT
380054
India |
| Phone |
07926856242 |
| Fax |
|
| Email |
amarindersingh@troikaapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratik Shah |
| Designation |
Project Manager |
| Affiliation |
Troikaa Pharmaceuticals Limited |
| Address |
Troikaa Pharmaceuticals Limited Commerce House 1 Satya marg bodakdev
Ahmadabad
GUJARAT
380054
India |
| Phone |
07926856242 |
| Fax |
|
| Email |
pratikshah@troikaapharma.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Troikaa Pharmaceuticals Limited |
| Address |
Troikaa Pharmaceuticals Limited Commerce House 1 Satya marg bodakdev Ahmedabad |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinay Bhomia |
Sanjivani Super Speciality Hospitals Pvt Ltd |
Ground floor department of medicine 1 uday park society near sunrise park vastrapur
Ahmadabad
GUJARAT |
07926306341
07926307165
drvinaybhomia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sanjivani Hospital Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R509||Fever, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Paracetamol solution for Injection |
450 mg per 3 ml
Duration of study is 7 days
Frequency first day of the duration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Having fever oral temperature between 101 to 104 F both inclusive of
recent onset more than 3 days and expected to be hospitalized more than 24 hrs
2 Willing to comply with study requirements including periodic
measurements or examinations laboratory investigations and avoiding
any intramuscular administration during the entire study
duration of 7 days as documented by provision of written Informed
Consent prior to participation in the study |
|
| ExclusionCriteria |
| Details |
1 Fever suspected to be due to neurological infection or any cancer
2 Patient receiving any IM injection for the co morbid condition and where the IM injection are expected to continue
3 High grade fever more than 104 F or suspected septicemia
4 Hypotension inferred from systolic blood pressure more than 90 mmHg
5 Admission in intensive care unit or intensive cardiac care unit
6 Severe kidney creatinine more than 2 mg per dl or liver disease SGOT and SGPT more than 3 times ULN and based on discretion of the investigator
7 Patients with serum CPK levels more than 5 times the ULN for that gender |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 Proportion of completed patients achieving target oral temperature |
180 ± 15 minutes after study drug administration or before |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Mean reduction in oral temperature at each time point compared to
baseline
2 Proportion of patients administered rescue drug before 180 minutes from administration of study drug
|
Proportion of patients administered rescue drug before 180 minutes |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
22/11/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The usual dose in adults is 500 mg to 1 gm per administration that can be given in 4 doses (maximum dosage 4 gm/day). However, an intramuscular formulation delivering 500 mg of paracetamol is currently not approved/available, making dosing very inconvenient. This study is planned as a pilot study as instructed by the DCG(I), in the process of evaluation of parent 500 mg delivering formulation developed by Troikaa Pharmaceuticals Limited. |