| CTRI Number |
CTRI/2011/03/001653 [Registered on: 28/03/2011] Trial Registered Prospectively |
| Last Modified On: |
02/01/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to assess the effectiveness of paracetamol Immediate Release tablets in patients with fever. |
|
Scientific Title of Study
|
An open label, randomized, controlled multicentre study to assess the effectiveness and tolerability of Para IR (Panacea Biotec Ltd, India) in comparison to Calpol tablets (GlaxoSmithKline Pharmaceutical Ltd, India) in patients with Fever |
| Trial Acronym |
Para IR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PBL/CR/2010/07/CT |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arani Chatterjee |
| Designation |
Senior Vice President |
| Affiliation |
|
| Address |
Senior Vice President-CRD
B-1 Extn/G-3,
Mohan Co-op. Industrial Estate, Mathura Road
New Delhi
New Delhi
DELHI
110044
India |
| Phone |
011-41679000 |
| Fax |
011-41578085 |
| Email |
aranichatterjee@panaceabiotec.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arani Chatterjee |
| Designation |
Sr VP |
| Affiliation |
|
| Address |
B-1 Extn/G-3,
Mohan Co-op. Industrial Estate, Mathura Road
New Delhi
New Delhi
DELHI
110044
India |
| Phone |
011-41679000 |
| Fax |
011-41578085 |
| Email |
aranichatterjee@panaceabiotec.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arani Chatterjee |
| Designation |
Sr VP |
| Affiliation |
|
| Address |
B-1 Extn/G-3,
Mohan Co-op. Industrial Estate, Mathura Road
New Delhi
New Delhi
DELHI
110044
India |
| Phone |
011-41679000 |
| Fax |
011-41578085 |
| Email |
aranichatterjee@panaceabiotec.com |
|
|
Source of Monetary or Material Support
|
| Panacea Biotec Ltd, New Delhi |
|
|
Primary Sponsor
|
| Name |
Panacea Biotec Ltd |
| Address |
B-1 Extn/G-3,
Mohan Co-op. Industrial Estate, Mathura Road
New Delhi
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr KK Pandey |
Dr. K.K .Pandey Clinic |
Near VATS ENT Centre, Yamuna Vihar Road, Moujpur. Delhi-110053
New Delhi
DELHI |
09810364005
dr_kk_pandey@ymail.com |
| Dr Paras Gangwal |
Dr. Paras Gangwal |
Consultant Physician and Cardiologist, 17- RPS, DDA Flats, Mansarover Park, Delhi - 31
New Delhi
DELHI |
09811305970
drparasgangwal@yahoo.co.in |
| Dr Gaurav Rao |
Yadav Hospital |
Yadav Hospital, C- 1 Opp Mennakshi Public School, Sector 10 A, Gurgaon 122 001
Gurgaon
HARYANA |
09810030900
drgauravrao@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Alert Ethics Committee (Dr Gaurav Rao) |
Approved |
| Alert Ethics Committee (Dr KK Pandey) |
Approved |
| Alert Ethics Committee (Dr Paras Gangwal) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients having fever at least 38 degrees celsius or 100.4 degrees Fahrenheit , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Para IR tablets |
Dose: 500 mg
Route: Oral
Duration: Single dose |
| Comparator Agent |
Paracetamol (GlaxoSmithKline Pharmaceutical Ltd, India) |
Dose: 500 mg
Route: Oral
Duration: Single dose
Paracetamol (Calpol tablets) will act as comparator agent in this trial |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex, 18-65years
2. Patients having fever at least 380C or 100.40F
3. Patients willing to give informed consent
4. Patients able to take oral medications
|
|
| ExclusionCriteria |
| Details |
1. Subjects requiring hospitalization
2. Subjects with known or suspected hypersensitivity to paracetamol or any the constituents of the formulation.
3. Subjects who have received any other investigational drug within 1 month prior to screening or enrollment.
4. Subjects who have received Paracetamol or any NSAID within 6 hours prior to enrollment.
5. Subjects who are receiving other medications or who have disease conditions that could interfere with the evaluation of drug efficacy or drug safety.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of Para IR (Panacea Biotec Ltd) with Calpol tablets (GlaxoSmithKline Pharmaceutical Ltd, India) for faster relief of Fever |
One and half Hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the tolerability of Para IR (Panacea Biotec Ltd) with Calpol tablets (GlaxoSmithKline Pharmaceutical Ltd, India) in patients with Fever |
One and half Hour |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/03/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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)?
|
|
Brief Summary
|
Panacea Biotec Ltd has developed a formulation of Paracetamol (Para IR) which is Immediate Release. This is expected to relieve the fever faster then the existing Paracetamol formulations. To show the superior effectiveness of product Para IR for faster relief of fever it has been planned to compare with one of the most commonly used formulation of Paracetamol i.e. Calpol tablets of GlaxoSmithKline Pharmaceutical Ltd. |