| CTRI Number |
CTRI/2009/091/000879 [Registered on: 05/01/2010] |
| Last Modified On: |
30/01/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Phase III Randomized Controlled Study Of Efficacy & Tolerability Of Fixed Dose Combination Of Paracetamol 500 Mg + Phenylephrine Hydrochloride 5mg + Diphenhydramine 25 Mg + Caffeine 30 Mg (Nasivion Tablets) Versus Paracetamol 500 Mg And A Fixed Dose Combination Containing Paracetamol 500 Mg + Chloropheneraminemaleate 2 Mg + Phenylephrine 10 Mg (Control) In Patients With Common Cold (Coryza) |
|
Scientific Title of Study
|
A Phase III Randomized Controlled Study Of Efficacy & Tolerability Of Fixed Dose Combination Of Paracetamol 500 Mg + Phenylephrine Hydrochloride 5mg + Diphenhydramine 25 Mg + Caffeine 30 Mg (Nasivion Tablets) Versus Paracetamol 500 Mg And A Fixed Dose Combination Containing Paracetamol 500 Mg + Chloropheneraminemaleate 2 Mg + Phenylephrine 10 Mg (Control) In Patients With Common Cold (Coryza) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MERCK/Nas/Tab/01/09 |
DCGI |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
Not Applicable
N/A
India |
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Amarinder Singh |
| Designation |
Medical Advisor |
| Affiliation |
Merck Limited |
| Address |
5th Floor, Shiv Saagar Estate
Dr.Annie Besant Road
Mumbai
MAHARASHTRA
400018
India |
| Phone |
91-22-66609070 |
| Fax |
91-22-24936046 |
| Email |
amarinder.singh@merck.co.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Khokan Debnath |
| Designation |
Assistant Manager Clinical Operation |
| Affiliation |
|
| Address |
5th Floor, Shiv Saagar Estate
Dr. Annie Besant Road
Mumbai
MAHARASHTRA
400018
India |
| Phone |
91-22-66609003 |
| Fax |
91-22-24936046 |
| Email |
khokan.debnath@merck.co.in |
|
Source of Monetary or Material Support
Modification(s)
|
| Merck Limited,A-Shivsagar Estate, Dr Annie Besant Road, Mumbai 400018 India |
|
Primary Sponsor
Modification(s)
|
| Name |
Merck Limited |
| Address |
A Shivsagar Estate
Dr Annie Besant Road
Mumbai 400018
Maharashtra
India
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Infinity Solutions |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Maitri Kaushik |
Bharati Vidyapeeth University Medical College & Bharati Hospita |
Bharati Vidyapeeth University Medical College & Bharati Hospita,Pune-Satara Road-400037
Pune
MAHARASHTRA |
+91- 98220 89965
maitri.kaushik@gmail.com |
| Dr.Rajendra Pagare |
Dr.Pagare?s ENT Hospital |
Dr.Pagare?s ENT Hospital,Old Pandit Colony, Opp. KTHM College, Gangapur Rd.-422002
Nashik
MAHARASHTRA |
+91 -98220 45917
rajendrapagare@gmail.com |
| Dr. Manmohan V. Jagade |
Grant Medical College & Sir J.J.Group of Hospitals |
Professor & Head, Dept. of Otorhinolaryngology,Grant Medical College & Sir J.J.Group of Hospitals-400 008
Mumbai
MAHARASHTRA |
+91 - 93235 93627
mohanjagade@hotmail.com |
| Dr.Mihir Suryavanshi |
Suryaprabha Nursing Home |
Suryaprabha Nursing Home,Paud Road-411 038
Pune
MAHARASHTRA |
+91- 98220 11773
miheerms@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee, Pratik Society, 16/251, K.N.Nagar‐1, Vikhroli (E), Mumbai‐ 400 083. |
Approved |
| Institutional Ethics Committee, Department of Pharmacology, Grand Medical College & Sir J.J Group of Hospitals |
Approved |
| nstitutional Ethics Committee -Bharati Vidyapeeth University |
Approved |
| Shatabdi Superspeciality Hospital Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Common Cold (Coryza), |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Control Arm 1 Tablet Calpol
Control Arm 2 Tablet Febrex Plus |
Control Arm -1: Paracetamol 500 mg, One tablet three times a day.
Control Arm -2 : Cpmbination of Paracetamol 500 mg + chloropheneraminemaleate 2 mg + phenylephrine 10 mg
One tablet three times a day. |
| Intervention |
Nasivion Tablet |
Combination of paracetamol 500 mg + phenylephrine hydrochloride 5mg + diphenhydramine 25 mg + caffeine 30 mg. one tablet three times a day. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.All subjects selected for this study will be within the age group of 18 to 60 years.
2.Patients suffering from common cold (coryza) associated with symptoms of rhinorrhoea, nasal congestion and fever.
3.Patients who have provided with their informed consent.
4.Patients who can come for follow-up as per the study schedule
|
|
| ExclusionCriteria |
| Details |
1. Patients with known hypersensitivity to ingredients of study/active comparators.
2. Patients with productive cough.
3. Patients with clinical suspicion of any local (nasal) or systemic bacterial infection.
4. Patients having hypertension (defined as sitting blood pressure of >140 mm systolic and/or 90 mm diastolic)
5. Patients with any previous H/O or current episode of cardio-vascular disorders.
6. Known renal or hepatic illness.
7. Pediatric and Pregnant patients.
8. Patients with H/O drug/alcoholic/substance abuse.
9. Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Clinical response is defined as complete resolution of the symptoms of coryza (sneezing, nasal blockade, rhinorrhoea & loss of smell). |
Post 5 day treatment period |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
-Fever evaluated by measuring the body surface temperature from auxillary pit
-Dry cough evaluated on 4 point scale.
Body ache evaluated on 0-10 Visual Analogue Scale (VAS) by clinical Investigator.
-Change in the symptom scores
-Physicians Global Assessment of Response to Therapy (PGART) on a 4-point scale.
-Patients Global Assessment of Tolerability to Therapy (PGATT) on a 4-point scale.
|
-at baseline, day 3 & day 5. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
02/11/2009 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized , open label phase Phase III Randomized Controlled Study Of Efficacy & Tolerability Of Fixed Dose Combination Of Paracetamol 500 Mg + Phenylephrine Hydrochloride 5mg + Diphenhydramine 25 Mg + Caffeine 30 Mg (Nasivion Tablets) Versus Paracetamol 500 Mg And A Fixed Dose Combination Containing Paracetamol 500 Mg + Chloropheneraminemaleate 2 Mg + Phenylephrine 10 Mg (Control) In Patients With Common Cold (Coryza) with 4 centres all across India. The study period is for 5 days and roughly 200 patients will be included in the study, 50 patients at each site. The primary outcome will be the clinical response defined as complete resolution of the symptoms of coryza (sneezing, nasal blockade, rhinorrhoea & loss of smell. The estimated number of patients is 200 for 4 sites. |