| CTRI Number |
CTRI/2020/07/026634 [Registered on: 17/07/2020] Trial Registered Prospectively |
| Last Modified On: |
02/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to assess the safety and efficacy of FDC of Propranolol Hydrochloride IP
Plus Clonazepam IP Tablets in patients with anxiety disorders. |
|
Scientific Title of Study
|
A post marketing, multicentre, single-arm, prospective clinical trial to assess the safety and efficacy of FDC of Propranolol Hydrochloride IP
Plus Clonazepam IP Tablets in patients with anxiety disorders.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BRADPL/PHC/PMS/07/19; Version 2.0; 09 Dec 2019; |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhinav Tewari |
| Designation |
Consultant |
| Affiliation |
Maharaja Agrasen Hospital |
| Address |
Maharaja Agrasen Hospital Department of Psychiatry
Dwarka Flyover
Pocket 4
Sector 1
Dwarka New Delhi
South West
DELHI
110045
India |
| Phone |
9975694579 |
| Fax |
|
| Email |
abhinav.at@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Datta |
| Designation |
Managing Director |
| Affiliation |
Biosite Research Private Limited |
| Address |
740 2nd Floor 14th Main Road Kumarswamy Layout Stage 1 Bangalore
Bangalore
KARNATAKA
560078
India |
| Phone |
08026667707 |
| Fax |
|
| Email |
aditi.datta@biositeindia.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Datta |
| Designation |
Managing Director |
| Affiliation |
Biosite Research Private Limited |
| Address |
740 2nd Floor 14th Main Road Kumarswamy Layout Stage 1 Bangalore
KARNATAKA
560078
India |
| Phone |
08026667707 |
| Fax |
|
| Email |
aditi.datta@biositeindia.com |
|
|
Source of Monetary or Material Support
|
| Akums Drugs & Pharmaceuticals Limited
304
Mohan Place
Local Shopping Complex
Block - C
Saraswati Vihar
New Delhi 110034 |
|
|
Primary Sponsor
|
| Name |
Akums Drugs Pharmaceuticals Limited |
| Address |
304, Mohan Place, L.S.C.,
Block – C, Saraswati Vihar, Delhi – 110034 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nitant Singhal |
Maharaja Agrasen Hospital |
Dwarka Flyover, near Shiv Shankar petrol pump, Pocket 4, Sector 1 Dwarka, New Delhi
South West
DELHI |
9868220809
nitantsinghal1@gmail.com |
| Dr Sudhir Kumar Bhatnagar |
Abhinav Multispeciality Hospital |
Abhinav Multispecialty Hospital Pvt., Ltd,10, No Puliya, Lashkaribag Main Road, Nagpur India-440017
Nagpur
MAHARASHTRA |
9823148978
abhinavhospitalres13@gmail.com |
| Dr Abdul Qavi |
Dr. Ram Manohar Lohia Institute of Medical Sciences |
Vibhuti Khand, Gomti Nagar, Lucknow, Uttar Pradesh 226010
Lucknow
UTTAR PRADESH |
9450417111
drqavi2008@gmail.com |
| Dr Nishanth Vemana |
Excel Hospital |
Excel Hospital - A Unit Of Bhargava Sai Healthcare 1-5-56/29, Near IG Statue,Old Alwal Medchal, Secunderabad, Medchal–Malkajgiri Telangana - 500010 India
Hyderabad
TELANGANA |
9686142884
vemananishanth12@gmail.com |
| Dr Lalit Kumar |
GSVM Medical College |
GSVM MEDICAL COLLEGE KANPUR, SWAROOP NAGAR SWAROOP NAGAR KANPUR, Kanpur Nagar Uttar Pradesh - 208002 India.
Kanpur Nagar
UTTAR PRADESH |
9889264230
lalit85gsvm@gmail.com |
| Dr Amlan Kusum Jana |
Healthpoint Multispeciality Hospital |
Health Point Hospital, 21 Prannath Pandit Street Opposite Lansdowne, Paddapukur Kolkata Kolkata West Bengal – 700025, India
Kolkata
WEST BENGAL |
7439552697
akusumjana@gmail.com |
| Dr Surjyaprakash Sibanarayan Choudhury |
Institute of Medical Sciences & Sum Hospital |
IMS and SUM Hospital
Department of Neurology
K8 Kalinga Nagar
Bhubaneshwar 751003
Khordha
ORISSA |
9556062436
drsurjyaprakash@gmail.com |
| Dr Suresh Babu |
Krishna Institute of Medical Sciences |
Department of Neurology
1-8-31/1
Minister Road, Secunderabad 500003
Hyderabad
TELANGANA |
8940005712
drsuresh.babu85@gmail.com |
| Dr Nikhil P chougule |
Om Sai Onco Surgery Center |
457/10 C, Dr. Lad Colony, Sugar Mill Corner, Main Road, Kasaba Bawada, Kolhapur 416006
Kolhapur
MAHARASHTRA |
9890533993
n_chougule@hotmail.com |
| Dr Sameer Agarwal |
Tulsi Hospital India Limited |
Tulsi Hospital India Limited, 14/116-A,Civil Lines, Kanpur -208001.
Kanpur Nagar
UTTAR PRADESH |
8175910410
agarwalsameer66@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GSVM MEDICAL COLLEGE |
Submittted/Under Review |
| Excel Hospital Institutional Ethics Committee |
Approved |
| Health Point Ethics Committee |
Submittted/Under Review |
| Institutional Ethics committee, Dr. Ram Manohar Lohia Institute of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics Committee, IMS & SUM Hospital |
Submittted/Under Review |
| Institutional Ethics committee, Maharaja Agrasen Hospital |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Hospital |
Approved |
| Jasleen Hospital Ethics Committee |
Approved |
| KIMS Ethics Committee, Krishna Institute of Medical Sciences |
Approved |
| Om Sai Onco Institutional Ethics Committee, Om Sai Onco Surgery Center |
Submittted/Under Review |
| Tulsi Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fixed Dose Combination (FDC) Propranolol Hydrochloride IP 10MG / 10MG / 20MG /20MG and Clonazepam IP 0.25MG / 0.5MG / 0.25MG /0.5MG |
1 tablet of suitable strength of FDC of Propranolol Hydrochloride IP and Clonazepam IP twice a day |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients age 18 - 65 years.
2. Primary diagnosis of generalized anxiety disorder (GAD) either moderate or severe as per
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) as confirmed by the
MINI at Screening, in addition to a psychiatric evaluation by a board- certified or Biohavenapproved
board-eligible
psychiatrist;
The
duration
of illness
must
be
≥ 1 year
3. Hamilton Anxiety Scale (HAM-A) score at least 14.
4. Determined by the investigator to be medically stable at baseline/randomization as assessed by
medical history, physical examination, laboratory test results, and electrocardiogram testing.
Subjects must be physically able and expected to complete the trial as designed.
5. Literate and can understand and sign informed consent.
6. Women of childbearing potential must have a negative serum pregnancy test at screening and a
negative urine pregnancy test prior to dosing at Baseline. |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating female patients.
2. Hypersensitivity and/or skin reactions to drug constituents
3. Patients with congestive heart failure
4. Patients with bronchospastic lung disease, or severe respiratory insufficiency
5. Patients planned to be undergoing any major surgery
6. Patients with diabetes and specifically prone to hypoglycaemia
7. Patients with a history of hypothyroidism
8. Wolf-Parkinson-White Syndrome and tachycardia
9. Patients with impaired hepatic or renal function
10. Patients with sleep apnoea, myasthenia gravis and narrow-angle glaucoma.
11. Patients using any of the prohibited medications:
a) Opioids) Use of alcohol/CNS depressants
c) Antiepileptic drugs phenytoin, phenobarbital, carbamazepine, lamotrigine and
valproate
d) drugs that have an effect on CYP2D6, 1A2, or 2C19 metabolic pathways
e) Cardiovascular drugs: antiarrhythmics, Digitalis Glycosides, Calcium Channel Blockers,
ACE Inhibitors, Alpha Blockers, Reserpine, inotropic agents, Isoproterenol and
Dobutamine,
f) Nonsteroidal Anti-Inflammatory Drugs, Antidepressants, Anesthetic Agents, Warfarin,
Neuroleptic Drugs, Thyroxine. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The proportion of participants who experienced at least one adverse event (AE)
• Proportion of discontinuations due to AEs
• Incidence of Serious AEs
• Changes in the laboratory parameters from baseline to the end of treatment.
|
Day 1/Week 1; Day 15±2/ Week 3 ; Day 42±2/ Week 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical Global Impression-Severity Scale (CGI-S)
Clinical Global Impression-Anxiety Scale (CGI-anxiety)
Clinical Global Impression-Sleep Scale (CGI-sleep). |
Day 1/Week 1; Day 15±2/ Week 3 ; Day 42±2/ Week 6 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
31/07/2020 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A post marketing, multicentre, single-arm, prospective clinical trial to assess the safety and efficacy of FDC of PROPRANOLOL HYDROCHLORIDE IP + CLONAZEPAM IP Tablets in patients with anxiety disorders.â€
Primary Objective To assess the safety of FDC PROPRANOLOL HYDROCHLORIDE IP 10MG / 10MG / 20MG / 20MG + CLONAZEPAM IP 0.25MG / 0.5MG / 0.25MG / 0.5MG Tablets in patients with anxiety disorders Secondary Objective To assess the efficacy of FDC PROPRANOLOL HYDROCHLORIDE IP 10MG / 10MG / 20MG /20MG + CLONAZEPAM IP 0.25MG / 0.5MG / 0.25MG / 0.5MG Tablets in patients with anxiety disorders.
Investigational product Fixed dose combination (FDC) of PROPRANOLOL HYDROCHLORIDE IP IP 10MG / 10MG / 20MG /20MG + CLONAZEPAM IP 0.25MG / 0.5MG / 0.25MG /0.5MG Tablets |