| CTRI Number |
CTRI/2017/12/010962 [Registered on: 22/12/2017] Trial Registered Prospectively |
| Last Modified On: |
30/01/2020 |
| 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 Study to Evaluate the Safety, Efficacy and Tolerability of Clonazepam 0.25 mg and Clonazepam 0.25mg with Propranolol 10/20 mg in Patients With Anxiety disorders |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Multicentric, Active Controlled, Phase IV Clinical Study to Evaluate the Safety, Efficacy and Tolerability of Fixed Dose Combination of Clonazepam 0.25 mg and Propranolol 10/20 mg In Patients With Anxiety Disorders |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MLPB/05/2017, Version 1.0, Dated 05-May-2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjula |
| Designation |
Vice President, Department of Medical Services |
| Affiliation |
Micro Labs Limited |
| Address |
#27, Race Course Road, Bangalore
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
|
| Email |
drmanjula@microlabs.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjula |
| Designation |
Vice President, Department of Medical Services |
| Affiliation |
Micro Labs Limited |
| Address |
#27, Race Course Road, Bangalore
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
|
| Email |
drmanjula@microlabs.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Kumar M |
| Designation |
Senior Manager - Department of Medical Services |
| Affiliation |
Micro Labs Limited |
| Address |
#27, Race Course Road, Bangalore
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
|
| Email |
krishna@microlabs.in |
|
|
Source of Monetary or Material Support
|
| Micro Labs Limited, 27, Race Course Road, Bangalore -01 |
|
|
Primary Sponsor
|
| Name |
Micro Labs Limited |
| Address |
27, Race Course Road, Bangalore -01 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anu Kant Mital |
Chhatrapati Shivaji Maharaj Hospital |
Kalwa Naka Belapur Road Kalwa Thane Maharashtra 400605
Thane
MAHARASHTRA |
9820164327
akmital@gmail.com |
| Dr Rajesh Kumar |
Indira Gandhi Institute of Medical Sciences |
OPD Block, Department of Psychiatry, Sheikhpura, Patna
Patna
BIHAR |
9871554629
kartavyarajesh2003@gmail.com |
| Dr Nilsih Shah |
LTMMC & LTMGH Sion Hospital |
Dr Babasaheb Ambedkar Road
Sion (West) Mumbai 400022
Mumbai
MAHARASHTRA |
9821788658
drnilshah@hotmail.com |
| Dr Rajesh Nagpal |
Manobal Klinik |
A-2 Rajouri Garden New Delhi 110027
New Delhi
DELHI |
9810037469
drnagpalrajesh23@gmail.com |
| Dr SVB Gupta |
Rajiv Gandhi Institute of Medical Sciences and Government General Hospital, Srikakulam |
Rajiv Gandhi Institute of Medical Sciences and Government General Hospital, No. 1, 2 nd floor, Dept of Psychiatry, Shanti Nagar Colony, Balaga, Srikakulam, Andhra Pradesh 532001
Srikakulam
ANDHRA PRADESH |
9912320517
muralidhargudla@yahoo.com |
| Dr Mahesh R Gowda |
Spandana Nursing Home |
546/46 6th Main Road Opp Ram Mandir Road 4th Block Rajajinagar Bengaluru Karnataka 560010
Bangalore Rural
KARNATAKA |
9035560000
maheshrgowda@yahoo.com |
| Dr R Ramanathan Sathianathan |
Sri Ramachandra Medical College and Research Institute |
No 1 Ramachandra Nagar Chennai Tamil Nadu 600116
Chennai
TAMIL NADU |
9841019910
sathianathen6@yahoo.com |
| Dr Manushree Gupta |
VNMC & Safdarjung Hospital |
Near AIIMS Hospital Ansari Nagar New Delhi Delhi 110029
New Delhi
DELHI |
9711195900
manushree@outlook.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee Indira Gandhi Institute of Medical Sciences |
Approved |
| Institutional Clinical Ethics Committee, Chhatrapati Shivaji Maharaj Hospital |
Approved |
| Institutional Ethics Committee RIMS Srikakulam |
Approved |
| Institutional Ethics Committee VNMC & Safdurjung Hospital, New Delhi |
Approved |
| Institutional Ethics Committee, Human Research Lokmanya Tilak Municipal Medical College at Staff and Research Society LTM Medical College |
Approved |
| Institutional Ethics Committee, Sri Ramachandra University, Chennai |
Approved |
| Sri Venkateshwara Hospital Institutional Ethics Committee |
Approved |
| Sri Venkateshwara Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Anxiety Disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Arm 1 |
Subjects will be administered with Clonazepam 0.25 mg tablet once daily for 8 weeks |
| Intervention |
Arm 2 |
Subjects will be administered with fixed dose combination of Clonazepam 0.25 mg + Propranolol 10 mg tablet once daily for 8 weeks |
| Intervention |
Arm 3 |
Subjects will be administered with fixed dose combination of Clonazepam 0.25 mg + Propranolol 20 mg tablet once daily for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between 18- 65 years of age
2. Patients with established diagnosis of Anxiety (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM V)
3. Total Hamilton Rating Scale for Anxiety (HAM-A) score ≥17
4. CGI-S score greater than 4 in the week prior to inclusion of the study.
5. Willingness and able to give informed consent and comply with requirements for participation in the study |
|
| ExclusionCriteria |
| Details |
1. Pregnancy and/or lactation
2. Patients with a history of mania, schizophrenia, seizures, narrow angle glaucoma, pre-existing CNS depression or coma, respiratory depression, acute pulmonary insufficiency, hyper thyroidism, myasthenia gravis, diabetes mellitus, sleep apnoea, chronic pulmonary insufficiency and/or muscle weakness
3. Patients with suicidal tendencies
4. Patients operating hazardous machinery, including automobiles
5. Patients with renal and/or hepatic insufficiency
6. Patients who have a history of hypersensitivity to clonazepam and/or Propranolol and/or any components of the formulations
7. Patients with any other serious concurrent illness or malignancy
8. Patients with continuing history of alcohol and/or drug abuse
9. Participation in another clinical trial in the past 3 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the score on the Hamilton Rating Scale for Anxiety (HAM-A) at the end of treatment(8th week) as compared to baseline |
Baseline to week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of patients having a 50% reduction in the HAM-A total score at the end of the study (8th week) as compared to baseline
|
Baseline to week 8
|
| Degree of improvement in the mean CGI-S (global severity of the CGI scale) score at the end of study (8th week) as compared to baseline. |
Baseline to week 8 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "149"
Final Enrollment numbers achieved (India)="149" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
15/01/2018 |
| Date of Study Completion (India) |
13/07/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is A randomized, double-blind, multicentric, active controlled Phase IV clinical study to evaluate the Safety, Efficacy and Tolerability of fixed dose combination of Clonazepam 0.25 mg and Propranolol 10/20 mg in patients with anxiety disorders. The total sample size of trial is 150. The total duration of study is 8 week.
The clinical efficacy will be tested by the following parameter (Primary Outcome) ï‚· Change in the score on the Hamilton Rating Scale for Anxiety (HAM-A) at the end of treatment(8th week) as compared to baseline
The clinical safety and efficacy will be tested by the following parameter ï‚· Percentage of patients having a 50% reduction in the HAM-A total score at the end of the study (8th week) as compared to baseline ï‚· Degree of improvement in the mean CGI-S (global severity of the CGI scale) score at the end of study (8th week) as compared to baseline. ï‚· Safety and tolerability of the study drug will be assessed by monitoring vital signs, physical examination, ECG, clinically significant changes in laboratory parameters and adverse events
The safety of the drug(s) during the study will be monitored by adverse effect monitoring during patient visits or through telephonic information in between visits, & laboratory investigations. The compliance will also be monitored by pill-counting the left over medication during patient visits. |