| CTRI Number |
CTRI/2020/06/026111 [Registered on: 24/06/2020] Trial Registered Prospectively |
| Last Modified On: |
28/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Post Marketing Surveillance Study (PMS) to generate safety and efficacy data of Desvenlafaxine and Clonazepam tablets |
|
Scientific Title of Study
|
Prescriber Based, Post Marketing Surveillance Study (PMS) to generate safety and efficacy data of Desvenlafaxine and Clonazepam tablets |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Akums/PMS/Desven_Clonaz/082019 Version 00, Dated 01.08.2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudeep Kumar Patra |
| Designation |
Head Operations |
| Affiliation |
CRO PHARMATRENDZ PRIVATE LIMITED |
| Address |
PLOT NUMBER F 29
Near Radhakrushna Temple
BJB NAGAR
BHUBANESWAR
PLOT NUMBER F 29
Near Radhakrushna Temple
BJB NAGAR
BHUBANESWAR
Khordha
ORISSA
751014
India |
| Phone |
9861268508 |
| Fax |
|
| Email |
sudeep@pharmatrendz.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saiprasanna Behera |
| Designation |
Director |
| Affiliation |
CRO PHARMATRENDZ PRIVATE LIMITED |
| Address |
PLOT NUMBER F 29
Near Radhakrushna Temple
BJB NAGAR
BHUBANESWAR
PLOT NUMBER F 29
Near Radhakrushna Temple
BJB NAGAR
BHUBANESWAR
Khordha
ORISSA
751014
India |
| Phone |
9861252518 |
| Fax |
|
| Email |
drsai@pharmatrendz.com |
|
Details of Contact Person
Public Query
|
| Name |
Mamta Sharma |
| Designation |
Sr Manager DRA |
| Affiliation |
Akums Drugs and Pharmaceuticals Limited |
| Address |
#304 Mohan Place
Local Shopping Complex
Block C
Saraswati Vihar
New Delhi
#304 Mohan Place
Local Shopping Complex
Block C
Saraswati Vihar
New Delhi
110034
New Delhi
DELHI
110034
India |
| Phone |
9937444200 |
| Fax |
|
| Email |
sharmamamta0617@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akums Drugs and Pharmaceuticals Limited |
|
|
Primary Sponsor
|
| Name |
Akums Drugs and Pharmaceuticals Limited |
| Address |
#304 Mohan Place
Local Shopping Complex
Block C
Saraswati Vihar
New Delhi
110034
|
| 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 Amrit Pattojoshi |
Hi Tech Medical College & Hospital |
Health Park, Pandara, Bhubaneswar-751025.
Odisha
Khordha
ORISSA |
7008690566
dramritpattojoshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sparsh Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F339||Major depressive disorder, recurrent, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex of age 18 to 60 years [both inclusive]
2. Willing to give written informed consent
3. All patients clinically manifesting with symptoms of major depressive disorder
|
|
| ExclusionCriteria |
| Details |
1) Patients known, or thought to be hypersensitivity to study drug
2) History of auto-immune disease
3) Concurrent use of corticosteroids
4) Any medication or indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion
5) Participation in other clinical trials the last three months and during study participation
6) Patients with history of epilepsy, or those at risk for seizures or taking seizure drugs
7) Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control
8) Patients with galactose or fructose intolerance
9) Patients with severe renal impairment, including those receiving dialysis.
10) Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
11) Patients with preexisting gallbladder disease
12) Active peptic ulcer disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of this PMS is to evaluate safety and tolerability of this FDC in treatment of major depressive disorder in the actual field conditions of use. |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objective of this PMS is to evaluate efficacy of this FDC in treatment of major depressive disorder in the actual field conditions of use. |
4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
26/06/2020 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The fixed dose combination oral tablet of
Desvenlafaxine and Clonazepam is being marketed in India for the treatment of major depressive disorder.
The primary objective of this PMS is to evaluate
safety and tolerability of this FDC in treatment of major depressive disorder in the actual field
conditions of use. The secondary objective of this PMS is to evaluate efficacy of this FDC in treatment of major depressive disorder in the actual field
conditions of use.
All patients
clinically manifesting with symptoms of major depressive disorder and who have been prescribed Desvenlafaxine and Clonazepam TABLET in the recommended doses will be assessed for safety & efficacy.
Patients will usually be called for follow-up on the day convenient to
them and
will be judged on the bases of enquiry & clinician impression.
|