| CTRI Number |
CTRI/2020/09/027603 [Registered on: 04/09/2020] Trial Registered Prospectively |
| Last Modified On: |
03/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Post Marketing Surveillance Study to Evaluate the Safety, Tolerability and Efficacy of FDC of Pregabalin 75 mg
and Nortriptyline 10 mg Tablets in Adult Patients for the treatment of Neuropathic Pain |
|
Scientific Title of Study
|
An Open Label, Prospective, Non-comparative,Multicentric,
Single Arm, Active Post Marketing Surveillance Study to Evaluate the Safety, Tolerability and Efficacy of FDC of Pregabalin 75 mg
and Nortriptyline 10 mg Tablets in Adult Patients for the treatment of Neuropathic Pain. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr PK Sharma |
| Designation |
Principal Investigator |
| Affiliation |
Maharaja Agrasen Hospital |
| Address |
OPD Room No. 107, Basement, Maharaja Agrasen Superspecialty Hospital,
Vidhyadhar Nagar Marg, Sector 7, Central Spine, Vidyadhar Nagar, Jaipur, Rajasthan 302023
Jaipur
RAJASTHAN
302023
India |
| Phone |
9983995050 |
| Fax |
|
| Email |
doctorpksharma.mah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Rajauria |
| Designation |
Medical Writer |
| Affiliation |
Universal Healthcare Research Solutions |
| Address |
Universal Healthcare Research Solution
602, 6th floor, Akanksha Building, Shiv Vallabh Road, Ashok Van, Dahisar (E), Mumbai -400068
Mumbai (Suburban)
MAHARASHTRA
400068
India |
| Phone |
8209179682 |
| Fax |
|
| Email |
gauravrajauria1995@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Rajauria |
| Designation |
Medical Writer |
| Affiliation |
Universal Healthcare Research Solutions |
| Address |
Universal Healthcare Research Solution
602, 6th floor, Akanksha Building, Shiv Vallabh Road, Ashok Van, Dahisar (E), Mumbai -400068
Mumbai (Suburban)
MAHARASHTRA
400068
India |
| Phone |
8209179682 |
| Fax |
|
| Email |
gauravrajauria1985@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aeon Formulations Pvt. Ltd.
R. S. No. 512/2 & 514, No. 152/7 Thirubuvanaipalayam, Mannadipet, Commune, Puducherry-605107, India |
|
|
Primary Sponsor
|
| Name |
Aeon Formulations Pvt Ltd |
| Address |
R. S. No. 512/2 & 514, No. 152/7
Thirubuvanaipalayam, Mannadipet,
Commune, Puducherry-605107, India |
| 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 PK Sharma |
Maharaja Agrasen Superspecialty Hospital |
Vidhyadhar Nagar Marg, Sector 7, Central Spine, Vidyadhar Nagar, Jaipur, Rajasthan 302023
Jaipur
RAJASTHAN |
9983995050
doctorpksharma.mah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Maharaja Agrasen Superspecialty Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M792||Neuralgia and neuritis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Pregabalin 75 mg and Nortriptyline 10 mg Tablets |
Diagnosed with neuropathic pain and who require treatment with FDC of Pregabalin 75 mg and Nortriptyline 10 mg Tablets as part of their routine treatment regimen
Route: Oral Tablets
Duration: 3 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults male or female patients aged 18 to 65 years (both inclusive), diagnosed with neuropathic pain and who require treatment with FDC of Pregabalin 75 mg and Nortriptyline 10 mg Tablets as part of their routine treatment regimen |
|
| ExclusionCriteria |
| Details |
1. Patients with known hypersensitivity to Pregabalin / Nortriptyline.
2. Females of childbearing age not using effective contraception/nursing & pregnant females.
3. Patients predisposed to Thrombocytopenia / liver dysfunction / renal impairment. 4. Patients with known history of myocardial infarction (MI) / cardiac arrhythmia. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients reporting incidences of AE and/or SAE during the study and their assessment in respect to intensity, duration, pattern and causal relationship to the study medication. |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Numeric Rating Scale (NRS) from baseline to end of the study. |
3 Months |
|
|
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)
|
08/09/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This trial is an open-label, prospective, non-comparative, multicentric, single-arm, active post-marketing surveillance study to evaluate the safety, tolerability and efficacy of FDC of Pregabalin 75 mg and Nortriptyline 10 mg Tablets in Adult Patients for the treatment of neuropathic pain. All the patients being prescribed the medication will be enrolled in the study. As this is an active post-marketing surveillance study to evaluate the safety, tolerability and efficacy of the drug manufactured by Aeon Formulations Pvt. Ltd, free samples will be given to all the patients to ensure that the patients do not change the test product being used. Follow up visits will be done on day 45±7 and day 90±7 (Final Visit) of treatment to assess safety, tolerability and efficacy |