| CTRI Number |
CTRI/2021/09/036458 [Registered on: 13/09/2021] Trial Registered Prospectively |
| Last Modified On: |
08/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to assess the safety of combination of Pregabalin 75 mg and Nortriptyline 10 mg Tablets available in market. |
|
Scientific Title of Study
|
“An Open Label, Prospective, Multicentric, Single Arm, Active Post Marketing Surveillance Study to Evaluate the Safety and Efficacy of FDC of Pregabalin 75 mg plus Nortriptyline 10 mg Tablets in Adult Patients for the Treatment of Neuropathic Pain.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRPL/CT/21/017 |
Protocol Number |
| Version No. 00 & Dated Jul 28, 2021 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajasekhara Reddy Tamma |
| Designation |
Managing Director |
| Affiliation |
Clinwave Research Pvt. Ltd. |
| Address |
# H. No.: 4-32-41/13, Plot No.: 38,
Kamala Prasanna Nagar,
Near Ramalayam Temple,
Kukatpally, Hyderabad.
Hyderabad
TELANGANA
500072
India |
| Phone |
7989233379 |
| Fax |
|
| Email |
dr.sekhar@clinwave.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajasekhara Reddy Tamma |
| Designation |
Managing Director |
| Affiliation |
Clinwave Research Pvt. Ltd. |
| Address |
# H. No.: 4-32-41/13, Plot No.: 38,
Kamala Prasanna Nagar,
Near Ramalayam Temple,
Kukatpally, Hyderabad.
Hyderabad
TELANGANA
500072
India |
| Phone |
7989233379 |
| Fax |
|
| Email |
dr.sekhar@clinwave.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Surender Kumar Arora |
| Designation |
President - Drug Regulatory Affairs |
| Affiliation |
Synokem Pharmaceuticals Ltd. |
| Address |
Synokem Pharmaceuticals Ltd.,
14/486, Sunder Vihar,
Outer Ring Road, Paschim Vihar,
New Delhi.
New Delhi
DELHI
110087
India |
| Phone |
9811015684 |
| Fax |
|
| Email |
ska@synokempharma.com |
|
|
Source of Monetary or Material Support
|
| Synokem Pharmaceuticals Ltd.,
14/486, Sunder Vihar,
Outer Ring Road, Paschim Vihar,
New Delhi-110087, India. |
|
|
Primary Sponsor
|
| Name |
Synokem Pharmaceuticals Ltd |
| Address |
14/486, Sunder Vihar,
Outer Ring Road, Paschim Vihar, New Delhi-110087, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prajapati Vipulkumar Bachubhai |
Ananta Multispeciality Hospital |
Research Room, 4th Floor (416-418), Centrepoint, Opp. Vrundavan Heights, Vandemataram City to Savvy Swaraj Road, Chenpur, Gota, Ahmedabad-382470.
Ahmadabad
GUJARAT |
9909912551
prajapativipul1983@gmail.com |
| Dr G Prathyusha |
Anu Hospitals |
Department of Clinical Research, Kovelamudivari Street, Suryaraopet, Vijayawada-520002.
Krishna
ANDHRA PRADESH |
9963674288
drctresearch@gmail.com |
| Dr Hrishikesh Bora |
Down Town Hospital |
Research Room,
Dispur, G.S. Road, Guwahati-781006.
Kamrup
ASSAM |
9864044323
hris_11@yahoo.co.in |
| Dr Peddi Sirisha |
Gandhi Medical College and Hospital |
In Patient Block, 3rd Floor,
Department of General Medicine,
Musheerabad, Secunderabad-500003.
Hyderabad
TELANGANA |
9701859566
sirishabhaskar.sirisha@gmail.com |
| Dr Jitendra Singh Kushwaha |
GSVM Medical College |
Post Graduate Department of Medicine,
Swaroop Nagar, Kanpur-208002.
Kanpur Nagar
UTTAR PRADESH |
9415040752
drjskushwaha@gmail.com |
| Dr Rajnish Kumar Singh |
Pushpanjali Hospital and Research Centre Pvt. Ltd. |
Department of Clinical Research,
Pushpanjali Palace, Near Delhi Gate,
Agra-282002.
Agra
UTTAR PRADESH |
7060009765
rksinghdr56@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee, Down Town Hospital |
Approved |
| Ethics Committee, GSVM Medical College |
Approved |
| Institutional Ethics Committee, Anu Hospitals |
Approved |
| Institutional Ethics Committee, Gandhi Medical College / Hospital |
Approved |
| Pushpanjali Hospital Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee, Ananta Multispeciality 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 |
| Intervention |
FDC of Pregabalin 75 mg plus Nortriptyline 10 mg Tablets |
Patients will be advised to take one tablet once a day orally every night at bedtime for 90 days. |
| 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 aged 18 to 65 years (both inclusive), diagnosed with neuropathic pain and who require treatment with FDC of Pregabalin 75 mg plus Nortriptyline 10 mg Tablets as part of their routine treatment regimen. |
|
| ExclusionCriteria |
| Details |
1. Patients with known hypersensitivity to Pregabalin / Nortriptyline.
2. Females of child bearing 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
|
Open Label |
|
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. |
At Day 45±5 and Day 90±5. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Numeric Rating Scale (NRS) from baseline to end of the study. |
At Day 1, Day 45 and Day 90 |
| Consumption of rescue medication (number of other analgesic tablets consumed). |
At Day 45 and Day 90 |
| Overall safety and efficacy of the study medication at the end of the study. |
At Day 90 |
|
|
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)
|
15/09/2021 |
| Date of Study Completion (India) |
26/02/2022 |
| 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)?
Response - NO
|
|
Brief Summary
|
This
trial is an open label, prospective, multicentric, single arm, active post
marketing surveillance study to evaluate the safety and efficacy of FDC of Pregabalin 75 mg plus
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. Patients will be
advised to take one tablet once a day orally every night at bedtime for 90
days. Follow up visits will be done on day 45±5 and day 90±5 (Final Visit) of
treatment to assess safety and efficacy. |