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CTRI Number  CTRI/2024/05/067264 [Registered on: 14/05/2024] Trial Registered Prospectively
Last Modified On: 13/05/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective Study 
Study Design  Other 
Public Title of Study   Affects of Tapentadol nasal spray in back ache 
Scientific Title of Study   Retrospective observational study to assess efficacy of Tapentadol nasal spray in moderate to severe back ache patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shobhan Mandal  
Designation  Principal Investigator 
Affiliation  D Y Patil Medical College and Hospital 
Address  Department of Orthopedics, D Y Patil Medical College and Hospital, Nerul, Navi Mumbai, Maharashtra - 400706

Mumbai
MAHARASHTRA
400706
India 
Phone  9987337413  
Fax    
Email  shobhanmandal@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Shobhan Mandal  
Designation  Principal Investigator 
Affiliation  D Y Patil Medical College and Hospital 
Address  Department of Orthopedics, D Y Patil Medical College and Hospital, Nerul, Navi Mumbai, Maharashtra - 400706

Mumbai
MAHARASHTRA
400706
India 
Phone  9987337413  
Fax    
Email  shobhanmandal@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Shobhan Mandal  
Designation  Principal Investigator 
Affiliation  D Y Patil Medical College and Hospital 
Address  Department of Orthopedics, D Y Patil Medical College and Hospital, Nerul, Navi Mumbai, Maharashtra - 400706

Mumbai
MAHARASHTRA
400706
India 
Phone  9987337413  
Fax    
Email  shobhanmandal@yahoo.co.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Shobhan Mandal 
Address  Department of Orthopedics, D. Y. Patil Medical college and Hospital, Nerul, Navi-Mumbai, Maharashtra - 400706 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shobhan Mandal  D Y Patil Medical College and Hospital  Department of Orthopedics, 2nd Floor, D Y Patil Medical College and Hospital, Nerul, Navi Mumbai, Maharashtra - 400706
Mumbai
MAHARASHTRA 		 9987337413

shobhanmandal@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Patients must have a medical history and physical and neurological examinations that support a clinical diagnosis of acute/ chronic low back pain that is felt down to the lower leg below the knee.
2 Patients must be able to appropriately verbalize pain characteristics and to complete all protocol required measurements/assessments without assistance. Patients must be medically stable on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening 
 
ExclusionCriteria 
Details  1 History of hypersensitivity to Tapentadol.
2 Active or suspected gastrointestinal ulcers, bleeding, or motility disorders within the past 6 months prior to screening.
3 Recent intranasal medication within the 72 hours preceding randomization.
4 Analgesic administration post-operatively before enrolment.
5 Concurrent use of tricyclic antidepressants, selective serotonin reuptake inhibitors, selective noradrenaline reuptake inhibitors, anticonvulsants, neuroleptics, triptans, steroids, monoamine oxidase inhibitors, or drugs with potential to lower seizure threshold in the 4 weeks prior to enrolment.
6 History of seizures.
7 Mild to moderate traumatic brain injury, stroke, or brain neoplasm within the past year or severe traumatic brain injury within the last 15 days.
8 Clinically significant ECG abnormalities or QTC greater than or equal to 450 msec for males and greater than or equal to 470 msec for females at screening.
9 Pregnancy or lactation. Bronchial Asthma and COPD 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in pain severity based on numeric pain rating scale value  Day 1 and Day 3 
 
Secondary Outcome  
Outcome  TimePoints 
1 Need for rescue medicine (i.v. Paracetamol)
2 Change in the Global Sleep Quality Score
3 Safety assessment in terms of adverse events like (Nausea, vomiting, dizziness and allergic reactions post medication) 		 Day 1 and Day 3 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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   N/A 
Date of First Enrollment (India)   30/05/2024 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a retrospective, observational, real-world evidence study from Electronic Medical Records to evaluate the effectiveness and tolerability of Tapentadol (Tapease NS) in patients with Low Back Pain at D Y Patil Medical College and Hospital, Mumbai, Maharashtra.  
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