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CTRI Number  CTRI/2024/09/074460 [Registered on: 27/09/2024] Trial Registered Prospectively
Last Modified On: 19/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   To assess the clinical safety and effectiveness of Tapentadol nasal spray and tramadol and acetaminophen (TRAM/APAP) as Post–operative patients in TAP-IT Study 
Scientific Title of Study   Investigator –initiated, Case Control analyses to assess the clinical safety and effectiveness of Tapentadol nasal spray and tramadol and acetaminophen (TRAM/APAP) as Post –operative strategy (TAP-IT) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sunil Shetty 
Designation  MS Orthopedic 
Affiliation  DY Patil  
Address  DY Patil University School of Medicine Healthcare D wing Sector 5 Dept. of Orthopedic room no. 4 Nerul Navi Mumbai 400706

Mumbai
MAHARASHTRA
400706
India 
Phone  8424028164  
Fax    
Email  iec.dyphrc@dypatil.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunil Shetty 
Designation  MS Orthopedic 
Affiliation  DY Patil  
Address  DY Patil University School of Medicine Healthcare D wing Sector 5 Dept. of Orthopedic, room no. 4 Nerul Navi Mumbai 400706

Mumbai
MAHARASHTRA
400706
India 
Phone  8424028164  
Fax    
Email  iec.dyphrc@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Dr Krishnaprasad K 
Designation  Medical Head 
Affiliation  Torrent Pharma Ltd 
Address  Torrent House Off Ashram Road Ahmedabad dept. of medicine room no.7 380009 Gujarat India

Ahmadabad
GUJARAT
380009
India 
Phone  9820806811  
Fax    
Email  krishnaprasadkorukonda@torrentpharma.com  
 
Source of Monetary or Material Support  
Torrent Pharmaceuticals Ltd Torrent House Off Ashram Road Ahmedabad 380009 Gujarat India 
 
Primary Sponsor  
Name  Torrent Pharmaceuticals Ltd 
Address  Torrent House Off Ashram Road Ahmedabad 380009 Gujarat India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Sunil Shetty  DY Patil University  DY Patil University School of medicine D-wing Sec-05, Dept. of orthopedic, room no. 4 Nerul Navi Mumbai 400705
Mumbai
MAHARASHTRA 		 9821288076

iec.dyphrc@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
D Y Patil  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S381||Crushing injury of abdomen, lowerback, and pelvis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Tapentadol HCl  45 mg : one spray (22.5 mg/100µL) in each nostril 22.5 mg : one spray (22.5 mg/100µL) in a single nostril Formulation: Nasal spray 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Male or female subjects aged 18-65 years both inclusive
Clinical cases of Hip surgeries Knee surgeries, and major surgeries
After weaning of anesthesia post-surgery, patients having pain intensity score greater than or equal to 4 on an 11-point (0 to 10) Numeric Pain Rating Scale (NPRS) 
 
ExclusionCriteria 
Details  Patients with a history of hypersensitivity to tapentadol or any of the excipients
Patients currently being treated with tricyclic antidepressants selective serotonin
reuptake inhibitors selective noradrenaline reuptake inhibitors anticonvulsants
neuroleptics triptans monoamine oxidase inhibitors steroids or other drugs that has
potential to reduce the seizure threshold within the past 4 weeks prior to screening
Patients with history of impaired pulmonary function (significant respiratory depression
acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence
of resuscitative equipment) severe renal or hepatic impairment suspected paralytic ileus
or head injury
Patient having history of clinically significant medical illness in past 3 months which
may compromise the patients safety or study outcome
Pregnant or lactating women.
In the opinion of the Investigator patient is either unable to cooperate or unlikely to
adhere with any study procedures
Patients who have participated in any other investigational drug trial within the past four
weeks prior to screening 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Numeric Pain Rating Score change at Day 5
Responder rate (greater than or equal to 50 percent drop in NRS) at Day 5
 		 at day 5 
 
Secondary Outcome  
Outcome  TimePoints 
Patient global assessment at 24 hours after treatment initiation & at the end of study

Clinical Global Impression Efficacy Index after 24 hours after treatment initiation
and at the end of study day 5 		 at day 5 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   03/10/2024 
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="3"
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   Title of study: Investigator –initiated, Case Control analyses to assess the clinical safety and effectiveness of Tapentadol nasal spray and tramadol and acetaminophen (TRAM/APAP) as Post –operative strategy (TAP-IT) 
Description of Investigational Product 
Drug Details       Test Product 
Generic Name:   Tapentadol HCl 
Strength:            45 mg : one spray (22.5 mg/100µL) in each nostril 
                           22.5 mg : one spray (22.5 mg/100µL) in single nostril 
Formulation:       Nasal spray 
Manufactured by/for:  Torrent Pharmaceuticals Ltd., India 
Study center:       DY Patil University School of Medicine Healthcare D-wing, Sector-5,Nerul, Navi Mumbai – 400706
Introduction and background: Tapentadol is a centrally acting synthetic analgesic. It is a mu-opioid receptor (µOR) agonist and a norepinephrine reuptake inhibitor (NRI). Tapentadol nasal spray is already approved by Indian regulatory agency, CDSCO for treatment of moderated to severe post-operative pain in hospital admitted patients undergoing any major joint or spine surgeries
Centrally acting tapentadol delivered intranasally offers direct nasal-brain connect that regulates or modulates central sensitization to offer quick onset of action while pre-empting the complications associated as frequent breakthrough pain requiring rescue medication.
Study objective: To evaluate efficacy and safety of tapentadol nasal spray in comparison to Tramadol /Acetaminophen in Post-operative settings for the management of Moderate or Severe pain. 
Study design: Post approval, Observational, longitudinal, case control, single centre, open label, clinical study. 
Number of planned subjects: 110 
Dosage and administration:
Eligible patients will be administered tapentadol nasal spray 22.5 mg (one spray in each nostril, 45 mg) every 6 hours with minimum of three dosages in a day. 
 Daily total dose greater than 315 mg on the first day of therapy and 270 mg on subsequent days is not recommended. Tramadol37.5/Acetaminophen325 will be administered as 1 to 2 tablets stat dose every 6 hours with a minimum of three dosages in a day 
 Eligibility Criteria: Participants meeting all of the following inclusion and none of the following exclusion criteria shall be included in the study. 
Inclusion criteria: 
1. Male or female subjects aged 18-65 years, both inclusive.
 2. Clinical cases of Hip surgeries, Knee surgeries and major surgeries 
3. After weaning of anesthesia post-surgery, patients having pain intensity score ≥ 4 on an 11-point (0 to 10) Numeric Pain Rating Scale (NPRS). 
Exclusion criteria: 
1. Patients with a history of hypersensitivity to tapentadol or any of the excipients. 
2. Patients currently being treated with tricyclic antidepressants, selective serotonin reuptake inhibitors, selective noradrenaline reuptake inhibitors, anticonvulsants, neuroleptics, triptans, monoamine oxidase inhibitors, steroids or other drugs that has potential to reduce the seizure threshold within the past 4 weeks prior to screening. 
3. Patients with history of impaired pulmonary function (significant respiratory depression, acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment), severe renal or hepatic impairment, suspected paralytic ileus or head injury. 
4. Patient having history of clinically significant medical illness in past 3 months, which may compromise the patients’ safety or study outcome. 
5. Pregnant or lactating women. 
 6. In the opinion of the Investigator, patient is either unable to cooperate or unlikely to adhere with any study procedures. 
7. Patients who have participated in any other investigational drug trial within the past four weeks prior to screening. 
Study schedule: 
Screening phase : Day -7 to Day -1 for cases of Hip surgeries, Knee surgeries and major surgeries requiring General or Spinal anesthesia Enrolment Day: Day 0* 
Treatment phase & end of study: Treatment with TNS or TRAM/APAP in either arm shall be initiated in post –operative settings at 48 to 72 h after Major surgery with weaning off the anesthesia for duration of 5 days. 
 End of study assessments will be performed on the day of study drug discontinuation. 
 *After weaning of anaesthesia post-surgery, tapentadol nasal spray or TRAM/APAP will be administered to patients with NPRS ≥ 4. 
Note: pain intensity based on NPRS: 0= none, 1-3=mild, 4-6=moderate, 7-10= severe 
Outcome measures: 
Primary Endpoints: Numeric Pain Rating Score change at Day 5
                               Responder rate (>/=50% drop in NRS) at Day 5  
Secondary Endpoints: Patient global assessment at 24 hours after treatment initiation and at the end of study
Clinical Global Impression: Efficacy Index after 24 hours after treatment initiation and at the end of study
 
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