| CTRI Number |
CTRI/2022/02/040403 [Registered on: 18/02/2022] Trial Registered Prospectively |
| Last Modified On: |
04/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial of Tapentadol Nasal Spray Phase-IV |
|
Scientific Title of Study
|
A Multicentric, Open-label, Single-arm, Non-comparative, Clinical Trial to Evaluate
Safety and Efficacy of Tapentadol Nasal Spray in Patients with Moderate to Severe Pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/TAPE/PAIN/20/04_01 version 2.0 Dated 27/10/2020 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Ram Gupta |
| Designation |
Assistant General Manager, Clinical Research Group |
| Affiliation |
TorrentPharmaceuticals Limited |
| Address |
Torrent Pharmaceuticals Limited
Research Centre, Village Bhat, Dist. Gandhinagar
Gujarat, India
Gandhinagar
GUJARAT
382428
India |
| Phone |
07923969100-197 |
| Fax |
|
| Email |
ramgupta@torrentpharma.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Ram Gupta |
| Designation |
Assistant General Manager, Clinical Research Group |
| Affiliation |
TorrentPharmaceuticals Limited |
| Address |
Torrent Pharmaceuticals Limited
Research Centre, Village Bhat, Dist. Gandhinagar
Gujarat, India
Gandhinagar
GUJARAT
382428
India |
| Phone |
07923969100-197 |
| Fax |
|
| Email |
ramgupta@torrentpharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Ram Gupta |
| Designation |
Assistant General Manager, Clinical Research Group |
| Affiliation |
TorrentPharmaceuticals Limited |
| Address |
Torrent Pharmaceuticals Limited
Research Centre, Village Bhat, Dist. Gandhinagar
Gujarat, India
Gandhinagar
GUJARAT
382428
India |
| Phone |
07923969100-197 |
| Fax |
|
| Email |
ramgupta@torrentpharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Ltd Torrent Research Centre Village Bhat Tal Dist Gandhinagar Gujarat India, pincode-382428 |
|
|
Primary Sponsor
|
| Name |
TORRENT PHARMACEUTICALS LIMITED |
| Address |
TORRENT RESEARCH CENTRE
VILLAGE: BHAT 382 428
DIST. GANDHINAGAR, (GUJARAT) INDIA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahakalkar Chandrashekhar Chintamanrao |
Acharya Vinoba Bhave Rural Hospital |
Jawaharlal Nehru Medical College, Datta Meghe Institute
of Medical Sciences (DU), Sawangi (M), Wardha- 442004, Maharashtra
Wardha
MAHARASHTRA |
9822369277
cmahakalkar@rediffmail.com |
| Dr Praveen Talawar |
All India Institute of Medical Sciences |
Rishikesh Virbhadra Marg, Pashulok,
Rishikesh - 249203
Hardwar
UTTARANCHAL |
9654162941
9654162941
praveenrt64@gmail.com |
| Dr Yash Sanghavi |
Anand Surgical Hospital Private Limited, |
Memco Cross RD, Naroda Road, Naroda, Ahmedabad
Ahmadabad
GUJARAT |
8238656960
dryashsanghavi.research@gmail.com |
| Dr Valsa Abraham |
Christian Medical &Hospital |
Department of Anaesthesia, Christian Medical &Hospital, Brown Road, Ludhiana, Punjab
Ludhiana
PUNJAB |
911612115381
911612600270
contact@cmcludhiana.in |
| Dr Chandan Kumar |
Department of Orthopedics, GSVM Medical College |
Department of Orthopedics, GSVM Medical College, Swaroop Nagar, Kanpur-208002, UP
Kanpur Nagar
UTTAR PRADESH |
915122535483
9105122535881
ck_80@rediffmail.com |
| Dr Suraj Pattnayak |
Government Medical College & Govt. General Hospital (Old RIMSGGH) Srikakulam |
Government Medical College & Govt. General Hospital (Old RIMSGGH)
Srikakulam-532001, Andhra Pradesh India
Srikakulam
ANDHRA PRADESH |
91-8942-279033
91-8942-279033
gghsrikakulam@gmail.com |
| DrJadhav Jagdish Shankarrao |
Lifepoint Multispecialty Hospital Maharashtra |
Lifepoint Multispecialty Hospital,145/1,Mumbai Bangalore Highway, Near Hotel
Sayaji, Wakad, Pune-411057, Maharashtra
Pune
MAHARASHTRA |
7290047048
7290047048
enquiry@lifepointhospital.in |
| Dr Sushil Mankar |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital,
Digdoh Hills ,Hingna Road, Nagpur-440019
Nagpur
MAHARASHTRA |
07104665000
07104244904
drshmankar@gmail.com |
| Dr Pratik Vinchi |
Parth Hospital Naroda, Gujarat |
E/405-4, 407-411, Fourth floor Galaxy Arcade, Near Galaxy Cinema, Naroda, Gujarat 382330, India
Ahmadabad
GUJARAT |
9909032354
pratikvinchhi.cr@gmail.com |
| DrPrashantChandrakantKamble |
Seth G S Medical College & KEM Hospital, |
parel mumbai
Mumbai
MAHARASHTRA |
9930833434
9930833434
dr.prashantkamble@gmail.com |
| DrJaimin Vashi |
Shubham Multispecialty Hospital, ABC Complex |
Near Rabari Colony Cross Road.
Amraiwadi, Ahmedabad-380026
Ahmadabad
GUJARAT |
9824025864
079-22870709
jaiminvashi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee, GSVM Medical College |
Approved |
| Institute Ethics Committee AIIMS, Rishikesh |
Submittted/Under Review |
| Institutional Ethics Committee (I.EC.II) Parel, Mumbai |
Submittted/Under Review |
| Institutional Ethics Committee Christian Medical &Hospital Ludhiana Punjab |
Submittted/Under Review |
| Institutional Ethics Committee NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, |
Approved |
| Institutional Ethics Committee Sawangi, Wardha Maharashtra |
Submittted/Under Review |
| Institutional Ethics CommitteeGovernement Medical collage and general hospital srikakulam |
Approved |
| Kanoria Ethics Committee Gandhinagar Gujarat |
Submittted/Under Review |
| LPR Ethics Committee Lifepoint Multispecialty hospital |
Approved |
| Parth Institutional Ethics Committee Naroda Ahmedabad |
Approved |
| Shubham Institutional Ethics Committee ahmedbad |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R52||Pain, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE as study is single arm study |
Not Applicable |
| Intervention |
Tapentadol HCl nasal spray
|
dose-45
mg (one spray in each nostril) / 22.5 mg (one spray in single nostril)
Frequency:Eligible patients will be administered tapentadol nasal spray
45mg (one spray in each nostril). Additional one dose of tapentadol nasal spray 45 mg may
be administered after 1 hour of first dose as per Investigator discretion. Subsequently, the
frequency of tapentadol nasal spray administration will be every 4-6 hours. Dose will be
adjusted as per Investigator discretion.
Route of administration:Intra- nasal
Duration of therapy:Treatment shall be continued for duration deemed
necessary by Investigator, considering patients need to continue on tapentadol nasal spray for analgesia. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female subjects aged 18-65 years, both inclusive.
2. After weaning of anaesthesia post-surgery, patients having pain intensity score ≥ 4 on an
11-point (0 to 10) Numeric Pain Rating Scale (NPRS).
3. Patients having physical status of I-II according to American Society of
Anaesthesiologists (ASA) classification.
4. Patient willing to give written informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Patients with a history of hypersensitivity to tapentadol or any of the excipients.
2. Patients who have taken any medication by intranasal route within the 72 hours prior to
enrolment.
3. 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.
4. 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.
5. Patient having history of clinically significant medical illness in past 3 months, which may compromise the patients’ safety or study outcome.
6. History of alcohol, other opioids, or illicit drug abuse within past 6 months and chronic use of any opioids for any disease in past 1 month.
7. Pregnant or lactating women.
8. In the opinion of the Investigator, patient is either unable to cooperate or unlikely to
adhere with any study procedures.
9. Patients who have participated in any other investigational drug trial within the past four
weeks prior to screening. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety: Incidence of adverse events |
At the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Efficacy
1) Proportion of patients achieving 30% reduction in pain
2) Proportion of patients achieving 50% reduction in pain |
at the end of study |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2022 |
| 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="3"
Months="0"
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
Modification(s)
|
Tapentadol is
centrally acting analgesic with dual mechanisms of action: µ-opioid receptor
agonism and norepinephrine reuptake inhibition. It is approved as immediate
release tablet (50mg, 75 mg, 100mg) and extended release tablet (50mg, 100mg,
150mg, 200mg, 250mg) in India for moderate to severe acute pain. Efficacy
and safety of tapentadol nasal spray has been established in phase-III,
multi-centric, randomized, open-label clinical trial. The tapentadol nasal
spray is approved by the CDSCO for the treatment of moderate to severe
post-operative pain. This phase 4 clinical trial is a Multicentric, Open-label,
Single-arm, Non-comparative, Clinical Trial to Evaluate Safety and Efficacy of
Tapentadol Nasal Spray in Patients with Moderate to Severe Pain.
|