| CTRI Number |
CTRI/2023/11/060049 [Registered on: 21/11/2023] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Polmacoxib and Paracetamol combination effectiveness in pain relief after dental extraction |
|
Scientific Title of Study
|
A Prospective, Multicentric, Double blind, Randomized, Active Controlled, Parallel
Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Polmacoxib
2mg and Paracetamol 325mg compared to Fixed Dose Combination of Etoricoxib 60mg
and Paracetamol 325mg in Adults with Acute Pain due to Dental Extraction |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HCR/III/POLPARAPI/03/2023 Version 2.0 Date 14-06-2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shubhadeep Sinha MD |
| Designation |
Senior Vice President and Head |
| Affiliation |
Hetero Group |
| Address |
Clinical Development and Medical Affairs, Hetero Corporate, 7-2-A2,
Industrial Estates, Sanath Nagar
Hyderabad
TELANGANA
500018
India |
| Phone |
|
| Fax |
|
| Email |
sd.sinha@hetero.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreenivasa Chary S |
| Designation |
Senior General Manager |
| Affiliation |
Hetero Labs Limited |
| Address |
Clinical Development and Medical Affairs, Hetero Corporate, 7-2-A2,
Industrial Estates, Sanath Nagar
Hyderabad
TELANGANA
Hyderabad
TELANGANA
500018
India |
| Phone |
914023704923 |
| Fax |
914023801902 |
| Email |
Sreenivasa.Chary@hetero.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subhadeep Sinha MD |
| Designation |
Senior Vice President |
| Affiliation |
Hetero Labs Limited |
| Address |
Clinical Development and Medical Affairs, Hetero Corporate, 7-2-A2,
Industrial Estates, Sanath Nagar
Hyderabad
TELANGANA
Hyderabad
TELANGANA
500018
India |
| Phone |
914023704923 |
| Fax |
914023801902 |
| Email |
sd.sinha@hetero.com |
|
|
Source of Monetary or Material Support
|
| Hetero Labs Limited, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad,
Telangana, India-500018 |
|
|
Primary Sponsor
|
| Name |
Hetero Labs Limited |
| Address |
Hetero Labs Limited, Hetero Corporate, 7-2-A2, Industrial Estates,
Sanath Nagar, Hyderabad, Telangana, India-500018 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr D Srihari |
ACSR Government Medical College& Hospital |
Department of Dentistry, 2nd Floor,Room No18 ,Dargamitta, Nellore 524004,India
Nellore
ANDHRA PRADESH |
7780630757
doddagasrihari@gmail.com |
| Dr Vishwesh Prashant Joshi |
Hi-Tech Multispeciality Hospital |
Department of Dentistry, Room No 02 , Ground Floor, Sector3-D, Plot No.1180, Gh Road, Nr. Gh-11/2 Bus stand, 382003, India
Gandhinagar
GUJARAT |
9426455174
vishweshjoshi1905@gmail.com |
| Dr Balram Choudhary |
Jawahar Lal Nehru Medical College |
Department of Dentistry, Ground Floor , Room No 101, Kala Bagh, Ajmer-305001,India
Ajmer
RAJASTHAN |
8118877284
clinical.jln@gmail.com |
| Dr Soma Halder |
Medical College and Hospital |
Department of Dentistry, Second Floor ,Room No, 409, 88 College Street, Kolkata 700073,India
Kolkata
WEST BENGAL |
9475679714
somahalderortho2@gmail.com |
| Dr Archana H Lanje |
MLB Medical College |
Department of Dentistry, 1st Floor, Room No 77,Kanpur Road ,Jhansi 284128,India
Jhansi
UTTAR PRADESH |
8009446767
drarchanamisurya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee, MLB Medical College& Associated Hospital |
Submittted/Under Review |
| Hi-Tech Ethics Committee |
Approved |
| Institutional Ethics Committee ACSR Government Medical College& Hospital |
Submittted/Under Review |
| Institutional Ethics Committee for Human Research, Medical College and Hospital |
Submittted/Under Review |
| Institutional Ethics Committee Jawahar Lal Nehru Medical College |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G978||Other intraoperative and postprocedural complications and disorders of nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Etoricoxib 60mg and Paracetamol
325mg Tablets |
One tablet once a day with food for 3
days |
| Intervention |
Polmacoxib 2mg and Paracetamol 325mg
tablets |
One tablet once a day with food for 3
days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult male or female subjects aged of 18-65 years.
2. Subjects willing to give written, signed, and dated informed consent to participate
in the study.
3. Subjects requiring dental extraction other than 3rd molar.
4. Patients who agree not to use any other approved or experimental
pharmacological treatments for their pain, other than mentioned in the protocol,
at any time during the study.
5. Females of childbearing potential who are sexually active must agree to use
barrier contraception and can neither be pregnant nor lactating from screening
throughout the duration of the study.
6. Clinical laboratory evaluations (including clinical chemistry, hematology, and
complete urinalysis) within the reference range for the testing laboratory or the
results are deemed not clinically significant for inclusion into this study by the
investigator. |
|
| ExclusionCriteria |
| Details |
1. Patients with any contraindication, hypersensitivity or intolerance to either
paracetamol or polmacoxib or with history of hypersensitivity reactions to drugs
of similar chemical classes or to any of its excipients
2. History of Hepatitis B, Hepatitis C or HIV infection.
3. Patients on anticonvulsants, antidepressants (e.g., tricyclic, tetracyclic, atypical),
aspirin at doses >81 mg/day, benzodiazepines, opioids, herbal medications,
mexiletine HCl.
4. Patients using the following medications:
a. Use of anticoagulants within 2 weeks of screening
b. Use of analgesics within 48 hours before screening (except
acetaminophen 650 mg/ day as rescue medication)
c. Use of steroids within 6 weeks or currently on steroids.
5. Concurrent use of corticosteroids, herbal medicines, traditional medicines,
nutraceuticals, glucosamine, and/or chondroitin sulfate.
6. Patients with HbAlc greater than 8% at screening
7. Patients with history of epilepsy or seizure disorder requiring treatment with antiepileptic
drugs.
8. Patients with known alcohol or other substance abuse within last one year.
9. Patients with history of cardiovascular disease (uncontrolled hypertension i.e.
≥140/90 mm of Hg, congestive heart failure, ischemic.
10. If serum NT-pro-BNP level is greater than 125 pg/mL.
11. Subjects with history of rheumatic fever.
12. Subjects with history of blood dyscrasia (i.e. hemophilia or platelet disorders.
13. Subjects with acute pericoronal abscess or pericoronitis or Ludwig’s angina.
14. Subjects with history of heavy irradiation for dental lesions.
15. Dental extraction site is in proximity to an area of infection or malignancy.
16. Subjects with history of malignant disorders like leukemia and lymphoma.
17. Medical condition or disorder that would interfere with the ADME of study drugs. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percent change in mean pain intensity decrease measured by Numeric Pain Rating
Scale from start of medication to 48 hours |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percent change in mean pain intensity decrease measured by Numeric Pain Rating
Scale |
Baseline, 6, 24, 48 hours |
| Change in mean pain intensity decrease measured by Numeric Pain Rating Scale |
Baseline to 6 hours, 24 hours and 48 hours |
Mean Sum of Pain Intensity Difference (SPID)
(NPRS SPID-6, NPRS SPID-24, NPRS SPID-48) |
0 to 6, 0 to 24 and 0 to 48 hours |
| Change in mean pain relief score on a 5-point scale |
6 hours, 24 hours and 48 hours |
Total pain relief (TOTPAR-6,
TOTPAR-24, TOTPAR-48) |
0 to 6, 0 to 24 and 0 to 48 hours |
| Proportion of subjects used rescue medication during the study period |
48 hours |
| Patient’s Global Impression of Improvement (PGI-I) |
6 hours, 24 hours and 48 hours |
| Treatment emergent clinical & laboratory adverse events (TEAEs). |
48 hours |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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 3 |
|
Date of First Enrollment (India)
|
30/11/2023 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 prospective, multicentric, double blind, randomized, active controlled, parallel study designed to evaluate the efficacy and safety of FDC of polmacoxib 2mg and paracetamol 325mg (test- drug) compared to FDC of etoricoxib 60mg and paracetamol 325mg (reference drug) in adults with acute pain due to dental extraction. Adult male and female subjects (18 – 65 years), across the country among 10-12 geographically distributed study sites, with acute pain due to dental extraction would be recruited, who meet all the inclusion criteria and none of the exclusion criteria, to assess the pain intensity with Numeric Pain Rating Scale (NPRS). Since the study is designed to carry in 1:1 ratio of test versus reference treatments, 144 patients (72 per arm) would be sufficient to prove non-inferiority of test drug compared to reference drug at one sided 2.5% level of significance, 80% power and -20% of noninferiority margin. The demographic and baseline characteristics will be assessed before initiating the study. Percent change in mean pain intensity decrease measured by NPR scale from start of medication to 48 hours, percent change in mean pain intensity decrease measured by NPR scale from start of medication to 6 hours and 24 hours are the primary and secondary study endpoints respectively. Change in mean pain intensity decrease, mean sum of pain intensity difference over 0 to 6, 0 to 24 and 0 to 48 hours (NPRS SPID-6, NPRS SPID-24, NPRS SPID-48), change in mean pain relief score on a 5-point scale at 6 hours, 24 hours and 48 hours, total pain relief (TOTPAR) over 0 to 6, 0 to 24 and 0 to 48 hours (TOTPAR-6, TOTPAR-24, TOTPAR-48), proportion of subjects used rescue medication during the study period, patient’s global impression of improvement (PGI-I) at 6 hours, 24 hours and 48 hours are the different treatment outcome measures at respective time points. Treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse drug reactions (ADRs), clinical & laboratory parameters, vital signs, and electrocardiogram (ECG) data in 8 weeks.
|