| CTRI Number |
CTRI/2010/091/001028 [Registered on: 19/07/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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A clinical trial to study the effect of Tapentadol HCl compared to Tramadol in post operative dental patients. |
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Scientific Title of Study
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An Open, Comparative, Randomized, Prospective, Multi Centric Clinical Trial To Compare The Efficacy And Safety Of Tapentadol HCl-IR Versus Tramadol HCl In Case of Post-operative Dental Patients |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| CT-32-TAPE-2009 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Dr.Ashish Mungantiwar |
| Designation |
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| Affiliation |
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| Address |
G-2, Shanti nagar
Mahakali caves rd, Andheri-East
Mumbai
MAHARASHTRA
400059
India |
| Phone |
02228314611 |
| Fax |
02228304641 |
| Email |
drashish@macleodspharma.com |
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Details of Contact Person
Scientific Query
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| Name |
Mr.Amol Choulwar |
| Designation |
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| Affiliation |
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| Address |
G-2,Shanti Nagar, Mahakali caves rd,
Andheri-East
Mumbai
MAHARASHTRA
400059
India |
| Phone |
02228306435 |
| Fax |
02228304641 |
| Email |
achoulwar@macleodspharma.com |
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Details of Contact Person
Public Query
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| Name |
Mr.Amol Choulwar |
| Designation |
|
| Affiliation |
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| Address |
G-2,Shanti Nagar, Mahakali caves rd,
Andheri-East
Mumbai
MAHARASHTRA
400059
India |
| Phone |
02228306435 |
| Fax |
02228304641 |
| Email |
achoulwar@macleodspharma.com |
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Source of Monetary or Material Support
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| Macleods Pharmaceuticals Ltd |
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Primary Sponsor
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| Name |
Macleods Pharmaceuticals Ltd
G-2, Mahakali Caves Road, Shanti Nagar,
Andheri-East, Mumbai-400059 |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.Shailesh Kumar |
city dental clinic |
23, Lalsai apartment,,Palsikar colony-452001
Indore
MADHYA PRADESH |
07312622626
citydentalclinic777@gmail.com |
| Dr.D.Dinesh |
Dental Specialista Clinic |
#2, Services Road,,Remco layout, Vijaynagar,-560040
Bangalore
KARNATAKA |
0803403052
drdineshd@yahoo.com |
| Dr.R.V.Shivhare |
Dr.Rajesh Shivhare |
Shop No.3 and 4,Atharva apartment,,Shanti Nagar-401101
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02228144968
rajeshvshivhare@yahoo.com |
| Dr.H.L.Gupta |
Rama Kripa |
F-27, Kisan Marg,Tonk road-302018
Jaipur
RAJASTHAN |
hlgupta7@yahoo.co.in |
| Dr.L.R.Sharma |
Sharma Dental Clinic |
327-A, Pocket-A1,Sector-6, rohini-110085
New Delhi
DELHI |
01127042389
drlokrajsharma@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee for Dr.D.Dinesh |
Approved |
| Independent Ethics Committee for Dr.H.L.Gupta |
Approved |
| Independent Ethics Committee for Dr.L.R.Sharma |
Approved |
| Independent Ethics Committee for Dr.Rajesh Shivhare |
Approved |
| Independent Ethics Committee for Dr.Shailesh kumar |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Post-operative Dental Patients, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Tapentadol HCl-IR Tablet 100mg |
Dose: One tablet every 4-6 hrs in a day
Duration-3 days |
| Comparator Agent |
Tramadol HCl Tablet 100mg |
Dose: One tablet every 4-6 hrs in a day.
Duration-3 days |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1. Patient of either sex with an age of 18 - 75 years
2. Patients ready to give informed consent to participate in the trial
3. Surgical procedure involving removal of >= 2 impacted third molars with bone removal required for at least 2 of the 3 impacted third molars
4. At least moderate pain within 5 hours after oral surgery procedure
5. Sufficiently alert to follow directions, communicate with study personnel and perform study procedures
6. If female, using an acceptable method of birth control and has a negative urine pregnancy test
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| ExclusionCriteria |
| Details |
1. Patients will be excluded from the study if they have a history of seizure disorder or epilepsy
2. Previously treated patients who have discontinued treatment due to an adverse event
3. History of malignancy within the past 2 years before starting the study
4. History of alcohol or drug abuse
5. Evidence of active infections that may spread to other areas of the body
6. Clinical laboratory values reflecting severe renal insufficiency
7. Moderately or severely impaired hepatic function
8. Patients with an uncontrolled medical condition
9. Patients who have used pain medication (other than anesthesia) within 24 hours of receiving study medication, any long-acting over-the-counter pain medications within 3 days, or any pain medication after finishing oral surgery
10. Currently treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake inhibitor (SNRI)
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Global Clinical assessment for functional signs of post-operative dental pain:
-Peak Pain relief (PPR)
-Peak Pain intensity difference (PPID)
-Total Pain relief over 8 hrs (TOTPAR-8)
-Total Pain relief over 4 hrs (TOTPAR-4)
-Sum of Pain intensity difference at 8 hrs (SPID-8)
-Sum of Pain intensity difference at 4 hrs (SPID-4)
-Percentage of patients experiencing 50% pain relief
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Visit 1: Day 01 Admission to the study
Visit 2: Day 02 During therapy visit
Visit 3: Day 03 End of therapy visit
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Secondary Outcome
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| Outcome |
TimePoints |
| Efficacy will be graded as follows:
a] Cured: Significant Improvement in the severity of symptoms and parameters of evaluation of Post-operative dental pain.
b] Failure: Either no improvement or worsening of severity of symptoms and parameters of evaluation of Post-operative dental pain at the end of therapy.
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At end of treatment |
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Target Sample Size
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Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/07/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="0"
Months="4"
Days="0" |
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Recruitment Status of Trial (Global)
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Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Tapentadol is an opioid analgesic indicated for the relief of moderate to severe acute pain in patients 18 years of age or older.
Tapentadol is a centrally-acting synthetic analgesic that activates opioid receptors in the brain, spinal cord and gastrointestinal tract, and also inhibits reuptake of norepinephrine.
It is a open, Comparative, Randomized and Prospective, Phase-III, Multicentric Clinical Trial caomparing the efficacy and safety of Tapentadol 100mg and Tramadol 100mg for 3 days in 200 patients of post operative dental pain.
Study Duration:3 Days
Primary diagnosis:Patients suffering from moderate to severe dental pain associated with Post-operative surgery, Molar surgery.
For this study a total of 200 patients will be enrolled from different centers. These 200 patients will be randomized for Group-A (i.e. Tapentadol HCl-IR) or Group-B (i.e. Tramadol HCl), 100 patients in each group.
All these patients will be recruited from different centres.
Efficacy will be evaluated based on the acute dental pain as highly standardized and sensitive for therapeutic efficacy of treatment medicine and the efficacy measures used are considered valid, reliable, sensitive and specific method to assess post-operative dental pain.
Depending on inclusion and exclusion criteria patient will be enrolled for the study.
After recording the history of patients disease condition and treatment received patient will undergo laboratory investigations for assessment of baseline safety and efficacy parameters. Patient will also undergo a physical examination.
Patient will either receive Tapentadol HCl-IR tablet 100mg one tablet every 4-6 hrs in a day or Tramadol HCl tablet 100mg one tablet every 4-6 hrs in a day depending on group assigned, for a period of 3 days.
patient will be required to come for follow up on Day-1, Day-2 & at the end of therapy i.e. on Day-3. patient will be subjected to physical and clinical examination during all these follow up visits. While patient will undergo for second round of laboratory investigation at the end of treatment.
Adverse events experienced by patients, if any, will be recorded during these visits.
Efficacy will be graded as follows:
a] Cured: Significant Improvement in the severity of symptoms and parameters of evaluation of Post-operative dental pain.
b] Failure: Either no improvement or worsening of severity of symptoms and parameters of evaluation of Post-operative dental pain at the end of therapy.
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