| CTRI Number |
CTRI/2010/091/001041 [Registered on: 07/09/2010] |
| 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 effects of Tapentadol in patients with osteoarthritis & post-operative pain after orthopedic surgery. |
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Scientific Title of Study
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A MULTICENTRIC, OPEN-LABEL, ANALYST-BLIND, RANDOMIZED, PARALLEL-GROUP, TRAMADOL-CONTROLLED, PHASE-III CLINICAL TRIAL TO ASSESS THE EFFICACY, TOLERABILITY, AND SAFETY OF TAPENTADOL TABLETS IN PATIENTS OF OSTEOARTHRITIS & POST-OPERATIVE PAIN AFTER ORTHOPEDIC SURGERY? |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| DSCS/MSN/TAPENTADOL/CT/0709A |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Dr.Vinayak Samant |
| Designation |
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| Affiliation |
|
| Address |
Dr.Samant Hospital, Navi Mumbai-400705
Mumbai
MAHARASHTRA
400705
India |
| Phone |
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| Fax |
|
| Email |
drvinayaksamant@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr.Vinayak Samant |
| Designation |
|
| Affiliation |
|
| Address |
Dr.Samant Hospital, Navi Mumbai-400705
Mumbai
MAHARASHTRA
400705
India |
| Phone |
|
| Fax |
|
| Email |
drvinayaksamant@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Dr.Vinayak Samant |
| Designation |
|
| Affiliation |
|
| Address |
Dr.Samant Hospital, Navi Mumbai-400705
Mumbai
MAHARASHTRA
400705
India |
| Phone |
|
| Fax |
|
| Email |
drvinayaksamant@gmail.com |
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Source of Monetary or Material Support
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| M/s. MSN Laboratories Ltd. |
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Primary Sponsor
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| Name |
M/s. MSN Laboratories Ltd., Hyderabad |
| 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 = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Nitin Rathod |
Dr. R. N. Cooper Hospital , Mumbai, nitinmr@yahoo.in |
Dr. R. N. Cooper Hospital , Mumbai, nitinmr@yahoo.in,-
Mumbai
MAHARASHTRA |
|
| Dr. Vinayak Samant |
Dr.Samant Hospital, Navi Mumbai-400705, drvinayaksamant@gmail.com |
Dr.Samant Hospital, Navi Mumbai-400705, drvinayaksamant@gmail.com,-
Mumbai
MAHARASHTRA |
drvinayaksamant@gmail.com |
| Dr. Amrut M Patel |
Hetal Orthopedic Hospital, Sabarkantha, amrut_Hmt@rediffmail.com |
,-
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amrut_Hmt@rediffmail.com |
| Dr. Shashikant Nawale |
Shalyak Hospital, Jogeswari (W), Mumbai, snawale@hotmail.com |
Shalyak Hospital, Jogeswari (W), Mumbai, snawale@hotmail.com,-
Mumbai
MAHARASHTRA |
snawale@hotmail.com |
|
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Details of Ethics Committee
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| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
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 |
Osteoarthritis & Post-Operative Pain after Orthopedic Surgery, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Tapentadol |
50mg |
| Comparator Agent |
Tramadol |
50mg |
|
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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 |
■ All patients with duly filled and signed in ICFs [Informed Consent Forms]
■ Ages: > 18 years and < 80 years
■ Genders Eligible for Study: both
■ Patients who are candidates for orthopedic surgery.
■ Patients requiring daily doses of analgesics, consistent with treatment at step II or higher of the World Health Organization pain relief ladder.
■ In addition, eligible patients has to report a mean pain intensity score > 5 on an II-point numerical rating scale (NRS) over 3 days of pain measurements completed before randomized assignment to treatment groups.
■ Women of childbearing age using accepted mode of birth control.
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| ExclusionCriteria |
| Details |
■ The exclusion criteria are based on precautions related to centrally acting analgesics and the standard conduct of clinical trials.
■ Patients unwilling to sign on ICF
■ Patients with a history of chronic hepatitis B or C infection, HIV infection,
■ Patients with presence or history of malignancy (within the last 2 years), or alcohol or drug abuse.
■ Patients with suspected or apparent seizure disorders, concomitant autoimmune inflammatory conditions involving the target joint, acute crystal-induced arthropathy (within 6 months before screening), moderate to severe renal insufficiency, or hepatic impairment.
■ Patients will also be excluded if they have received systemic steroid therapy within 4 weeks before screening, IR opioids for >4 days per week within 28 days of the screening period, or extended-release opioids within 28 days of the screening period.
■ Patients who have received an experimental drug or used an experimental device within 28 days of study entry will be excluded from participation, as will be patients with a history of sensitivity to Tapentadol, hydromorphone, morphine, fentanyl, or their excipients.
■ Patients who had previously participated in studies of Tapentadol will also be excluded.
■ Pregnant or lactating patients
■ Patients having abnormal liver parameters such high values of AST, ALT and ALP,
■ Patients having received other investigational medication within the last 3 months, or having participated in the trial.
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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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On-site computer system |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| The primary efficacy outcome for this study is the evaluation of pain done on twice daily basis by the patient himself using 11-point NRS scale, where 0 is no pain and 10 is worst possible pain experienced.
The investigator will perform this test on day 0 i.e. day of randomization, day 5 i.e. day of interim analysis and day 10, which is the end of the study period.
2] Pain intensity difference (PID)
This will be used to examine the change in pain intensity from baseline and will be calculated as baseline pain intensity - current pain intensity, with the mean pain intensity from the 3 days of pain intensity measurements before randomization used as the baseline value. Sum of PID over the first 5 days (5-day SPID), the primary efficacy end point, will be calculated as ΣPID (time elapsed since the previous observation), with the sum including all observations of PID collected from the evening of day 1 to the evening of day 5. Two-day SPID and 10-day SPID will be calculated in a similar manner.
|
10 day |
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Secondary Outcome
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| Outcome |
TimePoints |
| Secondary outcomes include the effect of Tapentadol IR on the basis of Patient Global Impression of Change (PGIC) at the baseline, day 5 and day 10, which is the end point of the trial. PGIC will be assessed, wherein patients will indicate their response to the statement "Since I began study medication, my overall status is ..." using a scale from 1 =very much improved to 7 =very much worse. |
10 day |
| Secondary outcomes include the effect of Tapentadol IR on the basis of Patient Global Impression of Change (PGIC) at the baseline, day 5 and day 10, which is the end point of the trial. PGIC will be assessed, wherein patients will indicate their response to the statement "Since I began study medication, my overall status is ..." using a scale from 1 =very much improved to 7 =very much worse. |
10 day |
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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) |
01/08/2010 |
| 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="5"
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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This study is a randomized, open label, parallel group, multi centre trail comparing the safety and efficacy of Tapentadol in patients with Osteoarthritis & Post-Operative Pain after Orthopedic Surgery for 5 months in 200 patients will be conducted in four centres in India |