| CTRI Number |
CTRI/2009/091/000056 [Registered on: 29/01/2010] |
| Last Modified On: |
18/12/2012 |
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Crossover Trial |
Public Title of Study
Modification(s)
|
A clinical trial to compare the combination of Lornoxicam and Paracetamol with Lornoxicam alone in relieving pain and other symptoms. |
|
Scientific Title of Study
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A comparative clinical trial for the evaluation of the efficacy and safety of FDC of Lornoxicam (4 mg) and Paracetamol (500 mg)with Lornoxicam (4 mg) alone for short term treatment of mild to moderate pain associated with extra articular inflammation |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Dipak Vyas |
| Designation |
|
| Affiliation |
|
| Address |
Vyas Clinic, 106, Sundaram
Sion Circle
Mumbai
MAHARASHTRA
400022
India |
| Phone |
022-24076487 |
| Fax |
|
| Email |
drdipakvyas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Manish Maladkar |
| Designation |
|
| Affiliation |
|
| Address |
Aristo Pharmaceuticals Pvt Ltd
23- A shah industrial estate, off veera desai rd andheri W
Mumbai
MAHARASHTRA
400053
India |
| Phone |
02226739999 |
| Fax |
02226734792 |
| Email |
scientific@aristopharma.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Manish Maladkar |
| Designation |
|
| Affiliation |
|
| Address |
Aristo Pharmaceuticals Pvt Ltd
23- A shah industrial estate, off veera desai rd andheri W
Mumbai
MAHARASHTRA
400053
India |
| Phone |
02226739999 |
| Fax |
02226734792 |
| Email |
scientific@aristopharma.org |
|
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Source of Monetary or Material Support
|
| Aristo pharmaceuticals pvt ltd |
|
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Primary Sponsor
|
| Name |
Aristo Pharmaceuticals pvt ltd Mumbai |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Manish Shah |
Rhushabh Nursing Home |
C-2/201, Anjana Apartments,S.V. Road, Shimpoli Road Junction, BorivaliI (W),-400092
Mumbai
MAHARASHTRA |
0222899 22 61
manishhs1960@rediffmail.com |
| Dharamshri Kadam |
Sanjeevani Medical Centre |
11, New Shopping Complex, ,Sector 7, C.G.S. Colony,-400037
Mumbai
MAHARASHTRA |
dharmashrikadam@hotmail.com |
| Dr. Dipak Vyas |
Vyas Clinic |
Alka Mansion, 254,Dr. Ambedkar Rd, Sion (West)-400 022
Mumbai
MAHARASHTRA |
02224090366
drdipakvyas@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethical committee of Lions Tarachand Bapa Hospital, Sion. |
Approved |
| Independent ethics committee. 4 Sharavati, Worli |
Approved |
| Independent ethics committee. 4 Sharavati, Worli |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
pain associated with extra articular inflammation, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lornoxicam |
4 mg |
| Intervention |
Lornoxicam, Paracetamol |
FDC |
|
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Inclusion Criteria
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| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Patients with either sex, from 18-60 years age. Informed consent, extra articular inflammation. |
|
| ExclusionCriteria |
| Details |
Female pregnant or with chances of pregnancy or nursing, History of allergy or hypersensitivity. physical/clinical abnormalities, any condition which affect study of drug. |
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Method of Generating Random Sequence
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Method of Concealment
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy and safety of combination |
5 days |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Tolerability and safety of the product |
|
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Target Sample Size
|
Total Sample Size="201"
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" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/02/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
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Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This study was comparative evaluation of a fixed dose combination of Lornoxicam & Paracetamol in short term management of mild to moderate pain in patients with extra-articular inflammation. The results shows that the combination gives better relief from pain, mobility restrictions and tenderness compared to Lornoxicam alone. |