Research Projects / Clinical trials :Sr.n
o.
Title of Project
1
2
Pain Management (Rofecoxib)
Osteoarthritis/Degenerative
(Rofecoxib V/s Diclofenac)
Pain Management (Naproxen)
Pain Management (Nimesulide)
Muscoskeletal Spasm associated
with low BACK pain (Zaltokin).
Osteoarthritis / Degenerative
Disease (Etoricoxib)
Evaluation of Efficacy & Tolerability
of a fixed Dose Combination of
Eperisone Hydrochloride &
Diclofenac Sodium In The
Treatment of Acute
Musculoskeletal Spasm Associated
with Low Back Pain :An observer
Blind , Prospective,Randomized ,
Controlled Study.
OSKIRA 2- D4300C00002: Phase 3,
Multicentre, Randomized, Double
Blind, Placebo-Controlled, Parallel
Group Study of Two Dosing
Regimens of Fostamatinib
Disodium in Rheumatoid Arthritis
Patients with an Inadequate
Response to DMARDs.
3
4
5
6
7
8
Sponsor / CRO
Phase
of trial
Duration From
Duration To
IV
IV
2002
2002
No.
of
pati
ents
enr
olle
d
10
20
IV
IV
III b
2005
2007
2011
20
100
30
IV
2011
10
Amount Received
EISAI
Pharmaceuticals
India Pvt. Ltd./
CRO- Clinsearch.
(National )
III b
01/02/2011
03/05/2011
60
Rs 2000 per patient
(for 10 days)
AstraZeneca
AB,Sweden./
CRO-Quintiles.
(Global)
Phase
III
06/04/2011
Till Date
7
Rs 2.37 Lakhs Per Patient
(for 1 year)
Phase
III
06/04/2011
Till Date
5
Rs 1,58,864 Lakhs
Per Patient (for 1 year)
9
OSKIRA-X-D4300C00005: A longterm Extension Study to assess the
safety and Efficacy of Fostamatinib
Disodium (FosD) in the Treatment
of Rheumatoid Arthritis.
AstraZeneca
AB,Sweden./
CRO-Quintiles.
(Global)
10
A Multicentre ,Double-Blind,
Vehicle Controlled ,Parallel-Group
Study Comparing a Generic
Diclofenac Sodium Topical Gel ,1%
to Voltaren Gel (Diclofenac Sodium
Topical Gel) 1% in the Treatment of
Subjects with Osteoarthritis of the
knee.
Amneal
pharmaceuticals,
New York./ CROQuintiles.
Site Selected
Rs 25,428 per patient
(For 4 months)
11
12
13
14
15
16
A control-Labeled ,prospective
,Randomized ,Parallel Group,
Multicentric ,Phase III Clinical trial
to Evaluate Efficacy & Safety of a
FDC of Lornoxicam 16 mg SR +
Thiocolchicoside 16 mg SR Tablet
OD Compared with
Thiocolchicoside 8 mg Capsule BID
in Patients suffering from pain
associated with Skeletal Muscular
Spasm of any etiology.
A Randomized , Active –Control
,Prospective ,Parallel ,Multicenter,
Comparative phase –III ,Clinical
Study of Evaluate Efficacy ,Safety &
Tolerability of Tapentadol 200 mg
Sustained Release Tablet BID with
Tapentadol 100 mg Tablet QID in
Subjects Suffering with Chronic
Pain of any etiology.
CORRONA Registry Study
Tinefcon /61 /11: Randomized
double blind ,Parallel
group,Placebo Controlled
,Prospective ,Phase II Study to
evaluate The Safety And Efficacy of
TNF – Alpha Inhibitor Tinefcon In
Subjects with Active Ankylosing
Spondylitis.
A phase III, Prospective
,Randomized , Interventional ,
Multicentre Double blind Study
designed to asses the safety and
tolerability of PTH in
Postmenopausal Women suffering
with osteoporosis.
A Randomized ,Double- blind
,Placebo controlled , Parallel
,Multicetre,Phase-II Study, To
evaluate The Efficacy and Safety of
ITOLIZUMAB administered
intravenously in combination with
background oral Methotrexate
(MTX) or MTX and
hydroxychloroquine ( HCQ) in
patients with active Rheumatoid
Arthritis ( RA) having an inadequate
response to MTX/MTX+HCQ
Inventia
Healthcare pvt.
Ltd. India./ CRO
Nexus Clinical
Research Pvt.Ltd.
Phase
III
31-05-12
Inventia
Healthcare pvt.
Ltd. India./ CRO
Nexus Clinical
Research Pvt.Ltd.
Phase
III
Feasibility
Filled
CORRONA
International
,LLC,USA/CRO –
Icon Clinical
Research .
Piramal Life
Sciences Ltd./
CRO-Invocon
Research Pvt. Ltd.
Feasibility
Filled
Phase
II
Feasibility
Filled
CRO-Makrocare
Clinical Research
ltd.
Phase
III
Feasibility
Filled
Clinigene
International
Ltd./CRO- Axiom
Lifesciences
Pvt.Ltd.
Phase
II
Feasibility
Filled
01-08-12
64
1,500 per patient.
(for 1 month)
1,500 per patient.
(for 1 month)
17
OA Knee.
CRO- Standev
Research Pvt.Ltd.
Feasibility
Filled
18
An investigator-blinded ,placebocontrolled ,randomized ,parallel
group comparison of the effects of
a single dose of Maxigesic
(Paracetamol 325 mg + Ibuprofen
97.5 mg -3 tablets ) versus Nurofen
(ibuprofen 400 mg) in participants
with moderate to severe pain from
removal of at least two third
molars.
Synchron
Research Services
Pvt. Ltd.
Feasibility
Filled
19
20
21
22
“A Randomized, Active-Control,
Prospective, 2 Arm Parallel Group,
Multicenter, Phase- III Clinical
Study to Evaluate the Efficacy,
Safety
and
Tolerability
of
Minodronic acid 50mg Tablet,
Once Per 4 Weeks in comparison
with Alendronic Acid 70mg Tablet,
Once Weekly in Postmenopausal
Women
Diagnosed
with
Osteoporosis”
Feasibility
Filled
MSN Laboratories
India Pvt.Ltd.
Phase
III
A Multicenter, Randomized
,Double-blind , Placebo-controlled,
Parallel Group Study of CNTO 136
(sirukumab ),a Human Anti-IL-6
Monoclonal Antibody
,Administered Subcutaneously , in
Subjects with Active Rheumatoid
Arthritis Despite DMARD Therapy .
PAREXEL
INTERNATIONAL
Clinical Research
Pvt. Ltd.(CROJanssen research
& Development ,
LLC )
Feasibility
Filled
2
1
A Randomized,
Double-Blind
Placebo-Controlled 52-Week
Study to Assess Adverse
Events of Special Interest in
Adults with Active,
Autoantibody-Positive
Systemic Lupus Erythematosus
Receiving Belimumab
CRO - Quintiles
Feasibility
Filled
A Randomized ,Double-blind ,
Placebo & active controlled,
Parallel Group Study to evaluate
the analgesic efficacy & safety of a
fixed combination of
PAREXEL
INTERNATIONAL
Clinical Research
Pvt. Ltd.
Feasibility
Filled
3,500 per Patient
dexketoprofen trametamol &
tramadol hydrochloride on
moderate to severe acute pain
after unilateral elective total hip
arthroplasty.
23
24
CRECEL Study- Evaluation of
clinical & linezolid combination
FDC
A Randomised, Double-blind,
Parallel Group, Multicentre Clinical
Study to Evaluate the Efficacy,
Safety, Pharmacokinetics and
Immunogenicity of SB4 Compared
to Enbrel® in Patients with
Moderate to Severe Rheumatoid
Arthritis
SAMSUNG
BIOEPIS
A Multicentre,
randomized, open
2
lable, two
5 period, two treatment,
two way ,crossober, single dose,
bioequivalence study compairing ,
Azathioprine tablets USP 50 mg
strides arco lab limited (India) with
Imuran 50 mg Azathiprine tablets
USP 50 mg PROMETHUS
LABORATORIES INC. in adults
patients with Rheumatoid Arthritis
under fasting conditions
Strides Arcolab
Limited.
Bangalore
(INDIA).
IV
August 2012
Site Selected
August
2012
2