Study
Coordinator
Gretchen Daulton
manager29@aol.com
ONGOING STUDIES
1.
A
Randomized Double-Blind, Parallel Study of Rabeprazole Extended
Release 50 mg Versus Esomeprazole 40 mg for healing of and
symptomatic relief of Moderate to severe Erosive
gastroesophageal Reflux Disease (GERD).
Eisai Pharmaceuticals
2008
2.A Randomized Double-Blind, Parallel Study of Rabeprazole
Extended Release 50 mg Versus Esomeprazole 40 mg for healing of
and symptomatic relief of Mild to Moderate Erosive
gastroesophageal Reflux Disease (GERD).
Eisai Pharmaceuticals
2008
3.
A Randomized double-blind, placebo controlled evaluation of the
safety, efficacy, and pharmacokinetics of multiple
doses of Basiliximab, with concomitant corticosteroids, in steroid
refractory Ulcerative Colitis.
Cerimon
Pharmaceuticals
2007
(Recruiting new participants)
4. A Multi-center, Randomized, Double blind, Placebo controlled
Trial to Evaluate the
Efficacy, Safety, and Tolerability of Rifaximin 550 MG BID
for 6 months in preventing Hepatic Encephalopathy.
Salix
Pharmaceutical, Inc.-
RFHE3001
2007
(Recruiting new participants)
5. A Multi-center, open-label Trial to evaluate the long term
safety and tolerability of Rifaxamin 550 mg BID in subjects
with history of Hepatic Encephalopathy.
Salix Pharmaceutical,Inc. RFHE3002
2007
(Recruiting new participants)
6. Clin-AG1003-007 An open label, safety study of AGI-003
((Arverapamil) in treatment of
Irritable Bowel
Syndrome
with Diarrhea (IBD-D).
AGI-Therapeutic Research Ltd.
(Recruiting new
participants)
7.
A
Multi-Center, investigator-blinded, randomized, 12-months,
Parallel-group, Non-inferiority Study to Compare the Efficacy
of
1.6 to 2.4 g Asacol Therapy QD Versus Divided doses (BID) in
maintenance of Remission of Ulcerative Colitis.
(Recruiting new participants).
CLINICAL TRIALS CONDUCTED AT OUR SITE
1. 24
weeks double blind, Ibuprofen (800 MG PO TID) controlled
to evaluate a combination of NSAID and
Fomatidine in reducing the risk of NSAID associated
endoscopically diagnosed, gastric or duodenal ulcers
in patients who require the use of long term NSAIDs. 4
endoscopies will be required for each patient. 6 month
extension study may be possible.
(Recruitment closed)
2.
A Randomized, Double-blind, Placebo controlled, Multicenter,
Parallel group Study to assess the Efficacy
(reduction in Cardiovascular Disease Events) and safety of 100 mg
Enteric-coated Acetylsalicylic Acid in patients
at Moderate risk of Cardiovascular Disease.
(Recruitment closed)
3. AMulti-center,
Randomized, Double blind, Placebo controlled Trial to Evaluate
the Efficacy, Safety, and
Tolerability of Rifaximin 550 MG BID for 6 months in
preventing Hepatic Encephalopathy.
Salix Pharmaceutical, Inc.-
RFHE3001 2007
4. A Multicenter, randomized, double blind,
activity controlled trial to evaluate the safety and efficacy
Placebo
controlled, parallel group study of Renzapride in women with
constipation-predominant Irritable Bowel
Syndrome (IBS).
Quintiles, Inc.- Alizyme
Therapeutic
2007
5. A Multicenter, open label study, treatment
Extension Trial to Evaluate the long-term safety and
tolerability
of Mesalamine pellet formulation maintain remission in mild to
Moderately active Ulcerative Colitis 3005.
Parexel Salix Pharmaceutical, Inc.
2006
6.
A phase 2 double blind study to evaluate the safety and efficacy
of Illaprazole ( 5 MG, 20 MG and 40 MG QD)
on healing of Erosive
Esophagitis).
TAP Pharmaceutical Products Inc.
2007
7. A Multicentre, randomised, open-label, active controlled,
parallel arm study to compare the efficacy of 12
weeks of treatment with Vildagliptin 100 mg, qd to
Thiazolidinedione (TZD) as add-on therapy in patients
with type 2 diabetes inadequately controlled with
Metformin monotherapy in a community-based practice
setting.
Novartis Pharmaceutical, Inc.
2006-2007
8. Randomized, Double blind, Placebo controlled Trial to
Evaluate the Efficacy, Safety, and Tolerability of new
tablet formulation and dosing regimen of Balsalazide Disodium
3.3 G BID versus Mesalamine (5-ASA) as Asacol
0.8 G TID in mild to moderately active
Ulcerative Colitis --
BZUC – 3003
Salix Pharmaceutical,Inc.
2007
9. A phase 3, open-label study to assess
the long-term safety of TAK-390MR (60 mg QD and 90 mg QD)
incorporating Amendment
change No. 1 and 2 in patients with Gastroesophageal
Disease (GERD).
TAP Pharmaceutical Products Inc.
2006
10. A phase 2, Multi-center, Randomized,
double-blind, placebo controlled study to assess the efficacy
and safety
of three different doses (275, 550 and 1100 Mg) of Rifaximin
administered BID for either two or four weeks in
the treatment of patients with diarrhea associated irritable
bowel syndrome.
Salix Pharmaceutical, Inc. - RFIB-2001
2007
11. A randomized, double blind, placebo controlled, Multicenter,
phase III study of Rosuvastatin (Crestor) 20 MG
in the primary prevention of Cardiovascular events among
patients with low levels of LDL-Cholesterol
and elevated C reactive protein.
AstraZenica
2006
12. A Multicenter, randomized, double blind, Placebo controlled
Trial to evaluate the use of Mesalamine Pellet
Formulation 1.5G QD to maintain the remission from mild to
moderate Ulcerative Colitis 3004
Parexel Salix Pharmaceutical, Inc.
2006
13. A Multicenter, randomized, double blind,
Placebo controlled Trial to evaluate the safety and efficacy of
new
tablet formulation and dosing regimen of Balsalazide Disodium
3.3 G BID Versus placebo in mildly to
Moderately active Ulcerative Colitis. 3002
Parexel, Salix Pharmaceutical,
Inc.
2006
14. A Multicenter, open label study, treatment
Extension Trial to Evaluate the long-term safety and
tolerability of Mesalamine pellet formulation maintain
remission in mild to Moderately active Ulcerative
Colitis 3005.
Parexel Salix Pharmaceutical, Inc.
2006
15. A phase III study to evaluate the efficacy
and safety of TAK-390MR(60 mg QD and 90 mg QD) and an
active Comparator, Lansoprazole (30mg QD) on healing of
Erosive Esophagitis Grade c&D only.
Tap
Pharmaceutical
2006
16.- A phase III study to evaluate the efficacy and safety of
TAK-390MR (30 mg QD and 60 mg QD) as
compared to placebo on symptoms relief in subjects with
symptomatic Non Erosive Gastroesophageal
Reflux Disease (GERD) protocol T-GD05-137
incorporating Amendment dated 23 March 2006 (CRRI 0406006)
Tap
Pharmaceutical
2006
17. A Multi-center, open label trial to evaluate the long term
safety and tolerability of a New Balsalazide Disodium
Tablet formulation in patients with mild to
Moderately Ulcerative Colitis BZUC3005
Parexel Salix Pharmaceutical,
Inc.
2006
18. A phase III, Multicenter, randomized, double blind study, placebo controlled,
parallel- arm study of the efficacy
and safety of OPC-6535 tablets in the treatment
of subjects with active Ulcerative Colitis
Otsuka Maryland research
Institute
2005-2006
19. A phase IIb,
multicenter, randomized, double blind, placebo
controlled, parallel group, dose ranging study in
subjects with Functional Dyspepsia.
2005-2006
20. A. prospective, multicenter, open label, comparative,
efficacy study of Pegasys plus Copegus in treatment-naïve
Latino patients with Chronic Hepatitis C-Genotype 1,
as compared to treatment-naïve Non-Latino Caucasian
patients with Chronic Hepatitis
C-genotype 2006
21. A phase III study to evaluate the efficacy and safety of
TAK-390MR (60 mg QD and 90 mg QD) compared to
placebo on Symptom relief in subjects with symptomatic
Non-Erosive Gastroesophageal Reflux Disease (GERD).
TAP
Pharmaceutical 2006
22. A Multicenter, randomized, double blind, Placebo controlled
Trial to evaluate the safety and efficacy of new
tablet formulation and dosing regimen of
Balsalazide Disodium 3.3 Grams BID Versus placebo in mildly
to
Moderately active Ulcerative Colitis - 3002
Parexel Salix Pharmaceutical,
Inc 2006
23. A Double-Blind
placebo-controlled, Randomized, multicenter study to investigate
the safety of and efficacy
of 2mg TID of Cilansetron over 12 weeks in
diarrhea predominant Irritable Bowel Syndrome subjects.
Quintiles/Solvay
Quintiles
2002 - 2003
(Phase III, Goal 10, Screened 27, Enrolled 15 )
24. A 24 weeks Randomized, open label study of Healthcare
Resource use, quality of life
and productivity with Alosetron 1 mg twice daily versus
traditional therapy in females
with non-constipated Irritable Bowel Syndrome.
Quintiles /Glaxo Wellcome
2000
(Phase III, Goal 6, Screened 12, Enrolled 6 ) |
