Clinical Trials

Clinical Research

Houston Digestive Diseases Clinic is composed of full time Gastroenterologist working as principle investigator and experienced staff offers new and innovative therapeutic modalities. We participate in clinical research in order to offer our patients a variety of cutting-edge treatment options and to assist the pharmaceutical industry in developing better medications for our patients and our community. Every study that we complete brings us one step closer to more successfully managing our patient’s diseases and symptoms. Our research office is designed for and equipped to handle significant amounts of data produced by the enrolling studies. All of our research staff, and our sub-investigators, are committed to conduct quality and successful clinical trials and maintaining GCP standards.

CURRENT ENROLLING STUDIES:

Salix Pharmaceuticals RFHE4044: Hepatic Encephalopathy Currently Enrolling
A Multicenter, Randomized, Open-Label, Acctive-Controlled, Trial to Evaluate The Safety and Efficacy of Rifaximin 550MG With And Without Lactulose in Subjects With A History of Recurrent Overt Hepatic Encephalopathy. 2013

Santarus Inc. C2011-0401: Ulcerative Colitis Study Currently Enrolling
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen 2012

Salix Pharmaceuticals RFIB 3053: IBS-Diarrhea Currently Enrolling
A Study To Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 MG TID in Subjects with Irritable Bowel
Syndrome with Diarrhea (IBS-D) 2012

NHLDI Currently Enrolling
CIRT Cardiovascular Inflammation Reduction Trial BWH1-12-468 2013
Patients suffering from diabetes type II metabolic syndromes and had an episode of myocardial infarction in last 5 years

PAST CLINICAL TRIALS CONDUCTED AT OUR SITE

AbbVie P11-282 Ulcerative Colitis Moderate to SEVERE Currently Enrolling
A long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA (Adalimumab) in Patient with Moderately to Severely Active Ulcerative Colitis 2013

Salix Pharmaceuticals RNLC2131: Early Liver Cirrhosis Currently Enrolling
A Randomized, Double-Blind, Placebo-Controlled, Dose-ranging, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets For the Prevention of Complications in Subjects with Compensated Liver Cirrhosis 2013

Ventrus Biosciences VEN307-AF-001: Anal Fissure
A Phase IIIB, Randomized, Double-Blind, Placebo-Controlled, Parallel-Treatment Group, Multicenter Efficacy and Safety Study of Topical Diltiazem Hydrochloride 2% Cream in Subject with Anal Fissures 2013

Altheus Therapeutics, Inc ZA-201 MILD to Moderate Ulcerative Colitis
A Phase II double-blind, randomized, comparator-controlled study of the safety and efficacy of Zoenasa™ Rectal Gel(mesalamine plus N-acetylcysteine) in subjects with left-sided ulcerative colitis. 2013

Novella BUCF3002: Ulcerative Proctitis/Ulcerative Proctosigmoiditis Study
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Budesonide Foam (2mg/25ml BID for 2 weeks, Followed by 2mg/25ml QD for 4 weeks) Versus Placebo in Subjects with Active Mile to Moderate Ulcerative Proctitis of Proctosigmoiditis. 2012

Dr.Falk Pharma SAG-51/DIV: Diverticulitits Study
Double-blind, dose-response, randomized, placebo-controlled, parallel group, multi-centre phase III clinical study of the efficacy and tolerability of mesalzine granules vs. placebo for the prevention of recurrence of diverticulitis. 2012

Santarus Inc. C2011-0401: Ulcerative Colitis Study
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen 2012

Salix Pharmaceuticals RFIB 3053: IBS-D
A Study To Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 MG TID in Subjects with Irritable Bowel Syndrome with Diarrhea (IBS-D) 2012

Ventrus Biosciences VEN309-Hem-SE3-001: Internal Hemorrhoid Study
A Phase3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Treatment Group, Multicenter Efficacy and Safety Study of Intra-Anal Application of Iferanserin (10mg) as a 0.5% ointment in Subjects with Symptomatic Internal Hemorrhoids 2012


PPD Therapeutics: 27018966IBS2001 IBS-D

A Randomized, Double-blind, Placebo-controlled, Parallel group, Dose ranging, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients with Irritable Bowel Syndrome with Diarrhea 2011


Gilead Sciences, Inc. GS-9190, GS-9256 2010
HCV treatment naïve study

Clinsys Clincial Research G-008-01 Enrollment Closed Mild to moderate Active Ulcerative Colitis A Randomized, Double-Blind, Placebo-Controlled, Multi-center Study of a One Gram/60 mL Mesalamine Rectal Suspension in the Treatment of Mild to Moderate Active Distal Ulcerative Colitis


Shire Protocol SPD476-409:

Longterm Safety Study Ulcerative Colitis In remission
Phase 4 study to evaluate the Remission Status on the Ability to Maintain or Achieve Clinical and
Endoscopic Remission During a 12 month, Long-term Maintenance Phase with 2.4g/day MMX
Mesalamine/mesalazine Once Daily in Adult Subjects with Ulcerative Colitis.


COSMO CB-01-02/01 Active Ulcerative Colitis

Efficacy and safety of new oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablet formulations in patients with mild or moderate, active ulcerative colitis. A multicenter, randomized, double-blind, double dummy comparative study versus placebo, with an additional reference arm evaluating Asacol® 2400 mg.


Gilead GS-US-196-0103 Hepatitis C Virus Trial

Study A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Comparing 24 or 48 Weeks of GS-9190, in Combination with Peginterferon Alfa 2a and Ribavirin, to 48 Weeks of Peginterferon Alfa 2a and Ribavirin for the Treatment of Genotype-1 Chronic Hepatitis C Virus (HCV) Infection (GS-US-196-0103)


LIN-MD-31 IBS-C

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Linaclotide Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients with Irritable Bowel Syndrome with Constipation


LIN-MD-02 IBS C-C

Enrolling as an extension study Protocol Title: An Open-Label, Long-Term Safety Study of Oral Linaclotide Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome with Constipation.


A Phase 2b, Randomized, Double-Blind
, Placebo-Controlled Trial Comparing 24 or 48 Weeks of
GS 9190, in Combination with Peginterferon Alfa 2a and Ribavirin, to 48 Weeks of Peginterferon
Alfa 2a and Ribavirin for the Treatment of Genotype-1 Chronic Hepatitis C Virus (HCV)
Infection

2008


302 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). 2008
Eisai Pharmaceuticals


303 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). 2008
Eisai Pharmaceuticals


E3810-G000-306: A Randomized Double-Blind Parallel Study
of Rabeprazole Extended-Release
50 mg versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux
Disease (GERD) 2008

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.Colitis. 2008

COSMO CB-01-02/01 Active Ulcerative Colitis Efficacy and safety of new oral budesonide-
MMX™ (CB-01-02) 6 mg and 9 mg extended release tablet formulations in patients with mild or
moderate, active ulcerative colitis. A multicenter, randomized, double-blind, double dummy
comparative study versus placebo, with an additional reference arm evaluating Asacol® 2400 mg. 2008

LIN-MD-01 Protocol Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-
Group Trial of Linaclotide Administered Orally for 12 Weeks in Patients with Chronic Constipation 2008

LIN-MD-02- Protocol Title: An Open-Label, Long-Term Safety Study of Oral Linaclotide
Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome with
Constipation.

LIN-MD-31-Protocol Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled,
Parallel-Group Study of Linaclotide Administered Orally for 12 Weeks Followed by a 4-Week
Randomized Withdrawal Period in Patients with Irritable Bowel Syndrome with Constipation

A Multi-center Randomized, Double blind study to compare the efficacy, safety and tolerability of Rabeprazole ER 50 mg with placebo in subjects with symptomatic Gastroesophageal reflux disease (sGERD).
EISAI Medical Research Inc.

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

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

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

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.

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.

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.
Bayer –

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

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. 2006-2007

A phase 2 double blind study to evaluate the safety and efficacy of Illaprazole ( 5 MG,
2 MG and 40 MG QD) on healing of Erosive Esophagitis).
TAP Pharmaceutical Products Inc.

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

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

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

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

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. 2006
AstraZenica

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

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


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

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

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 Gastroe sophageal Reflux Disease (GERD) protocol T-GD05-137
incorporating Amendment dated 23 March 2006 (CRRI 0406006)
Tap Pharmaceutical 2006

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

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

A phase IIb, multicenter, randomized, double blind placebo controlled, parallel
group, dose ranging study in subjects with Functional Dyspepsia.
2005-2006

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

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

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


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 )

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 )

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