Houston Digestive Diseases Clinic is composed of full time Gastroenterologist working as principle investigator , ten sub-investigators and experienced staff offers new and innovative therapeutic modalities to is extensive and variedWe  participate in clinical research in order to offer our patients a variety of cutting-edge treatment options andto 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.

Study Coordinator	Gretchen Daulton
Subinvestigatrs
Internal Medicine	Family Practice
Alex Nguyen, MD	Huong Le, MD	Asaf Qadeer, MD	Blandina Sison, MD
Quac Le, MD	Dian Malone, MD	Jose Sagbini, MD
	Hiedi Nashed, MD

ENROLLING STUDIES:
1.Novella BUCF3002  Ulcerative Proctitis/Ulcer Proctosigmoiditis  Study.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and
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.                                  2010

2. 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.        2010

3. PPD Theraputics: 27018966IBS2001 -               IBS-D                 Enrollment opening soon
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                        2010

4.  Gilead Sciences, Inc.  GS-9190, GS-9256                                                                                                                                2010
     HCV naive study

5.Quintiles                                                                                                      Enrollment opening soon
A double blind Randomized and Parallel group phase II dose finding study in subjects undergoing
Elective Colonoscopy, evaluating the level of AZD3043 compared to a standard dose of Propofol.     Fall 2010

6.Clinsys Clincial Research   G-008-01                                   Enrollment opening                Fall 2010
 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                                                                                                                                      

7. Shire  Protocol SPD476-409:                                          Enrollment opening                                                             May 2010          
 Long term 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 Maintenanc Phase with 2.4g/day MMX Mesalamine/mesalazine Once Daily in Adult Subjects with Ulcerative Colitis                                      2010                                       

CLINICAL TRIALS CONDUCTED AT OUR SITE.
8. COSMO CB-01-02/01  Active Ulcerative Colitis                  Enrollment closed
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                                               2009-2010

9 Gilead  GS-US-196-0103  Hepatitis C Virus Trial                          Enrollment closed
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)                                                    2009-2010

10..LIN-MD-31            IBS-C                                                                 Enrollment Closed
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
                                                                                                                                                    2009-2010
11. .  LIN-MD-02     IBS C-C                                                          Enrollment Closede
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.                           2009-2010

12. 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.                                                                                    2009

13  302  A Randomized Double-Blind, Parallel Study of Rabeprazole Extended Release 50mg Versus Esomeprazole 40 mg for healing of and symptomatic relief of Moderate to severe Erosive gastroesophageal Reflux Disease (GERD).                 
 Eisai Pharmaceutical                                                                                                                          2008

14,303 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 Pharmaceutical

15. 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

16.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       

17,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

18,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                      

19. 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.

20. 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

21. 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).

22 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                                                                                

23,     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

24, 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

25.Clin-AG1003-007 An open label, safety study of AGI-003 ((Arverapamil) iin treatment of Irritable Bowel     
      Syndrome with Diarrhea (IBD-D).
     AGI-Therapeutic Research Ltd

26.24 weeks double blind, Ibuprofen (800 MG PO TID) controlled to evaluate a combination of NSAID and
  omatidine 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.

27.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 -
 
28. 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
Quintiles, Inc.- Alizyme Therapeutic                                 2007

29. A Multicenter, open label study, treatment Extension Trial to Evaluate the long-term safety and tolerability of Mesalamine pellet formulation maintain remission in mild toModerately active Ulcerative Colitis 3005.
Parexel Salix Pharmaceutical, Inc.                                    2006-2007

30. 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                                     2006-2007

31, 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

32, 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

33,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

34, 34. 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

35,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

36, . A Multicenter, randomized, double blind, Placebo controlled Trial to evaluate the use of Mesalamine PelletFormulation 1.5G QD to maintain the remission from mild to moderate Ulcerative Colitis  3004
Parexel Salix Pharmaceutical, Inc.                                              2006

37, A Multicenter, randomized, double blind, Placebo controlled Trial to evaluate the safety and efficacy of newtablet formulation and dosing regimen of Balsalazide Disodium 3.3 G BID Versus placebo in mildly to Moderatelactive Ulcerative Colitis. 300Parexel, Salix Pharmaceutical, Inc.                                           2006

38, A Multicenter, open label study, treatment Extension Trial to Evaluate the long term safety and tolerability Mesalamine pellet formulation maintain remission in mild to Moderately active Ulcerative Colitis 3005Parexel Salix Pharmaceutical, Inc.                                            2006

39. A phase III study to evaluate the efficacy and safety of TAK-390MR(60 mg QD and 90 mg QD) and an activComparator, Lansoprazole (30mg QD) on healing of Erosive Esophagitis Grade c&D only. Tap Pharmaceutical                                                                 2006

40.A phase III study to evaluate the efficacy and safety of TAK-390MR (30 mg QD and 60 mg QD) as comparedto 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

41,A Multi-center, open label trial to evaluate the long term safety and tolerability of a New Balsalazide DisodiumTablet formulation in patients with mild to Moderately Ulcerative Colitis BZUCParexel
Salix Pharmaceutical, Inc.                                                             2006

42, 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 subjects with active Ulcerative Colitis.
Otsuka Maryland research Institute                                                      2006

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

44, A. prospective, multicenter, open label, comparative, efficacy study of Pegasys plus Copegus in treatment-naïve Latino Patints with Chronic Hepatitis C-Genotype 1, as compared to treatment-naïve Non-Latino Caucasian patients with
Chronic Hepatitis C-genotype 1.                                                                                          2005-2006 

45, A phase III study to evaluate the efficacy and safety of TAK-390MR (60 mg  QD and  90 mg QD) compared to placon Symptom relief in subjects with symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD).
TAP Pharmaceutical                                                                                                          2005-2006

46, 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

47, A Double-Blind placebo-controlled, Randomized, multicenter study to investigate thr safety of and efficacy of 2mg
TID of Cilansetron over 12 weeks in diarrhea predominant Irritable Bowel Syndrome subjects.
Quintiles/Solvay Quintiles                                                                                                2002 - 2003

48, A 24 weeks Randomized, open label study of Healthcare Resource use, quality of life and productivity with Alosetro 1 mg twice daily versus traditional therapy in females with non-constipated Irritable Bowel  Syndrome
Quintiles /Glaxo Wellcome                                                                                                2000