Completed Trials

Cumberland Research Associates has completed numerous research trials in a wide variety of fields.

03/16 – 2/17 Second Phase 3, Randomized, 12 Week, Double Blind, Placebo Controlled  Study of the Safety and Efficacy of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IBS-C).

02/16 – 3/17 – A 12 Week, Randomized, Double-blind, Double-dummy, Placebo controlled with a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C).

02/16 – 3/17 – A 26 Week, Randomized, Double-blind, Double-dummy, Placebo Controlled with a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C).

12/15 – 12/16 – A Phase 2b, Randomized, Double-blind, Double-dummy, Placebo controlled, Parallel-group, Dose-range-finding Study of Two Delayed Release Formulations   of Linaclotide Administered Orally for 12 Weeks to Patients with Irritable Bowel Syndrome with Constipation.

07/15 – 2/2017 – A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks In Direct-Acting Antiviral-Experienced Subjects with Chronic HCV Infection.

10/15 – 2/17A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naïve Subjects with Chronic HCV Infection.

07/15 – 11/16 – A Randomized, Double-Blind, Multicenter Study To Explore The Effect Of GED-0301 On Endoscopic And Clinical Outcomes In Subjects With Active Crohn’s Disease.

03/15 – 9/16A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients with Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis.

02/15 – 12/16A Randomized, Double-blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Lubiprostone in Adult Subjects with Mixed or Un-subtyped Irritable Bowel Syndrome (IBS-M/IBS-U).  

01/15 – 2/17A Phase 2, Global,Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects with Chronic Non-Genotype 1 HCV Infection.  

01/15 – 2/17A Phase 2, Global,Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects with Chronic Genotype 1 HCV Infection.  

12/14 – 2/17An Open Label Study to Evaluate The Efficacy And Safety Of Sofosbuvir/GS-5816 Fixed Dose Combination With Ribavirin For 24 Weeks In Chronic HCV Infected Subjects Who Participated In A Prior Gilead Sponsored HCV Treatment Study.

11/14 – 2/16A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide (72 ug or 145 ug) Administered Orally for 12 Weeks to Patients with Chronic Idiopathic Constipation.  

11/14 – 3/17 – A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease.   

10/14 – 10/15A Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 ( a Low Volume Bowel Cleansing Solution) versus a Trisulfate Bowel Cleansing Solution using a 2-Day Split-Dosing Regimen in Adults.  

09/14 – 10/15A multi-center, randomized, double-blind study to compare the efficacy and safety of cadazolid versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).  

07/14 – 12/15Collection of Plasma and Serum Samples From Individuals Initiating Therapy With Sofosbuvir for Chronic Hepatitis C Virus Infection for the Clinical Evaluation of the Aptima HCV Quant Dx Assay.

07/14 – 1/16A Prospective Observational Study to Examine Patient Characteristics, Health Care Management, and Effectiveness Among HCV Patients Treated With Simeprevir at Various Practice Settings.  

04/14 – 5/15A 12-Week Double-Blind, Randomized, Placebo-Controlled, Parallel Group Phase III Study, Followed By A 4-Week Randomized Withdrawal Period To Evaluate The Efficacy And Safety Of Oral Ibodutant 10 MG Once Daily In Female Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D).  

03/14 – 9/16 –  Clinical Study To Evaluate The Efficacy And Safety Of Metoclopramide Nasal Spray In Men With Symptoms Associated With Diabetic Gastroparesis.  

03/14 – 9/16A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Study To Evaluate The Efficacy And Safety Of Metoclopramide Nasal Spray In Women With Symptoms Associated With Diabetic Gastroparesis.

01/14 – 7/15A Multicenter, Open-label, Safety and Tolerability Extension Trial of 5 mg and 10 mg Elobixibat Daily in the Treatment of Chronic Idiopathic Constipation.  

10/13 – 03/14Safety, antiviral effect and pharmacokinetics of BI 207127 in combination with BI 201335 and with or without ribavirin for 4, 16, 24, 28 or 40 weeks in patients with chronic HCV genotype 1 infection (randomized Phase Ib/II).   

07/13 – 12/16A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection.  

07/13 – 08/15A 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 Early Decompensated Liver Cirrhosis.

06/13 – 03/14A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IBS-C).  

06/13 – 06/14A Double-blind, Randomized, Placebo-controlled, Phase 3 Trial in Patients with Chronic Idiopathic Constipation to Demonstrate the Efficacy and Safety of Elobixibat 5 mg and 10 mg for 26 Weeks.  

04/13 – 05/14A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin for 8 Weeks and Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Treatment-Naïve subjects with Chronic Genotype 1 HCV Infection.  

04/13 – 10/14A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment Experienced Subjects with Chronic HCV Infection.  

04/13 – 09/14A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Naïve Subjects with Chronic HCV Infection.  

04/13 – 10/14A Randomized Study to Evaluate the Safety and Efficacy of IDX719 in Combinations with Simeprevir and/or TMC647055/Ritonavir with or without Ribavirin for 12 Weeks in Subjects with Chronic Hepatitis C Infection.  

01/13 – 05/14A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin for 12 and 24 Weeks in Treatment-Experienced Subjects with Chronic Genotype 1 HCV Infection.  

11/12 – 12/14A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered with Ribavirin (RBV) in Treatment-Experienced Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II).  

09/12 – 06/14A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin for 12 and 24 Weeks in Treatment-Naïve Subjects with Chronic Genotype 1 HCV Infection.

09/12 – 07/13A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Evaluate Efficacy of a Novel Selective 5-HT4 Receptor Agonist, SSP-002358 Taken in Addition to a Proton Pump Inhibitor in Subjects with Gastroesophageal Reflux Disease With Persistent Regurgitation with or without Heartburn while on Proton Pump Inhibitor Therapy.

07/12 – 09/14A Phase II Multicenter, Parallel-Group, Randomized, Dose-Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following 12 Weeks of Oral Administration of GSK2336805 With Pegylated Interferon and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 or 4 Hepatitis C Infection.

06/12 – 09/13A Phase 3B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks to Patients with Chronic Constipation and Prominent Abdominal Bloating at Baseline.

05/12 – 08/14 A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome.

11/11 – 12/12A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Evaluation of the Efficacy and Safety of Once-Daily Administrations of TZP-102 for the Treatment of Symptoms Associated with Diabetic Gastroparesis.  

10/11 – 12/14A Phase 4, Randomized, Active Comparator, Open label, Multicenter Study to Assess the Safety and Efficacy of Osmoprep Tablets Versus Halflytely and Bisacodyl Tablets Bowel Prep Kit For Colon Cleansing.

10/11 – 12/14A Randomized, open-label, Multi-center Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics, of ABT-450 with Ritonavir (ABT-450/r) in combination with ABT-267 and/or ABT -333 with and without Ribavirin (RBV) for 9, 12 or 24 weeks in Treatment-Naïve and Null Responder Subjects with Genotype 1 Chronic Hepatitis C Virus Infection.

09/11 – 10/13Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer: DeeP-C Study.

08/11 – 10/14A Randomized, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of different Regimens of MK-5172 When Administered Concomitantly with Peginterferon Alfa-2b and Ribavirin in Treatment-Naïve Patients with Chronic Genotype 1 Hepatitis C Virus Infection.

07/11 – 9/14A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy using Combinations of Oral Antivirals (GS-5885, tegobuvir, and/or GS-9451) WITH Peginterferon Alfa 2a and Ribavirin in  Treatment Experienced Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.

04/11 – 7/13A Randomized, double-blind, placebo-controlled Trial of the efficacy and safety of DEB025/Alisporivir in combination with standard of care in hepatitis C genotype 1 treatment –naïve patients

02/11 – 5/13A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Induction Trial to Assess the Clinical Efficacy and Safety of NNC0142-0000-0002 in Subjects with Moderately to Severely Active Crohn’s Disease.

10/10- 3/14 – A Randomized, Open label, Multicenter, Dose and Duration Finding Study To Evaluate the Sustained Virologic Response of the HCV Protease Inhibitor Danoprevir (RO5190591) Boosted with Low Dose Ritonavir (danoprevir/r) In Combination with Pegasys and Copegus versus Pegasys and Copegus Alone in Treatment-Naïve Patients with Chronic Hepatitis C Genotype 1 or 4 Virus Infection.

 6/10- 2/13 –  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.  

4/10- 4/13A 12-week, Randomized, Double-Blind, Placebo-Controlled Study of Asimadoline in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome.  

4/10- 2/13A Phase 3,Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess the Efficacy and Safety of Budesonide Foam (2mg/25ml QD for 4 Weeks) Versus Placebo in subjects with Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis..

03/10 – 10/10A Phase 2 Trial of NOV-205 in Chronic Viral Hepatitis C Subjects (Genotype 1) who have failed Treatment with Pegylated Interferon and Ribavirin.

1/10 – 7/10A Dose-Response Efficacy and Safety Study of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects with Gastro esophageal Reflux Disease (GERD) who are Incomplete Responders to a Proton Pump Inhibitor (PPI).

1/10–5/13A Phase 3 Study, Boceprevir and Peg interferon/Ribavirin for the treatment of Chronic Hepatitis C in Treatment-Naive Subjects: A Comparison of Erythropoietin use Versus Ribavirin Dose Reduction for the Management of Anemia.

10/09-11/10A Phase2, Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin in Subjects with Genotype 1 Chronic Hepatitis C Infection.

10/09-5/10A Randomised, double-blind, placebo controlled, multi-centre phase IIb dose finding study to assess the effect on GERD symptoms, safety and tolerability during four weeks treatment with AZD3355 in doses 60mg, 120mg, 180mg and 240mg bid as add-on treatment to a PPI in patients with GERD that are partial responders to PPI treatment.

7/09 – 5/10A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide Administered Orally for 12 Weeks followed by a 4 week randomized withdrawal period in patients with Irritable Bowel Syndrome With Chronic Constipation.

6/09-8/10 A Multicenter, Randomized,  Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Clinical Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Subjects with Gastro paresis.

11/08 – 02/09A Randomized Double-Blind Parallel Study of Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastro esophageal Reflux Disease (GERD).

11/08 – 2/13an Open-label, Long-term Safety Study of Oral Linaclotide Administered to Patients with Chronic Constipation or Irritable Bowel Syndrome with Constipation.

11/08 – 5/10A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide Administered Orally for 12 Weeks in Patients with Chronic Constipation.

12/08 – 5/10A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects with Chronic Hepatitis C Genotype 1.

09/08 – 03/09A Randomized Double-Blind Parallel Study of Rabeprazole Extended Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastro esophageal Reflux Disease (GERD)

09/08 – 03/09A Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastro esophageal Reflux Disease (GERD)

04/08-02/09Validation of patient reported outcome measures for the assessment of GERD symptoms and their subsequent impact on patients with a partial response to PPI treatment in a two part multi-center phase IIA study including a four week randomised, double-blind, placebo-controlled, parallel-group treatment phase with AZD3355, 65mg bid as add-on treatment to a PPI.

09/08-01/09Single Blind, Controlled, Randomized Prospective Trail to Evaluate the Effectiveness of FM-602 as Bowel Preparation Before Colonoscopy.

05/08-01/09 A Randomized, Double-Blind, Double- Dummy, Parallel Group, Phase 3 Efficacy and Safety Study of CGT-2168 Compared With Clopidogrel to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease

05/08-03/10Efficacy and Safety Study Of new oral budesonide-MMX (CB-01-02) 6mg and 9mg 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 2400mg.

04/08-3/10A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination with Peg interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naïve Subjects with Genotype 1 Chronic Hepatitis C.

04/08-08/08A Randomized, Double-Blind, Parallel-Group, Multicenter, Phase III Study To asses the effect of Esomeprazole 20 and 40 MG OD Versus Placebo on the Occurrence of Peptic Ulcers during 26 weeks in subject on continuous Low Dose ASA

03/08-07/08A Phase II, Randomized, Adaptive Design, Multicenter, Parallel Group, Placebo-controlled, 58-day, Dose-ranging Study of ATI-7505 in Patients with Postprandial Distress Syndrome

02/08-07/08A Phase II, Randomized, Placebo-controlled Study of ATI-7505 in Patients with Chronic Idiopathic Constipation

12/07-03/09A Double Blind, Randomized, Placebo-Controlled Phase 2B Study of 100, 200, and 300 mg BID Dextofisopam in female outpatients with IBS

12/07-2/10A Phase III, Randomized, Double-Blind, Dose-Response, Stratified, Placebo Controlled Study Evaluating the Safety and Efficacy of SPD476 versus  Placebo over 104 weeks in the Prevention of Recurrence of Diverticulitis.

10/07-05/08A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Range-Finding, Parallel-Group, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients with Chronic Constipation

06/07-12/07A phase 2 Double-Blinded Study to Evaluate the Safety and Efficacy of Ilaprazole (5mg QD, 20mg QD, 40 mg QD) and an Active Comparator, Lansoprazole (30mg QD) on Healing of Erosive Esophagitis Incorporating Amendment No. 1

05/07-06/08A randomized, Double-Blinded, Phase 3 Study of the Efficacy and Safety of HZT-501 in Subjects Requiring NSAID Treatment

04/07-02/08 A randomized, double-blinded, parallel-group, multicenter, phase III study to assess the effect of esomeprazole 20 and 40 mg versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid (ASA)

03/07-12/07Efficacy and Safety if Daily Infergen/Ribavirin in Patients with Chronic Hepatitis C Virus Infection Who Were Partial Responders after Peg Interferon Alfa/Ribavirin Therapy

01/07-02/09Randomized, Multicenter, Double-Blinded, Phase IV Study Evaluating the Efficacy (as measured by Sustained Virological Response) and Safety of 360mg Induction Dosing of Pegasys in Combination with Higher Copegus  Doses in Treatment-naïve Patients with Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Baseline Body Weight Greater than or Equal to 85kg

09/06-10/07 A 12 Week, Randomized, Double-Blinded, Dose- Ranging, Placebo- Controlled of Asimadoline in Subjects with Irritable Bowel Syndrome

08/06-03/08A Partially-Blinded, Randomized, Parallel-Group Study to Evaluate the Potential Pharmacokinetics and Pharmacodynamic Interactions Between Valopicitabine and Ribavirin when Administered in Combination with Pegylated Interferon Alfa-2a in Treatment-Naïve Patients with Chronic Hepatitis C

12/05-01/06 Study drug versus Marketed HalfLytely with Bisacodyl tablets bowel prep kit for colon cleansing: An investigator-blinded, randomized, multi-center trial.

05/05-02/06Randomized, db, pc study of Study Drug in the treatment of functional diarrhea.

05/04-01/06Multi-center, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study of Study Drug in subjects with functional dyspepsia.  

06/05-12/05Randomized, db, pc, pg, multicenter study to evaluate the efficacy and safety of a 4 week treatment with Study Drug for the healing of acute erosive esophagitis.

11/04-05/05 A study of merimepodib in combo with peg interferon alpha-2a (pegasys) and ribavirin in subjects with chronic genotype 1 hepatitis c non-responsive to prior therapy with peg interferon alpha and ribavirin.

09/04-11/04 Colon cleansing efficacy and safety of study drug. An investigator-blinded, randomized, multicenter trial.

12/03-03/04 Safety, efficacy, and dose ranging study of drug in subjects with constipation. Principal Investigator.

11/03-04/04Symptom relief in patients suffering from GERD grade A to D according to LA Classification treated with study drug.               

08/03-04/04 An open-label, long-term safety study to assess the safety of study drug in subjects with GERD.

06/03-12/04A 12 week, randomized, db, placebo controlled, parallel-group study to assess the safety and efficacy of study drug in female subjects with severe diarrhea-predominant IBS who have failed conventional therapy.

05/03-06/03A multicenter, randomized, double-blind, placebo-controlled efficacy study comparing 4 weeks of treatment in patients with heartburn and sleep disturbance associated with GERD.  

03/03-12/03Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group comparison of remission rates for once daily treatment with the study drug for 6 months in subjects whose EE has been healed.

03/03-06/03A multicenter, randomized, double-blind, double-dummy, parallel-group efficacy study comparing 8 weeks of treatment with study drug for the healing of erosive esophagitis in patients with moderate or severe symptoms.

11/02-05/03A randomized, double-bind, multi-center comparison study of balsalazide versus mesalamine in a subset of subjects with mild to moderate UC who previously failed high-dose mesalamine therapy.  

09/02-09/04A pilot study to evaluate study drug in patients with chronic hepatitis C experiencing fatigue undergoing combination therapy with PEG-Intron and Rebetol.

08/02-10/02An 8 week, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate efficacy and safety of SB223412 in subjects with IBS.  

04/02-08/02A double-blind, randomized, placebo-controlled, dose ranging study to assess safety, efficacy, and tolerance of study drug in subjects with GERD with prominent regurgitation.

02/02-03/03A double-blind, placebo-controlled, randomized, multi-center study to investigate the safety and efficacy of cilansetron over 12 weeks in diarrhea-predominant IBS subjects.

12/01-09/04A Ten-Week Randomized, Double-Blind, Placebo-Controlled Study of study drug in Patients with Diarrhea Predominant IBS.

12/01-04/03A 12-week, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel Group, Multicenter Study of the Safety and Efficacy of study drug in female patients with Constipation-Predominant Irritable Bowel Syndrome.

05/01-02/03A comparative efficacy and safety study of esomeprazole magnesium delayed-release capsules versus ranitidine for the healing of NSAID-associated gastric ulcers when daily NSAID use is continued.  

05/01-10/02A comparative efficacy and safety study of esomeprazole magnesium delayed-release capsules versus placebo for the prevention of gastric ulcers associated with daily NSAID use in patients at risk.  

05/01-05/02A comparative efficacy and safety study of esomeprazole magnesium delayed-release capsules versus placebo for the healing of NSAID-associated gastric ulcers when daily NSAID use is discontinued.  

01/01-02/03A prospective, randomized, multicenter, open label comparative safety study of study drug treatment in patients with chronic Hepatitis C.

09/00-06/01A prospective, randomized, multi-center, open-label comparative safety study of Pegasys vs. Pegasys plus Ribavirin treatment in patients with Chronic Hepatitis C.  

09/00-01/01A double-blind, placebo-controlled, randomized, multi-center study to investigate the safety and efficacy of cilansetron in non-constipated subjects with established IBS.  

09/00-12/01Rebetron combination therapy compliance assessment program.  A prospective, comparative evaluation of the Be In Charge Program and its effect on patient compliance and treatment outcome.  

08/00-12/01A comparative efficacy study of esomeprazole magnesium and lansoprazole in patients with erosive esophagitis.  

06/00-11/02Randomized trial of Pegylated Interferon Alpha-2b and Ribavirin for the treatment of Chronic Hepatitis C in African Americans and Caucasians.  

06/00-06/01Randomized trial of Pegylated Interferon Alpha- 2b and Ribavirin vs. Pegylated Interferon alone in patients with Hepatitis C who have failed standard therapy.

04/00-09/00Daily vs. thrice weekly interferon in combination with ribavirin for patients with Chronic Hepatitis C Infection who have not been previously treated.

04/00-09/00Daily vs. thrice weekly interferon in combination with ribavirin for patients which Chronic Hepatitis C Infection who have relapsed or failed prior interferon therapy.

11/99-03/00A clinical trial to evaluate the timing of symptom relief and the change in symptom severity in a general population of patients with a confirmed diagnosis of erosive esophagitis who are treated with ACIPHEX for 8 weeks.  

09/99-10/00A 24 week randomized, open-label study of health care resource use, quality of life and productivity with Alosetron vs. traditional therapy in females with IBS whose predominant bowel symptom is diarrhea.  

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