Esophageal Diseases News

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||||||||||  propranolol / Generic mfg.
Trial completion:  PROPRANOLOL PLUS LIGATION REDUCES RECURRENCE OF ESOPHAGEAL VARICES? (clinicaltrials.gov) -  Jul 7, 2013
P4, N=100, Completed,  Sponsor: Federal University of S
Not yet recruiting --> Completed

|||||||||| Trial completion: Prospective Comparison of Large vs. Small Diameter Esophageal Stents for Palliation of Malignant Dysphagia (clinicaltrials.gov) - Jul 3, 2013
P1, N=100, Completed, Sponsor: Mayo Clinic
Not yet recruiting --> Completed Not yet recruiting --> Completed

||||||||||  Takecab (vonoprazan) / Takeda, Phathom Pharma
Trial completion:  Efficacy of TAK-438 Compared to Placebo in the Treatment of Non-Erosive Gastroesophageal Reflux Disease (clinicaltrials.gov) -  Jul 1, 2013
P3, N=827, Completed,  Sponsor: Takeda Pharmaceutical Company Limited
Not yet recruiting --> Completed Recruiting --> Completed

||||||||||  Istodax (romidepsin) / Astellas, BMS
Trial termination:  FR901228 in Treating Patients With Refractory Stomach Cancer or Gastroesophageal Junction Cancer (clinicaltrials.gov) -  Jun 30, 2013
P2, N=20, Terminated,  Sponsor: National Cancer Institute (NCI)
Recruiting --> Completed Suspended --> Terminated

||||||||||  7-Hydroxystaurosporine (UCN-01) / National Cancer Institute
Trial completion, Combination therapy, Metastases:  7-Hydroxystaurosporine and Irinotecan Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Triple Negative Breast Cancer (Currently Accruing Only Triple-negative Breast Cancer Patients Since 6/8/2007) (clinicaltrials.gov) -  Jun 30, 2013
P1, N=41, Completed,  Sponsor: National Cancer Institute (NCI)
Suspended --> Terminated Active, not recruiting --> Completed

||||||||||  brivanib alaninate (BMS-582664) / ZAI Lab
Trial completion, Metastases:  Phase II Study of Brivanib (BMS-582664) to Treat Multiple Tumor Types (clinicaltrials.gov) -  Jun 25, 2013
P2, N=597, Completed,  Sponsor: Bristol-Myers Squibb
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Trial completion, HEOR: Quality Of Life Outcomes Following Treatment for Esophageal Cancer (clinicaltrials.gov) - Jun 25, 2013
P=N/A, N=409, Completed, Sponsor: Memorial Sloan-Kettering Cancer Center
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Zolinza (vorinostat) / Merck (MSD)
Trial completion, Metastases:  Vorinostat, Irinotecan, Fluorouracil, and Leucovorin in Treating Patients With Advanced Upper Gastrointestinal Cancer (clinicaltrials.gov) -  Jun 25, 2013
P1, N=23, Completed,  Sponsor: Roswell Park Cancer Institute
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  esomeprazole / Generic mfg.
Enrollment open:  Efficacy of Proton Pump Inhibitor for Chronic Cough Caused by Gastroesophageal Reflux; Double-blind, Placebo-controlled, Randomized Clinical Trial (clinicaltrials.gov) -  Jun 24, 2013
P=N/A, N=132, Recruiting,  Sponsor: Yonsei University
Active, not recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Enrollment open: HRM RTSIO: Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD (clinicaltrials.gov) - Jun 20, 2013
P=N/A, N=20, Recruiting, Sponsor: University Hospital, Bordeaux
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting

||||||||||  BMS-833923 / BMS
Trial completion, Combination therapy, Metastases:  A Study of BMS-833923 With Cisplatin and Capecitabine in Inoperable, Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas (clinicaltrials.gov) -  Jun 19, 2013
P1, N=39, Completed,  Sponsor: Bristol-Myers Squibb
Not yet recruiting --> Recruiting Active, not recruiting --> Completed

|||||||||| Trial completion: Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy (clinicaltrials.gov) - Jun 17, 2013
P1/2, N=60, Completed, Sponsor: University of Aarhus
Active, not recruiting --> Completed Recruiting --> Completed

|||||||||| New P3 trial: Gastroesophageal Reflux Treatment in Scleroderma (clinicaltrials.gov) - Jun 13, 2013
P3, N=250, Recruiting, Sponsor: Khon Kaen University

|||||||||| Enrollment open: Compound Sodium Alginate Double Action Chewable Tablet Symptomatic Relief Study (clinicaltrials.gov) - Jun 12, 2013
P3, N=1100, Recruiting, Sponsor: Reckitt Benckiser Healthcare (UK) Limited
Recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Trial completion, HEOR: Quality-of-Life Assessment of Patients Who Have Cancer of the Esophagus (clinicaltrials.gov) - Jun 10, 2013
P=N/A, N=370, Completed, Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Not yet recruiting --> Recruiting Active, not recruiting --> Completed

||||||||||  esomeprazole / Generic mfg.
New P4 trial:  Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy (clinicaltrials.gov) -  Jun 9, 2013
P4, N=500, Recruiting,  Sponsor: Chang Gung Memorial Hospital

|||||||||| New P1/2 trial: Endoscopic Myotomy for the Treatment of Achalasia (Motility Disorder) of the Esophagus - POEM Procedure (clinicaltrials.gov) - Jun 6, 2013
P1/2, N=5, Recruiting, Sponsor: Massachusetts General Hospital

|||||||||| Enrollment change, Surgery: RESULT (REflux Surgery in Lung Transplantation) Preliminary Study Protocol (clinicaltrials.gov) - Jun 5, 2013
P=N/A, N=647, Completed, Sponsor: Duke University
Active, not recruiting --> Completed N=925 --> 647

|||||||||| New P3 trial: Compound Sodium Alginate Double Action Chewable Tablets 4-hour Esophageal pH Study in GERD Patients (clinicaltrials.gov) - Jun 5, 2013
P3, N=45, Completed, Sponsor: Reckitt Benckiser Healthcare (UK) Limited

|||||||||| Trial completion, Surgery: RESULT (REflux Surgery in Lung Transplantation) Preliminary Study Protocol (clinicaltrials.gov) - Jun 5, 2013
P=N/A, N=647, Completed, Sponsor: Duke University
N=925 --> 647 Recruiting --> Completed

||||||||||  Omegaven (omega-3 long-chain polyunsaturated fatty acids) / Fresenius Kabi
New P2 trial:  Study of Additive Omega-3 Fish Oil to Palliative Chemotherapy to Treat Oesophagogastric Cancer (clinicaltrials.gov) -  Jun 4, 2013
P2, N=45, Recruiting,  Sponsor: University Hospitals, Leicester

|||||||||| New P3 trial: Compound Sodium Alginate Double Action Chewable Tablet Symptomatic Relief Study (clinicaltrials.gov) - Jun 3, 2013
P3, N=1100, Recruiting, Sponsor: Reckitt Benckiser Healthcare (UK) Limited

|||||||||| IO biomarker: Epithelial Damage in GERD (clinicaltrials.gov) - Jun 2, 2013
P=N/A, N=30, Recruiting, Sponsor: Maastricht University Medical Center

||||||||||  Omegaven (omega-3 long-chain polyunsaturated fatty acids) / Fresenius Kabi
Enrollment open:  Study of Additive Omega-3 Fish Oil to Palliative Chemotherapy to Treat Oesophagogastric Cancer (clinicaltrials.gov) -  Jun 2, 2013
P2, N=45, Recruiting,  Sponsor: University Hospitals, Leicester
Recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Enrollment open, HEOR: Home Jejunostomy Feeding Following Esophagectomy/Gastrectomy (clinicaltrials.gov) - Jun 2, 2013
P=N/A, N=60, Recruiting, Sponsor: University Hospitals, Leicester
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting

||||||||||  ursodeoxycholic acid / Generic mfg.
Enrollment change:  Clinical Studies on Bile Acids in Barrett's Esophagus (clinicaltrials.gov) -  May 29, 2013
P=N/A, N=60, Active, not recruiting,  Sponsor: Department of Veterans Affairs
Not yet recruiting --> Recruiting N=120 --> 60

||||||||||  MK-2206 / Merck (MSD)
Enrollment closed, Metastases:  Akt Inhibitor MK2206 in Treating Patients With Advanced Gastric or Gastroesophageal Junction Cancer (clinicaltrials.gov) -  May 27, 2013
P2, N=64, Active, not recruiting,  Sponsor: National Cancer Institute (NCI)
N=120 --> 60 Recruiting --> Active, not recruiting

||||||||||  Avastin (bevacizumab) / Roche
Enrollment closed, Metastases:  XAGastric: Oxaliplatin, Capecitabine and Avastin for Metastatic Esophagogastric Adenocarcinoma (clinicaltrials.gov) -  May 27, 2013
P2, N=37, Active, not recruiting,  Sponsor: Duke University
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting

|||||||||| New P4 trial: The Study to Evaluate Efficacy and Safety of Newrabell® Tab.(Rabeprazole Sodium) 10mg b.i.d in Refractory GERD (clinicaltrials.gov) - May 20, 2013
P4, N=40, Recruiting, Sponsor: Chong Kun Dang Pharmaceutical

|||||||||| Trial completion: Predictors of the Ability to Protect the Airway in Long-term Ventilated Patients (clinicaltrials.gov) - May 20, 2013
P=N/A, N=30, Completed, Sponsor: Massachusetts General Hospital
Recruiting --> Active, not recruiting Recruiting --> Completed

||||||||||  pantoprazole / Generic mfg.
Enrollment change:  Intravenous (IV) Pantoprazole for Gastroesophageal Reflux Disease (GERD) in Neonates and Infants (clinicaltrials.gov) -  May 20, 2013
P1, N=24, Completed,  Sponsor: University of Louisville
Recruiting --> Completed N=36 --> 24

||||||||||  pantoprazole / Generic mfg.
Trial completion:  Intravenous (IV) Pantoprazole for Gastroesophageal Reflux Disease (GERD) in Neonates and Infants (clinicaltrials.gov) -  May 20, 2013
P1, N=24, Completed,  Sponsor: University of Louisville
N=36 --> 24 Recruiting --> Completed

|||||||||| Trial completion: Confocal Laser Microscopy in Non Erosive Reflux Disease (clinicaltrials.gov) - May 16, 2013
P=N/A, N=60, Completed, Sponsor: Mayo Clinic
Recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Leukine (sargramostim) / Partner Therap
Trial termination:  Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract (clinicaltrials.gov) -  May 14, 2013
P2, N=7, Terminated,  Sponsor: The University of Texas, Galveston
Active, not recruiting --> Completed Completed --> Terminated; Administratively Terminated

||||||||||  cisplatin / Generic mfg.
New P2 trial:  S1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical Study (clinicaltrials.gov) -  May 14, 2013
P2, N=48, Recruiting,  Sponsor: Fudan University

||||||||||  5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., cisplatin / Generic mfg.
Trial completion:  Radiation Therapy + Combination Chemotherapy as 1st-Line Therapy for Patients With Inoperable Esophageal Cancer (clinicaltrials.gov) -  May 14, 2013
P2/3, N=266, Completed,  Sponsor: UNICANCER
Completed --> Terminated; Administratively Terminated Recruiting --> Completed

||||||||||  esomeprazole / Generic mfg.
Trial initiation date:  Study to Investigate the Safety, Tolerability and Efficacy of YH4808 in Patients With Reflux Esophagitis (clinicaltrials.gov) -  May 12, 2013
P2, N=150, Active, not recruiting,  Sponsor: Yuhan Corporation
Recruiting --> Completed Initiation date: Sep 2012 --> Dec 2012

||||||||||  esomeprazole / Generic mfg.
Enrollment change:  Study to Investigate the Safety, Tolerability and Efficacy of YH4808 in Patients With Reflux Esophagitis (clinicaltrials.gov) -  May 12, 2013
P2, N=150, Active, not recruiting,  Sponsor: Yuhan Corporation
Initiation date: Sep 2012 --> Dec 2012 N=120 --> 150

||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
Trial termination, Metastases:  Preoperative Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma (clinicaltrials.gov) -  May 8, 2013
P=N/A, N=8, Terminated,  Sponsor: University of Colorado, Denver
N=120 --> 150 Recruiting --> Terminated; This study was terminated due slow accrual.

||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
Enrollment change, Metastases:  Preoperative Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma (clinicaltrials.gov) -  May 8, 2013
P=N/A, N=8, Terminated,  Sponsor: University of Colorado, Denver
Recruiting --> Terminated; This study was terminated due slow accrual. N=15 --> 8

|||||||||| Enrollment change: High Resolution Optical Imaging of Barrett's Esophagus Using Nvision Volumetric Laser Endomicroscopy (VLE) (clinicaltrials.gov) - May 2, 2013
P=N/A, N=120, Completed, Sponsor: NinePoint Medical
N=15 --> 8 N=100 --> 120

||||||||||  fluticasone / Generic mfg.
New P4 trial:  Dietetic Versus Topical Steroids for Pediatric Eosinophilic Esophagitis (clinicaltrials.gov) -  May 2, 2013
P4, N=60, Recruiting,  Sponsor: Azienda Policlinico Umberto I

|||||||||| Trial completion: Epidemiology of Barrett's Esophagus: A Population Based Study (clinicaltrials.gov) - May 2, 2013
P=N/A, N=534, Completed, Sponsor: Mayo Clinic
N=100 --> 120 Enrolling by invitation --> Completed

|||||||||| Trial completion, Stroma: CR20: Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus (clinicaltrials.gov) - May 2, 2013
P=N/A, N=48, Completed, Sponsor: Mayo Clinic
Enrolling by invitation --> Completed Enrolling by invitation --> Completed

|||||||||| Trial termination: Quantifying Effects of Treatment of Pediatric Dysphonia (clinicaltrials.gov) - Apr 30, 2013
P=N/A, N=31, Terminated, Sponsor: University of Wisconsin, Madison
Enrolling by invitation --> Completed Active, not recruiting --> Terminated; Terminated due to funding loss.

|||||||||| Enrollment change: Quantifying Effects of Treatment of Pediatric Dysphonia (clinicaltrials.gov) - Apr 30, 2013
P=N/A, N=31, Terminated, Sponsor: University of Wisconsin, Madison
Active, not recruiting --> Terminated; Terminated due to funding loss. N=50 --> 31

||||||||||  ONO-8539 / Ono Pharma
Enrollment open:  A Study of the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease (clinicaltrials.gov) -  Apr 30, 2013
P1, N=30, Recruiting,  Sponsor: Ono Pharmaceutical Co. Ltd
N=50 --> 31 Not yet recruiting --> Recruiting

||||||||||  lapatinib / Generic mfg., carboplatin / Generic mfg., paclitaxel / Generic mfg.
Enrollment change, Combination therapy, Metastases:  Lapatinib With Carboplatin and Paclitaxel in Esophagus and Gastroesophageal Junction (GEJ) (clinicaltrials.gov) -  Apr 29, 2013
P1/2, N=13, Active, not recruiting,  Sponsor: Case Comprehensive Cancer Center
Not yet recruiting --> Recruiting N=43 --> 13

||||||||||  lapatinib / Generic mfg., carboplatin / Generic mfg., paclitaxel / Generic mfg.
Enrollment closed, Combination therapy, Metastases:  Lapatinib With Carboplatin and Paclitaxel in Esophagus and Gastroesophageal Junction (GEJ) (clinicaltrials.gov) -  Apr 29, 2013
P1/2, N=13, Active, not recruiting,  Sponsor: Case Comprehensive Cancer Center
N=43 --> 13 Recruiting --> Active, not recruiting

|||||||||| Trial completion: Study of Photodynamic Therapy (PDT) Using HPPH in Barrett's Esophagus (clinicaltrials.gov) - Apr 29, 2013
P1/2, N=18, Completed, Sponsor: Roswell Park Cancer Institute
Recruiting --> Active, not recruiting Active, not recruiting --> Completed



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