Gastroesophageal Reflux Disease

CLINICAL_TRIALS trial_result · 2009-08-06

Clinical Trial Update: National Survey on Gastroesophageal Reflux Disease (GERD) Patients

A completed AstraZeneca-sponsored clinical trial survey evaluating patients with gastroesophageal reflux disease (GERD).

CLINICAL_TRIALS withdrawal · 2009-08-03

Clinical Trial Update: vMII for Measurement of Oesophageal Bolus Transport and Reflux [NA]

The clinical trial NCT00604942 evaluating vMII for measuring oesophageal bolus transport and reflux was terminated.

FDA approval · 2009-07-31

FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

FDA approved a supplemental application for PREVACID SOLUTAB (lansoprazole) to add the Solutab dosage form to the approved product line. The…

CLINICAL_TRIALS research · 2009-07-17

Clinical Trial Update: Epidemiological Study to Assess the Symptoms and Patterns of Diagnosis and Treatment of GERD

A completed epidemiological study sponsored by AstraZeneca evaluating the symptoms, patterns of diagnosis, and treatment of gastroesophageal…

CLINICAL_TRIALS trial_result · 2009-07-13

Clinical Trial Update: An Evaluation of the Medtronic Gatekeeper System in the Treatment of SUBJECTS With Gastroesophageal Reflux Disease (GERD) [NA]

A clinical trial evaluating the Medtronic Gatekeeper System for treating gastroesophageal reflux disease has been terminated.

FDA approval · 2009-06-30

FDA Approved: METOCLOPRAMIDE HYDROCHLORIDE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC.)

FDA approved a supplemental application for metoclopramide hydrochloride (generic), filed by Chartwell Governmental & Specialty RX, LLC., as…

FDA approval · 2009-06-30

FDA Approved: REGLAN — Supplemental Application (ANI Pharmaceuticals, Inc.)

The FDA approved a supplemental application for Reglan (metoclopramide hydrochloride) submitted by ANI Pharmaceuticals, Inc. for NDA 017854.

FDA approval · 2009-06-30

FDA Approved: METOCLOPRAMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

The FDA approved ANI Pharmaceuticals' supplemental application for metoclopramide.

FDA approval · 2009-06-18

FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

The FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP to update the la…

CLINICAL_TRIALS withdrawal · 2009-06-08

Clinical Trial Update: The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease [Phase 3]

A Phase 3 clinical trial evaluating melatonin for gastroesophageal reflux disease has been withdrawn.

FDA label_change · 2009-05-28

FDA Approved: RANITIDINE — Supplemental Application (Pharmaceutical Associates, Inc.)

The FDA approved a supplemental application for ranitidine from Pharmaceutical Associates, Inc., indicating a labeling or related change to …

CLINICAL_TRIALS trial_result · 2009-05-13

Clinical Trial Update: Role of Mosapride in Patients With Gastroesophageal Reflux Disease [Phase 4]

A Phase 4 trial evaluating mosapride for gastroesophageal reflux disease has completed.

CLINICAL_TRIALS trial_result · 2009-05-08

Clinical Trial Update: Rabeprazole in Subjects With Gastroesophageal Reflux Disease (GERD) [Phase 2]

Phase 2 trial evaluating rabeprazole in subjects with gastroesophageal reflux disease has completed. The study was conducted under sponsorsh…

CLINICAL_TRIALS trial_result · 2009-04-22

Clinical Trial Update: Diagnostic Efficacy of Narrow Band Imaging in Patients With Gastroesophageal Reflux Disease

The document reports the completion of a clinical trial evaluating the diagnostic efficacy of narrow-band imaging for diagnosing gastroesoph…

CLINICAL_TRIALS trial_result · 2009-04-10

Clinical Trial Update: Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation [Phase 2]

A Phase 2 pharmacokinetic study of an enteral omeprazole suspension in patients with cerebral palsy and mental retardation evaluating the dr…

FDA approval · 2009-04-06

FDA Approved: RANITIDINE — Supplemental Application (Dr. Reddy's Laboratories Limited)

FDA approved a supplemental application for ranitidine submitted by Dr. Reddy's Laboratories Limited.

FDA approval · 2009-04-02

FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole), enabling continued marketing of the product unde…

CLINICAL_TRIALS trial_result · 2009-03-31

Clinical Trial Update: Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD) [Phase 4]

This update notes the completion of a Phase 4 clinical trial evaluating Nissen fundoplication and gastroplasty for gastroesophageal reflux d…

CLINICAL_TRIALS trial_result · 2009-03-26

Clinical Trial Update: NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis [Phase 4]

Phase 4 trial update completed evaluating Nexium (esomeprazole) for moderate to severe erosive esophagitis and related reflux conditions.

CLINICAL_TRIALS trial_result · 2009-03-26

Clinical Trial Update: HEARD (Long Term) Study - Histology of the Esophagus in Acid-Related Disease [Phase 3]

Phase 3 HEARD long-term study evaluating histology of the esophagus in acid-related disease has completed, sponsored by AstraZeneca.