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A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Single-dose, Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-1701 in Patients With Achalasia
Rochester, Minn.
The objectives of this study are as follows: In patients with primary Type I or II Achalasia, following a single 5-mg dose of IW-1701, - To assess the safety and tolerability - To determine the effects on measures of esophageal function by high-resolution impedance manometry (HRIM) - To determine the pharmacokinetic (PK) parameters, Cmax, Tmax, and AUClast
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A Phase 3, Multicenter, Double-blind Extension Study to Evaluate Maintenance of Efficacy of Oral Budesonide Suspension (OBS) and Long-term Treatment Effect of OBS in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis (EoE) (ORBIT2)
Rochester, Minn.
This is a multicenter, double- blind extension study of Oral Budesonide Suspension (OBS) in adults and adolescents (11 to 55 years of age, inclusive) with Eosinophilic Esophagitis (EoE) who have completed participation in the SHP621-301 induction study (NCT02605837). The primary objective is to evaluate the maintenance of efficacy of OBS over 36 weeks. Maintenance of efficacy will be measured by the peak eosinophilic count and Dysphagia Symptom Questionnaire (DSQ) score.
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A Phase 3, Multicenter, Open-label Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Subjects With Eosinophilic Esophagitis (EoE)
Rochester, Minn.
This is a continuation study of Budesonide Oral Suspension (BOS) in adults and adolescents with Eosinophilic Esophagitis (EoE) who have completed participation in the SHP621-302 extension study. The purpose of this study is to see if BOS is safe and well tolerated over the long-term in adolescents and adults with EoE.
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Achalasia Long Term Follow up
Rochester, Minn.
The purpose of this study is to evaluate the long-term (30 years) clinical effectiveness of endoscopic and surgical interventions for achalasia.
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Characterize Gut Microbial Population in Patients with Eosinophilic Esophagitis
Rochester, Minn.
The purpose of this study is to collect stool samples and determine the intestine microbe environment in patients who have active or treated inactive eosinophilic esophagitis.
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CYP2C19 Genotype as a Predictor of Gastric Acid Suppression and Healing of Erosive Esophagitis
Rochester, Minn.
If CYP2C19 genotype can predict the efficacy of healing erosive esophagitis and gastric acid secretion in patients taking once a day omeprazole.
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EoE RNA Transcriptome Analysis in Patients with Eosinophilic Esophagitis.
Rochester, Minn.
The purpose of this study is to perform RNA (genetic) sequencing on biopsies taken from the esophagus of adult patients who have active eosinophilic esophagitis, and look for potential therapeutic targets.
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Esophageal Absorption in Eosinophilic Esophagitis
Rochester, Minn.
To determine how the esophagus in active and inactive stages of eosinophilic esophagitis transmit fluids.
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Is EPO Staining on Esophageal Sponge Samples a Simple Reliable Method of Accessing Esophageal Eosinophilia?
Rochester, Minn.
Are we able to use the EPO staining technique using the sponge ?
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Measurement of the Distal 5 cm of the Esophagus in Patients With Non-Erosive Reflux Disease and Controls (Impedance)
Rochester, Minn.
This study is being done to determine if people with and without GERD or trouble swallowing have increased esophageal mucosa impedance (food getting into the esophageal tissue).
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Mucosal Impedance in Eosinophilic Esophagitis and the Effect of Treatment
Rochester, Minn.
Do patients with eosinophilic esophagitis have baseline increased esophageal mucosal impedance? And will treatment that reverses esophageal eosinophilia in patients, correct abnormalities in mucosal impedance?
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Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) with Eosinophilic Esophagitis: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study
Rochester, Minn.
A study of the effectiveness of oral Budesonide suspension in adolescents and adults with eosinophilic esophagitis measuring the histologic response and determining if any decrease in difficult swallowing is achieved.
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Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11-40 Years of Age) with Eosinophilic Esophagitis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study with an Open Label Extension
Rochester, Minn.
This is a clinical trial to test an experimental drug for the treatment of Eosinophilic Esophagitis (EoE)
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Peroral Endoscopic Myotomy (POEM) for Treatment of Achalasia Combined with Laparoscopic Supplemental Myotomy and Antireflux Fundoplication
Rochester, Minn.
Based on the work of the Doctors at the Mayo Clinic Rochester, a new technique for a less invasive treatment for Achalasia has been developed.
The purpose of this study is to decide the role this less invasive treatment (Peroral Endoscopic Myotomy) has in the treatment of patient's with achalasia.
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Smoking and Esophageal Permeability Protocol
Rochester, Minn.
This study is being done to determine the effects smoking has on the esophagus (swallowing tube).
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The Effect of Sucralfate Slurry on Dilated Intercellular Spaces, Tight Junctions, Mucosal Impedance and Mucosal Activity in Patients with Eosinophilic Esophagitis
Rochester, Minn.
Could Sucralfate be a non-steriodal treatment option for patients with Eosinophilic esophagitis?
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