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Gastroparesis Registry - NCT00398801-79905(Clinical Trial 466376)



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City:  El Paso
State:  
TX
Zip Code: 79905
Conditions: Gastroparesis
Purpose: The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis.
Study summary: The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis. The Gastroparesis Registry will also provide a resource to inform the development of clinical trials and ancillary studies of the epidemiology, etiology, pathophysiology, and impact of gastroparesis.
Criteria: Inclusion Criteria: - Symptoms of gastroparesis of at least 12 weeks duration (do not have to be contiguous) with varying degrees of nausea, vomiting, abdominal pain, early satiety, post-prandial fullness, - Completion of a 4-hour scintigraphic low fat Egg Beaters gastric emptying study - Patients with either or both abnormal 2 hour (>60% retention) and 4 hour (>10% retention) gastric emptying will be enrolled and classified as definite gastroparesis (Gp) - Patients with normal gastric emptying, but with symptoms of gastroparesis may be enrolled and classified as possible gastroparesis or gastroparesis-like with normal gastric emptying (GLNGE) - Age at least 18 years at initial screening visit - Ability and willingness to participate in follow-up Exclusion Criteria: - Inability to comply with or complete the gastric emptying scintigraphy - Presence of other conditions that could explain the patient's symptoms: - Pyloric or intestinal obstruction - Active inflammatory bowel disease - Eosinophilic gastroenteritis - Neurological conditions such as increased intracranial pressure, space occupying or inflammatory/infectious lesions - Acute liver failure - Advanced liver disease (Child's B or C) - Acute renal failure - Untreated chronic renal failure (serum creatinine >3 mg/dL) - Total or subtotal gastric resection (patients with prior fundoplication or postvagotomy gastroparesis after pyloroplasty or antrectomy with Billroth I, Billroth II, or Roux-en-Y gastrojejunostomy will be eligible for enrollment) - Any other plausible structural or metabolic cause - Any other condition, which in the opinion of the investigator would interfere with study requirements - Inability to obtain informed consent
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Data Source: ClinicalTrials.gov
Date Processed: July 21, 2010
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