Gastroparesis Registry - NCT00398801-27157 (Clinical Trial 155093)
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| City: |
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Winston-Salem |
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State:
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NC |
| Zip Code: |
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27157 |
| Conditions: |
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Gastroparesis |
| Purpose: |
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The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology,
natural history, clinical course, and other outcomes of gastroparesis.
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| Study summary: |
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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: |
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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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| Study is available at: |
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Wake Forest University Health Sciences
Winston-Salem, NC 27157
United States
Primary Contact:
Kenneth L Koch, MD
Email: kkoch@wfubmc.edu
Phone: 336-713-7333 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 15, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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