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Gastroparesis clinical trials

View clinical trials related to Gastroparesis.

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NCT ID: NCT00556166 Terminated - Gastroparesis Clinical Trials

Enterra Therapy Gastric Stimulation System

Enterra
Start date: October 2004
Phase: Phase 4
Study type: Interventional

Enterra Therapy Gastric Simulation System (Enterra Therapy) is indicated for the treatment of patients with long term, uncontrolled (not helped by medication) nausea and vomiting from gastroparesis of diabetic or idiopathic origin. In March 2000, the Food and Drug Administration (FDA) gave approval of a humanitarian Device Exemption (HDE) of a Humanitarian Use Device (HUD) for Enterra Therapy Gastric electrical (GES) Simulation System. Although, there is evidence that suggests the use of Enterra Therapy System probably helps patients, symptoms, the FDA's HDE approval indicates that the helpfulness of this therapy has not been proven. Physicians at Columbia University Medical Center hope to prove the helpfulness of this device.

NCT ID: NCT00552422 Terminated - Clinical trials for Gastroesophageal Reflux

Domperidone for Gastroparesis in Solid Organ Transplantation

Start date: March 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the clinical response to domperidone in solid organ transplant recipients with gastroparesis.

NCT ID: NCT00501657 Completed - Diabetes Mellitus Clinical Trials

Effects of Sitagliptin on Gastric Emptying in Healthy Subjects

Start date: July 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the effects of the drug, sitagliptin, on the rate at which the stomach empties, and the release of gut hormones and blood glucose concentrations, after a mashed potato meal in healthy subjects. Sitagliptin has been shown to reduce the blood glucose (sugar) response to a meal and this may potentially be due to slowing of stomach emptying. This is particularly relevant to people who have diabetes, in whom normalization of elevated blood glucose levels is important to maintain health.

NCT ID: NCT00492622 Completed - Clinical trials for Gastroesophageal Reflux Disease

Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis

Start date: June 2007
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the blood drug levels of two prescribed medications, immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to determine which drug is better absorbed in patients with a slow stomach emptying (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a protective coating. Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis.

NCT ID: NCT00470795 Suspended - Clinical trials for Diabetic Gastroparesis

Acupuncture for Diabetic Gastroparesis

Start date: June 2009
Phase: Phase 3
Study type: Interventional

Gastroparesis is a common complication of prolonged diabetes mellitus, both with Type 1 and Type 2 forms. Treatment of diabetic gastroparesis ranges from changing dietary habits to medications and invasive procedures, all of which offer only partial and transient relief, with some options having potentially harmful effects. Acupuncture is an ancient treatment which has been found to be beneficial for many ailments, including those involving the gastrointestinal tract. We propose to evaluate whether acupuncture is an effective and safe treatment for diabetic gastroparesis using a randomized, double-blind, placebo/sham-controlled crossover trial. Because symptoms of gastroparesis do not correlate well with objective tests of gastric emptying (i.e., scintigraphy or 13C breath tests), our primary outcome value will be the Gastroparesis Cardinal Symptom Index (GCSI), a reliable and validated instrument for quantifying symptoms in these patients. As a secondary outcome we will measure gastric emptying using a C13-acetate breath test, as well as the SF-12 Short Form Health Survey. Blinding of the participants will be evaluated using a Validation of Blinding Questionnaire at the end of the treatment period. Diabetic patients suffering from moderate gastroparesis (total GCSI score > 2.50) who fulfill the inclusion criteria (and none of the exclusion criteria) will be eligible to participate in the study. On induction, participants will fill out the GCSI questionnaire and SF-36 survey, and will undergo a C13-acetate breath test. They will then be randomly assigned to either true acupuncture treatment or placebo/sham acupuncture treatment. Each participant will undergo 8 treatments twice-weekly, for a period of 4 weeks. At the end of the eighth treatment session, each participant will again fill out a GCSI questionnaire and SF-12 form, as well as repeating the C13-acetate breath. Following a 4-week washout period, patients will be crossed over to either placebo/sham or true acupuncture treatment, again 8 twice-weekly treatments, for a period of 4 weeks. At the end of the second treatment regimen all participants will again fill out a GCSI questionnaire and SF-12 form, and undergo a C13-acetate breath test. At the end of the second treatment regimen participants will again fill out a Validation of Blinding Questionnaire.

NCT ID: NCT00432835 Completed - Gastroparesis Clinical Trials

Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis

Start date: August 2005
Phase: Phase 3
Study type: Interventional

The purpose of this research is to determine if temporary gastric electrical stimulation will help improve symptoms of gastroparesis (abnormal stomach emptying). We hypothesize that when the device is ON, Gastrointestinal symptoms will decrease by at least 50% from baseline.

NCT ID: NCT00398801 Completed - Gastroparesis Clinical Trials

Gastroparesis Registry

GpR
Start date: December 2006
Phase:
Study type: Observational

The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis.

NCT ID: NCT00390975 Terminated - Diabetes Clinical Trials

Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis

Start date: January 2007
Phase: Phase 4
Study type: Interventional

This study will assess gastric emptying in patients with symptoms of diabetic gastroparesis treated with tegaserod over 2 weeks.

NCT ID: NCT00372970 Completed - Gastroparesis Clinical Trials

Placebo Controlled Trial of Botulinum Toxin for Gastroparesis

Start date: July 2003
Phase: N/A
Study type: Interventional

It is hypothesized that in some patients with gastroparesis increased pyloric tone may be a contributing feature. Botox relaxes the pylorus so that food can empty the stomach more rapidly. Lesser quality studies have shown that this treatment works in about 40% of patients, and relieves symptoms for up to 3 months. This study compares this treatment to placebo (saline) injection. After a 1 month period patients may elect to receive open label botox who have not received relief from their first injection. Patients symptoms and gastric emptying are followed for 1 year.

NCT ID: NCT00370084 Completed - Gastroparesis Clinical Trials

Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia

Start date: March 2005
Phase: Phase 1/Phase 2
Study type: Interventional

Itopride is a new compound that is already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms associated with gastroparesis. Due to inadequate gastric emptying, these patients often have symptoms of bloating, nausea and vomiting following ingestion of a meal. The goal of this study is to evaluate the effects of Itopride on gastric motor function and glycemia in patients with diabetes.