Clinical Trials for Gastroparesis

Clinical trials are research studies conducted in an effort to improve overall patient health and care. Each trial involves running supervised tests to determine the effectiveness and safety of new drugs, procedures and/or devices with the aim of answering scientific questions about a disease or condition. Risks and side-effects are also evaluated during these trials with results ranging from being unpleasant, with side effects such as headaches, to more serious or even life-threatening risks. A clinical trial may be separated into phases, or steps, with each step designed to answer a separate research question. This maybe reflected in the trial name.

A brief description of each phase:

• Phase I: Usually designed to evaluate safety, determine a safe dosage range, and identify side effects on a small group of patients.
• Phase II: If Phase I is successful, the trial is then repeated with a larger group to further evaluate its effect and safety.
• Phase III: Trials are conducted on an ever larger group and are compared with the best current treatment while gathering more information on effect and safety.
• Phase IV: These studies monitor long-term side effects after the treatment has been marketed.

Clinical Trials data for Gastroparesis is grouped into the following categories:-

• View by trial name
• View by drugs used in Gastroparesis clinical trials

Clinical Trials by trial name

The format for each of the following is:

• The name of the trial,
• followed by whether the trial is recruiting patients,
  - The trial may not have started and not yet recruiting, or the trial may have started and do not need any more recruitements, or the trial may be completed.
  - Note**: Please follow the link to determine the current trial status.
• followed by a list of drug/s, if any, used in the trial

ClinicalTrials.gov has listed the following trials for Gastroparesis:

• A Comparison of SmartPill Capsule With Scintigraphy for Determining Gastric Residence Time - This study is currently recruiting patients (Current: 23 Nov 2006)
• Effect of Electroacupuncture in Diabetic Patients With Gastroparesis - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Placebo Controlled Trial of Botulinum Toxin for Gastroparesis - This study is currently recruiting patients (Current: 23 Nov 2006) - Botulinum toxin type A
• Safety and Effectiveness of an Investigational Agent (GM-611) in Patients With Diabetic Gastroparesis - This study has been completed (Current: 23 Nov 2006) - GM-611
• A Study of IC351 (Tadalafil) for the Treatment of Diabetic Patients With Symptoms of Dyspepsia (Upset Stomach) and Gastroparesis (Delayed Gastric Emptying). - This study has been completed (Current: 23 Nov 2006) - IC351,tadalafil
• Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis) - This study is currently recruiting patients (Current: 23 Nov 2006)
• Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia - This study has been completed (Current: 23 Nov 2006) - Itopride Hydrochloride (prokinetic)
• Gastroparesis Registry - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis - This study is not yet open for patient recruitment (Current: 23 Nov 2006) - Tegaserod
• A Randomized, Open-Label, Two-Way Crossover Trial to Determine the Pharmacokinetics of Metoclopramide When Administered as the Orally Disintegrating Tablet Compared to Reglan Tablets in Subjects With Diabetic Gastroparesis - This study is no longer recruiting patients (Current: 23 Nov 2006) - Reglan ODT

Drugs used in Clinical Trials for Gastroparesis

The format for each of the following is:

• The drug,
• followed by the name of the trial,
• followed by whether the trial is recruiting patients,
  - The trial may not have started and not yet recruiting, or the trial may have started and do not need any more recruitements, or the trial may be completed.
  - Note**: Please follow the link to determine the current trial status.

ClinicalTrials.gov has listed the following drugs in trials for Gastroparesis:

• Botulinum toxin type A - Placebo Controlled Trial of Botulinum Toxin for Gastroparesis - This study is currently recruiting patients (Current: 23 Nov 2006)
• GM-611 - Safety and Effectiveness of an Investigational Agent (GM-611) in Patients With Diabetic Gastroparesis - This study has been completed (Current: 23 Nov 2006)
• IC351 - A Study of IC351 (Tadalafil) for the Treatment of Diabetic Patients With Symptoms of Dyspepsia (Upset Stomach) and Gastroparesis (Delayed Gastric Emptying). - This study has been completed (Current: 23 Nov 2006)
• Itopride Hydrochloride (prokinetic) - Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia - This study has been completed (Current: 23 Nov 2006)
• Reglan ODT - A Randomized, Open-Label, Two-Way Crossover Trial to Determine the Pharmacokinetics of Metoclopramide When Administered as the Orally Disintegrating Tablet Compared to Reglan Tablets in Subjects With Diabetic Gastroparesis - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Tadalafil - A Study of IC351 (Tadalafil) for the Treatment of Diabetic Patients With Symptoms of Dyspepsia (Upset Stomach) and Gastroparesis (Delayed Gastric Emptying). - This study has been completed (Current: 23 Nov 2006)
• Tegaserod - Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis - This study is not yet open for patient recruitment (Current: 23 Nov 2006)

The trial data on this page has been sourced from

• The U.S. National Library of Medicine (NLM) together with ClinicalTrials.gov

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