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
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ClinicalTrials.gov Identifier: NCT00139893 |
Recruitment Status :
Completed
First Posted : August 31, 2005
Last Update Posted : March 26, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Gastroparesis | Drug: Reglan ODT | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | June 2005 |
Actual Primary Completion Date : | October 2005 |


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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects must be 18 or older, have Type 1 or 2 diabetes with documented gastroparesis
Exclusion Criteria:
- Serum glucose >300 mg/dL, HbA1C >10%, and concurrent illness interfering with gastrointestinal motility

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139893
United States, Wisconsin | |
Schwarz | |
Milwaukee, Wisconsin, United States |
Study Director: | Patricia Witt | UCB Pharma |
Responsible Party: | UCB Pharma |
ClinicalTrials.gov Identifier: | NCT00139893 |
Other Study ID Numbers: |
SP850 |
First Posted: | August 31, 2005 Key Record Dates |
Last Update Posted: | March 26, 2013 |
Last Verified: | May 2008 |
Gastroparesis Stomach Diseases Gastrointestinal Diseases Digestive System Diseases Paralysis Neurologic Manifestations Metoclopramide Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Dopamine D2 Receptor Antagonists Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |