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| ID | Type | Description | Link |
|---|---|---|---|
| CIS-INT-25 |
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Sponsor request
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The purpose of this study is to assess the effectiveness of cisapride at improving symptoms associated with gastroparesis (a stomach disorder) in patients with diabetes mellitus.
This is a double-blind (neither the physician nor the patient will know the name of assigned treatment) study to determine the effectiveness of cisapride tablets compared to placebo tablets (a tablet identical in appearance to cisapride but does not contain active drug) at improving symptoms associated with diabetic gastroparesis when administered orally (by mouth) to patients with insulin dependent or non-insulin dependent diabetes mellitus. Gastroparesis is a disorder also called delayed gastric emptying, in which the stomach takes too long to empty food into the small intestine for digestion. Symptoms of gastroparesis may include vomiting, nausea, early feeling of fullness after only a few bites of food, weight loss due to poor absorption of nutrients or low calorie intake, abdominal bloating, poor glycemic (blood sugar) control, lack of appetite, and pain in the stomach area. Patients will take study drug (one 10-mg tablet of cisapride, or one tablet of placebo), orally, 4 times a day, for a period of 8 weeks. Study drug will be taken approximately 15 minutes before each meal and, with a beverage, before going to bed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | Cisapride One 10-mg tablet taken orally 4 times a day for up to 8 weeks. |
|
| 002 | Experimental | Placebo One tablet taken orally 4 times a day for up to 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisapride | Drug | One 10-mg tablet taken orally 4 times a day for up to 8 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in Gastroparesis Cardinal Symptoms Index (GCSI) score | At baseline (Visit 2) and weekly during the treatment phase of the trial for up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The number of adverse events reported | For the duration of the study (up to 8 weeks) | |
| The type of adverse events reported | For the duration of the study (up to 8 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
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| Placebo |
| Drug |
One tablet taken orally 4 times a day for up to 8 weeks. |
|
| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D020117 | Cisapride |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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