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An Efficacy and Safety Study of Cisapride for Improving Symptoms Associated With Gastroparesis in Patients With Diabetes Mellitus

NCT ID: NCT01286090

Last Updated: 2011-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2003-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastroparesis Diabetes Mellitus

Keywords

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Cisapride (PREPULSID) Placebo Diabetes mellitus Diabetic gastroparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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001

Cisapride One 10-mg tablet taken orally 4 times a day for up to 8 weeks.

Group Type EXPERIMENTAL

Cisapride

Intervention Type DRUG

One 10-mg tablet taken orally 4 times a day for up to 8 weeks.

002

Placebo One tablet taken orally 4 times a day for up to 8 weeks.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

One tablet taken orally 4 times a day for up to 8 weeks.

Interventions

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Cisapride

One 10-mg tablet taken orally 4 times a day for up to 8 weeks.

Intervention Type DRUG

Placebo

One tablet taken orally 4 times a day for up to 8 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with insulin dependent or non-insulin dependent diabetes mellitus
* Experienced inadequate responses to, or have been intolerant of, treatment with at least one previous drug therapy for gastroparesis
* Have exacerbation of gastroparesis symptoms requiring medical attention
* Demonstrate delayed gastric emptying as assessed by a \[1-13C\]-Sodium Acetate Breath Test within 14 days before randomization

Exclusion Criteria

* Received prior treatment with cisapride
* Have a glycosylated hemoglobin (HbA1c) \>10% at screening, as determined by clinical laboratory testing
* Have any upper gastrointestinal (GI) pathology other than diabetic gastroparesis that would require therapy other than that provided in this trial
* Have any organic/neurological disease that is suspected to be causing gastroparesis, other than diabetes
* Currently vomiting, or receiving therapy for a severe exacerbation of gastroparesis, that would prevent the patient from receiving oral therapy or a diet
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role lead

Responsible Party

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Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Principal Investigators

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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Other Identifiers

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CIS-INT-25

Identifier Type: -

Identifier Source: secondary_id

CR003946

Identifier Type: -

Identifier Source: org_study_id