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

This study has been terminated.
(Sponsor request)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01286090
First Posted: January 31, 2011
Last Update Posted: January 31, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  Purpose
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.

Condition Intervention Phase
Gastroparesis Diabetes Mellitus Drug: Cisapride Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of R051619 (Cisapride 10 mg Q.I.D.) Versus Placebo for the Improvement of Symptoms Associated With Exacerbations of Gastroparesis, After Failure of Other Treatments, in Patients With Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • The change from baseline in Gastroparesis Cardinal Symptoms Index (GCSI) score [ Time Frame: At baseline (Visit 2) and weekly during the treatment phase of the trial for up to 8 weeks ]

Secondary Outcome Measures:
  • The number of adverse events reported [ Time Frame: For the duration of the study (up to 8 weeks) ]
  • The type of adverse events reported [ Time Frame: For the duration of the study (up to 8 weeks) ]

Enrollment: 4
Study Start Date: July 2003
Study Completion Date: October 2003
Arms Assigned Interventions
Experimental: 001
Cisapride One 10-mg tablet taken orally 4 times a day for up to 8 weeks.
Drug: Cisapride
One 10-mg tablet taken orally 4 times a day for up to 8 weeks.
Experimental: 002
Placebo One tablet taken orally 4 times a day for up to 8 weeks.
Drug: Placebo
One tablet taken orally 4 times a day for up to 8 weeks.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01286090


Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Responsible Party: Portfolio/CDT Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01286090     History of Changes
Other Study ID Numbers: CR003946
CIS-INT-25
First Submitted: January 13, 2011
First Posted: January 31, 2011
Last Update Posted: January 31, 2011
Last Verified: January 2011

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Cisapride (PREPULSID)
Placebo
Diabetes mellitus
Diabetic gastroparesis

Additional relevant MeSH terms:
Diabetes Mellitus
Gastroparesis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Cisapride
Anti-Ulcer Agents
Gastrointestinal Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs