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

NCT01286090 | Terminated Phase 4

• 2 other identifiers: CR003946CIS-INT-25
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gastroparesis; Diabetes Mellitus

Keywords

Cisapride (PREPULSID); Placebo; Diabetes mellitus; Diabetic gastroparesis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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)

Study Arms (2)

001

EXPERIMENTAL

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

Drug: Cisapride

002

EXPERIMENTAL

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

Drug: Placebo

Interventions

Cisapride DRUG

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

001

Placebo DRUG

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

002

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

MeSH Terms

Conditions

Gastroparesis; Diabetes Mellitus

Interventions

Cisapride

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 31, 2011
• Study Start: July 1, 2003
• Study Completion: October 1, 2003
• Last Updated: January 31, 2011

Record last verified: 2011-01