An Efficacy and Safety Study of Cisapride in Patients With Chronic Gastroparesis After Failure of Other Treatment Options

NCT01281540 | Terminated Phase 4

• 2 other identifiers: CR003949CIS-INT-26
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the effectiveness of cisapride in patients with a primary diagnosis of chronic gastroparesis (a stomach disorder) of unknown cause.

Conditions

Gastroparesis

Keywords

Cisapride ( PREPULSID ); Placebo; Idiopathic; Stomach Diseases; Stomach

Outcome Measures

Primary Outcomes (1)

• The average change from baseline in Gastroparesis Cardinal Symptoms Index (GCSI) score

  At baseline (Week 0) up to 8 weeks

Secondary Outcomes (1)

• The number and type of adverse events reported

  From time of first dose to the last dose (up to 8 weeks)

Study Arms (2)

001

EXPERIMENTAL

Cisapride one 10 mg tablet 4 times a day for 8 weeks

Drug: Cisapride

002

PLACEBO COMPARATOR

Placebo one placebo tablet 4 times a day for 8 weeks

Drug: Placebo

Interventions

Cisapride DRUG

one 10 mg tablet 4 times a day for 8 weeks

001

Placebo DRUG

one placebo tablet 4 times a day for 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 nondiabetic idiopathic gastroparesis and having symptoms for at least 12 weeks in the preceeding 12 months
• Experienced inadequate response, or intolerance to therapy to date
• 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 gycosylated hemoglobin (HbA1c) \>7% and bloodglucose of 126 mg/dL (7.0 mmol/L) or greater at screening, as determined by clinical laboratory testing
• Have any upper gastrointestinal (GI) pathology other than idiopathic gastroparesis that would require therapy other than that provided in this trial
• Have any organic/neurological disease that is suspected to be causing gastroparesis
• 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; Stomach Diseases

Interventions

Cisapride

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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 20, 2011
• First Posted: January 24, 2011
• Study Start: May 1, 2003
• Study Completion: November 1, 2003
• Last Updated: January 24, 2011

Record last verified: 2011-01