GastroparesisPhase 4NCT01286090
An Efficacy and Safety Study of Cisapride for Improving Symptoms Associated With Gastroparesis in Patients With Diabetes Mellitus
A Phase 4 study testing Cisapride in people with Gastroparesis and Diabetes Mellitus, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroparesis, Diabetes Mellitus
- What is being tested?
- Cisapride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Oct 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Gastroparesis, Diabetes Mellitus
- Being tested
- Cisapride, Placebo
- Keywords
- Cisapride (PREPULSID), Placebo, Diabetes mellitus, Diabetic gastroparesis
- Medical subject headings
- Gastroparesis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisaprideDrug
One 10-mg tablet taken orally 4 times a day for up to 8 weeks.
PlaceboDrug
One tablet taken orally 4 times a day for up to 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Cisapride One 10-mg tablet taken orally 4 times a day for up to 8 weeks. Receives: Drug: Cisapride |
| 002 | Experimental | Placebo One tablet taken orally 4 times a day for up to 8 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in Gastroparesis Cardinal Symptoms Index (GCSI) score
Measured: 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
Measured: For the duration of the study (up to 8 weeks)
The type of adverse events reported
Measured: For the duration of the study (up to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startJul 2003
- Study completionOct 2003
Why it stopped: Sponsor request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286090
- Sponsor's protocol ID
- CR003946
- Other IDs
- CIS-INT-25
- Status last verified
- Jan 2011
- First submitted
- 13 Jan 2011
- Last updated
- 31 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01286090
- Acronym / sponsor ID
- CR003946
- Conditions
- Gastroparesis, Diabetes Mellitus
- Keywords
- Cisapride (PREPULSID), Placebo, Diabetes mellitus, Diabetic gastroparesis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor request
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jul 2003
- Study completion
- Oct 2003 (actual)
- First posted
- 31 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: CisaprideCisapride One 10-mg tablet taken orally 4 times a day for up to 8 weeks. |
| 002 | Experimental | Drug: PlaceboPlacebo One tablet taken orally 4 times a day for up to 8 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CisaprideOne 10-mg tablet taken orally 4 times a day for up to 8 weeks. | Drug | 001 |
| PlaceboOne tablet taken orally 4 times a day for up to 8 weeks. | Drug | 002 |
Primary outcome
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
2 secondary outcomes
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)
Results and safety
The study was stopped early (reason given: Sponsor request). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cisapride in people with Gastroparesis and Diabetes Mellitus, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor request). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2011.