Infant, PrematurePhase 4NCT01281566
A Study of Cisapride in Premature Infants With Feeding Problems
A Phase 4 study testing Cisapride in people with Infant, Premature and Infant, Newborn, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate the effectiveness of Cisapride in improving feeding problems in premature newborn infants. Read more about this study
- Who is it for?
- Ages 36 to 99 weeks
- Conditions the study is for
- Infant, Premature, Infant, Newborn
- What is being tested?
- Cisapride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Jul 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 36 to 99 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Must be hospitalized and on continuous cardiac monitoring for the duration of the study
- Patient has demonstrated feeding intolerance as defined by the protocol
- Patient's parent or legal guardian must sign the informed consent form
Who cannot join
- Currently active significant cardiovascular disease, as determined by the neonatologist/physician, including congenital heart disease and heart block (patent ductus arteriosus without cardiac compromise at the time of randomization is acceptable)
About this study
Official title: Double-blind, Randomized, Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of R051619 (Cisapride Oral Suspension 0.2mg/kg q.i.d) for the Treatment of Feeding Intolerance in Premature Infants
The purpose of this study is to evaluate the effectiveness of Cisapride in improving feeding problems in premature newborn infants.
Read the detailed description
This is a double-blind study where the identity of the treatment assigned (Cisapride or placebo) will not be known to the patient's legal guardian or any study staff involved with the study. Patients will be randomized (assigned by chance) to receive either the drug Cisapride or a placebo (a placebo is identical in appearance to Cisapride but does not contain Cisapride or any active drug) to see if Cisapride is effective in improving feeding problems (referred to as feeding intolerance) in premature newborn infants who cannot tolerate oral feeding by mouth or through a tube going directly to the stomach or intestine. Patients will be given either cisapride at a dose of 0.2 mg/kg or placebo as a liquid suspension through a tube from the nose to the stomach (referred to as a nasogastric tube) 15 minutes before feeding once every 6 hours (or 4 times a day referred to as a q.i.d. schedule).
- Conditions
- Infant, Premature, Infant, Newborn
- Being tested
- Placebo, Cisapride
- Keywords
- Cisapride (Prepulsid), Feeding intolerance, Enteral feeding, Nasogastric tube, Neonate
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
liquid suspension identical in appearance to Cisapride 4 times a day (q.i.d.) for up to 42 days
CisaprideDrug
0.2 mg/kg liquid suspension 4 times a day (q.i.d.) for up to 42 days
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Cisapride 0.2 mg/kg liquid suspension 4 times a day (q.i.d.) for up to 42 days Receives: Drug: Cisapride |
| 002 | Placebo comparator | Placebo liquid suspension identical in appearance to Cisapride 4 times a day (q.i.d.) for up to 42 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from start of study medication to full enteral feeding
Measured: Up to 42 days
Secondary outcomes (1)
Number and type of adverse events
Measured: Up to 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startMar 2003
- Study completionJul 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 Infant, PrematureStudies 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
- 8 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
- NCT01281566
- Sponsor's protocol ID
- CR003955
- Other IDs
- CIS-INT-28
- Status last verified
- Jan 2011
- First submitted
- 20 Jan 2011
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of R051619 (Cisapride Oral Suspension 0.2mg/kg q.i.d) for the Treatment of Feeding Intolerance in Premature Infants
- ClinicalTrials.gov ID
- NCT01281566
- Acronym / sponsor ID
- CR003955
- Conditions
- Infant, Premature, Infant, Newborn
- Keywords
- Cisapride (Prepulsid), Feeding intolerance, Enteral feeding, Nasogastric tube, Neonate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor request
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Mar 2003
- Study completion
- Jul 2003 (actual)
- First posted
- 24 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 evaluate the effectiveness of Cisapride in improving feeding problems in premature newborn infants.
Detailed description
This is a double-blind study where the identity of the treatment assigned (Cisapride or placebo) will not be known to the patient's legal guardian or any study staff involved with the study. Patients will be randomized (assigned by chance) to receive either the drug Cisapride or a placebo (a placebo is identical in appearance to Cisapride but does not contain Cisapride or any active drug) to see if Cisapride is effective in improving feeding problems (referred to as feeding intolerance) in premature newborn infants who cannot tolerate oral feeding by mouth or through a tube going directly to the stomach or intestine. Patients will be given either cisapride at a dose of 0.2 mg/kg or placebo as a liquid suspension through a tube from the nose to the stomach (referred to as a nasogastric tube) 15 minutes before feeding once every 6 hours (or 4 times a day referred to as a q.i.d. schedule).
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 0.2 mg/kg liquid suspension 4 times a day (q.i.d.) for up to 42 days |
| 002 | Placebo comparator | Drug: PlaceboPlacebo liquid suspension identical in appearance to Cisapride 4 times a day (q.i.d.) for up to 42 days |
Who may qualify
- Ages
- 36 to 99 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Must be hospitalized and on continuous cardiac monitoring for the duration of the study
- Patient has demonstrated feeding intolerance as defined by the protocol
- Patient's parent or legal guardian must sign the informed consent form
Key exclusion criteria (1 listed)
- Currently active significant cardiovascular disease, as determined by the neonatologist/physician, including congenital heart disease and heart block (patent ductus arteriosus without cardiac compromise at the time of randomization is acceptable)
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 |
|---|---|---|
| Placeboliquid suspension identical in appearance to Cisapride 4 times a day (q.i.d.) for up to 42 days | Drug | 002 |
| Cisapride0.2 mg/kg liquid suspension 4 times a day (q.i.d.) for up to 42 days | Drug | 001 |
Primary outcome
Time from start of study medication to full enteral feeding
Time frame: Up to 42 days
1 secondary outcome
Number and type of adverse events
Time frame: Up to 42 days
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 24 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 Infant, Premature and Infant, Newborn, 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 3 inclusion and 1 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 24 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. Some participants in this study may receive a placebo. 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?
Time from start of study medication to full enteral feeding (time frame: Up to 42 days). 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 24 Jan 2011.