Gastroesophageal RefluxPhase 4NCT01281553
A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease
A Phase 4 study testing Cisapride in people with Gastroesophageal Reflux, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to compare the efficacy and tolerability of cisapride with placebo in infants and children with gastro-oesophageal reflux disease (GORD). Read more about this study
- Who is it for?
- Ages 1 month to 18 months
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Cisapride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Sep 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 1 month to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of GORD based on protocol-specified characteristics
- Failed the 1st of 5 stepwise treatments for GORD recommended by the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)
- Caregiver able to complete the I-GERQ-R questionnaire
Who cannot join
- Protocol-specified respiratory conditions requiring previous or current treatment with oral or intravenous corticosteroids (prior and concurrent use of inhaled corticosteroids is acceptable)
- Cause of vomiting/regurgitation other than GORD
- Prior history of cisapride intake
About this study
Official title: Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of R051619 (Cisapride Oral Suspension 0.2 mg/kg q.i.d.) for the Treatment of Symptomatic Gastro-Oesophageal Reflux Disease (GORD) in Infants and Children
The purpose of this study is to compare the efficacy and tolerability of cisapride with placebo in infants and children with gastro-oesophageal reflux disease (GORD).
Read the detailed description
This is a double-blind (neither patient nor study staff will know the identity of the assigned treatment) study evaluate the effectiveness and safety of cisapride in patients with gastro-oesophageal reflux disease (GORD) (also referred to as gastroesophageal reflux disease [GERD[) compared to a placebo (a identical in appearance to cisapride but does not contain active drug). Patients will receive placebo or cisapride suspension at 0.2 mg/kg (volumn determined by patient weight) four times per day (q.i.d.) (15 minutes before feeding 3 times a day and at bedtime) orally (by mouth) for 8 weeks.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Placebo, Cisapride
- Keywords
- Cisapride (PREPULSID), Placebo, Gastroesophageal Reflux Disease (GERD), Gastro-oesophageal Reflux Disease (GORD)
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Suspension identical in appearance to cisapride q.i.d. for 8 weeks.
CisaprideDrug
0.2 mg/kg suspension q.i.d.for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Cisapride 0.2 mg/kg suspension q.i.d.for 8 weeks. Receives: Drug: Cisapride |
| 002 | Placebo comparator | Placebo Suspension identical in appearance to cisapride q.i.d. for 8 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver's assessment of infant pediatric GORD symptoms
Measured: Up to 8 weeks (56 days)
Secondary outcomes (1)
The number and type of adverse events reported
Measured: From time of first dose to the last dose (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 posted24 Jan 2011 (estimated)
- Study startSep 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 Gastroesophageal RefluxStudies 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
- 6 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
- NCT01281553
- Sponsor's protocol ID
- CR003952
- Other IDs
- CIS-INT-27
- 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 0.2 mg/kg q.i.d.) for the Treatment of Symptomatic Gastro-Oesophageal Reflux Disease (GORD) in Infants and Children
- ClinicalTrials.gov ID
- NCT01281553
- Acronym / sponsor ID
- CR003952
- Conditions
- Gastroesophageal Reflux
- Keywords
- Cisapride (PREPULSID), Placebo, Gastroesophageal Reflux Disease (GERD), Gastro-oesophageal Reflux Disease (GORD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor request
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Oct 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 compare the efficacy and tolerability of cisapride with placebo in infants and children with gastro-oesophageal reflux disease (GORD).
Detailed description
This is a double-blind (neither patient nor study staff will know the identity of the assigned treatment) study evaluate the effectiveness and safety of cisapride in patients with gastro-oesophageal reflux disease (GORD) (also referred to as gastroesophageal reflux disease [GERD[) compared to a placebo (a identical in appearance to cisapride but does not contain active drug). Patients will receive placebo or cisapride suspension at 0.2 mg/kg (volumn determined by patient weight) four times per day (q.i.d.) (15 minutes before feeding 3 times a day and at bedtime) orally (by mouth) for 8 weeks.
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 suspension q.i.d.for 8 weeks. |
| 002 | Placebo comparator | Drug: PlaceboPlacebo Suspension identical in appearance to cisapride q.i.d. for 8 weeks. |
Who may qualify
- Ages
- 1 month to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of GORD based on protocol-specified characteristics
- Failed the 1st of 5 stepwise treatments for GORD recommended by the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)
- Caregiver able to complete the I-GERQ-R questionnaire
Key exclusion criteria (3 listed)
- Protocol-specified respiratory conditions requiring previous or current treatment with oral or intravenous corticosteroids (prior and concurrent use of inhaled corticosteroids is acceptable)
- Cause of vomiting/regurgitation other than GORD
- Prior history of cisapride intake
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 |
|---|---|---|
| PlaceboSuspension identical in appearance to cisapride q.i.d. for 8 weeks. | Drug | 002 |
| Cisapride0.2 mg/kg suspension q.i.d.for 8 weeks. | Drug | 001 |
Primary outcome
Caregiver's assessment of infant pediatric GORD symptoms
Time frame: Up to 8 weeks (56 days)
1 secondary outcome
The number and type of adverse events reported
Time frame: From time of first dose to the last dose (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 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 Gastroesophageal Reflux, 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 3 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?
Caregiver's assessment of infant pediatric GORD symptoms (time frame: Up to 8 weeks (56 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.