Crohn's DiseasePhase 2NCT00495521
High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children
A Phase 2 study testing 4-Aminosalicylic acid extended release granules in people with Crohn's Disease, run by Jacobus Pharmaceutical at 5 sites in United States.
Trial summary
The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- 4-Aminosalicylic acid extended release granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2007to Oct 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age less than 18 years
- Crohn's disease predominantly involving the ileum and/or cecum. The diagnosis must have been established by radiography, endoscopy and/or biopsy (at least 2 of the 3 modalities) with at least one confirmatory test having been performed no more than 36 months before entry. The diagnosis must have been confirmed by at least one gastroenterologist.
- Harvey Bradshaw Index of at least 7
- The onset of the acute flare should have been abrupt, declaring itself over 72 hours, and should have started no more than 4 weeks before study entry. Symptoms relating to the flare should not have diminished or started to improve prior to entry.
- Written informed consent
Who cannot join
- Concomitant corticosteroids, budesonide
- Corticosteroids within 2 months
- Cyclosporine, mycophenolate mofetil or experimental drugs during the last three months
- Maintenance infliximab, or infliximab or other biologics in the preceding 3 months
- If the severity of the flare has started to decrease spontaneously
- Coexisting diagnosis of primary sclerosing cholangitis
Show all 13Show fewer
- Infectious diarrhea
- Signs of intestinal obstruction or perforation
- New fistulization as part of the acute flare or increased activity in chronic fistula(e) as part of the acute flare
- Hypersensitivity to 4-ASA or any components of PASER®
- Pregnancy or breast-feeding
- Failure of a woman of child-bearing potential to agree to use adequate contraception for the 4 week period of the trial, if sexually active
- Severe renal or hepatic disease (i.e., more than 3 times upper limit of normal) or a WBC < 3,000 during the preceding three months
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Children's Center for Digestive HealthCare, LLC
Atlanta, Georgia, 30342
Texas Children's Hospital, Baylor College of Medicine
Houston, Texas, 77030
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Atlantic Health System / Morristown Memorial Hospital / Goryeb Children's Hospital
Morristown, New Jersey, 07962
University of California, San Francisco
San Francisco, California, 94143-0316
About this study
Official title: A Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's Disease
The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.
Read the detailed description
Eligible pediatric patients with acute flares of ileocecal Crohn's disease will be randomized to receive either PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, or an identical-appearing placebo preparation.
Patients will be required to maintain a daily diary and to return at 2 weeks for blood and stool tests. At the four week mark, patients will return for clinical evaluation, global assessment of disease activity and change in disease activity, as well as additional laboratory tests.
- Conditions
- Crohn's Disease
- Being tested
- 4-Aminosalicylic acid extended release granules
- Keywords
- Crohn's, Crohn's Disease, Acute Flare, Mild to Moderate Crohn's Disease, Children, Pediatrics, Ileo-cecal, Pediatric Crohn's Disease, New Onset Crohn's Disease, Recently diagnosed Crohn's Disease
- Medical subject headings
- Crohn Disease, Pediatric Crohn's disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-Aminosalicylic acid extended release granulesDrug
Also called PASER® Granules (or Placebo Granules), 4-Aminosalicylic acid, NDC 49938-107-04, 4-ASA
Granules for oral administration will be administered as a volume equivalent to 50 mg/kg of 4-aminosalicylic acid three times daily for 2 weeks followed by 2 times daily for 2 weeks in the active arm or a comparable volume in the placebo arm
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | 4-Aminosalicylic acid extended release granules (as volume equivalent of active product), 50 mg/kg orally three times daily for two weeks followed by (as volume equivalent) 50 mg/kg orally two times daily for 2 weeks Receives: Drug: 4-Aminosalicylic acid extended release granules |
| Placebo | Placebo comparator | Placebo granules identical in appearance to the active arm (as volume equivalent of active product), 0 mg/kg orally three times daily for two weeks followed by (as volume equivalent) 0 mg/kg orally two times daily for 2 weeks Receives: Drug: 4-Aminosalicylic acid extended release granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the Modified Crohn's Disease Activity Index (mCDAI) Score of >70 Points by 4 Weeks Compared With Baseline
Reduction in the Modified Crohn's Disease Activity Index (mCDAI) score of >70 points by 4 weeks after randomization compared with baseline
Measured: 4 weeks
Secondary outcomes (12)
Rate of Remission
Rate of remission was defined by a decrease in modified Crohn's Disease Activity Index (mCDAI) > 100 points and total mCDAI < 150 by 4 weeks
Measured: 4 weeks
Rate of Response as Defined by a Reduction in HBI to Less Than 5 by 4 Weeks
Measured: 4 weeks
Rate of Remission as Defined by the Decrease in HBI to Less Than 3 by 4 Weeks
Measured: 4 weeks
Time to Response and/or Remission Including Time to Change in HBI, According to Elements of the Daily Patient Diary
Measured: up to 4 weeks
Rate of Response as Defined by the Decrease in PCDAI of 12.5 Points by 4 Weeks
Measured: 4 weeks
Rate of Remission as Defined by the Decrease in PCDAI < 10 by 4 Weeks
Measured: 4 weeks
Change in IMPACT-III From Baseline to 4 Weeks
Measured: 4 weeks
Change From Baseline in the Patient's General Sense of Disease Activity as Recorded in the Individual Daily Diary
Measured: 4 weeks
Absence of Night Time Stools, if They Were Present on Entry, and Time to Disappearance
Measured: up to 4 weeks
Time to Normalization of All Other Components in the Diary
Measured: up to 4 weeks
Change in Hgb, ESR, CRP, Platelet Count, Calprotectin From Baseline and Time to Normalization
Measured: 2 weeks and 4 weeks
Change in Global Physician Assessment of Disease Activity From Baseline to Study Completion
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionJul 2008
- Study completionOct 2008
Why it stopped: Efforts at recruitment have halted as recruitment was poor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacobus Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David P Jacobus, MD, Study chair, Jacobus PharmaceuticalKathy L Ales, MD, Study director, Jacobus PharmaceuticalGeorge D Ferry, MD, Principal investigator, Texas Children's Hospital, Baylor College of MedicineMarla C Dubinsky, MD, Principal investigator, Cedars-Sinai Medical CenterJoel R Rosh, MD, Principal investigator, Atlantic Health System, Morristown General Hospital, Goryeb Children's HospitalMelvin B. Heyman, M.D., M.P.H., Principal investigator, University of California, San FranciscoStanley A. Cohen, M.D., Principal investigator, Children's Center for Digestive Healthcare, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495521
- Sponsor's protocol ID
- PASER - AFC.002
- Status last verified
- Aug 2017
- First submitted
- 29 Jun 2007
- Last updated
- 21 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's Disease
- ClinicalTrials.gov ID
- NCT00495521
- Acronym / sponsor ID
- PASER - AFC.002
- Conditions
- Crohn's Disease
- Keywords
- Crohn's, Crohn's Disease, Acute Flare, Mild to Moderate Crohn's Disease, Children, Pediatrics, Ileo-cecal, Pediatric Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Efforts at recruitment have halted as recruitment was poor
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Jacobus PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 3 Jul 2007 (estimated)
- Results
- Posted 21 Sep 2017
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 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.
Detailed description
Eligible pediatric patients with acute flares of ileocecal Crohn's disease will be randomized to receive either PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, or an identical-appearing placebo preparation.
Patients will be required to maintain a daily diary and to return at 2 weeks for blood and stool tests. At the four week mark, patients will return for clinical evaluation, global assessment of disease activity and change in disease activity, as well as additional laboratory tests.
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 |
|---|---|---|
| Active | Experimental | Drug: 4-Aminosalicylic acid extended release granules4-Aminosalicylic acid extended release granules (as volume equivalent of active product), 50 mg/kg orally three times daily for two weeks followed by (as volume equivalent) 50 mg/kg orally two times daily for 2 weeks |
| Placebo | Placebo comparator | Drug: 4-Aminosalicylic acid extended release granulesPlacebo granules identical in appearance to the active arm (as volume equivalent of active product), 0 mg/kg orally three times daily for two weeks followed by (as volume equivalent) 0 mg/kg orally two times daily for 2 weeks |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age less than 18 years
- Crohn's disease predominantly involving the ileum and/or cecum. The diagnosis must have been established by radiography, endoscopy and/or biopsy (at least 2 of the 3 modalities) with at least one confirmatory test having been performed no more than 36 months before entry. The diagnosis must have been confirmed by at least one gastroenterologist.
- Harvey Bradshaw Index of at least 7
- The onset of the acute flare should have been abrupt, declaring itself over 72 hours, and should have started no more than 4 weeks before study entry. Symptoms relating to the flare should not have diminished or started to improve prior to entry.
- Written informed consent
Key exclusion criteria (13 listed)
- Concomitant corticosteroids, budesonide
- Corticosteroids within 2 months
- Cyclosporine, mycophenolate mofetil or experimental drugs during the last three months
- Maintenance infliximab, or infliximab or other biologics in the preceding 3 months
- If the severity of the flare has started to decrease spontaneously
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 |
|---|---|---|
| 4-Aminosalicylic acid extended release granulesAlso: PASER® Granules (or Placebo Granules), 4-Aminosalicylic acid, NDC 49938-107-04, 4-ASAGranules for oral administration will be administered as a volume equivalent to 50 mg/kg of 4-aminosalicylic acid three times daily for 2 weeks followed by 2 times daily for 2 weeks in the active arm or a comparable volume in the placebo arm | Drug | Active, Placebo |
Primary outcome
Reduction in the Modified Crohn's Disease Activity Index (mCDAI) Score of >70 Points by 4 Weeks Compared With Baseline
Time frame: 4 weeks
Reduction in the Modified Crohn's Disease Activity Index (mCDAI) score of >70 points by 4 weeks after randomization compared with baseline
12 secondary outcomes
Rate of Remission
Time frame: 4 weeks
Rate of Response as Defined by a Reduction in HBI to Less Than 5 by 4 Weeks
Time frame: 4 weeks
Rate of Remission as Defined by the Decrease in HBI to Less Than 3 by 4 Weeks
Time frame: 4 weeks
Time to Response and/or Remission Including Time to Change in HBI, According to Elements of the Daily Patient Diary
Time frame: up to 4 weeks
Rate of Response as Defined by the Decrease in PCDAI of 12.5 Points by 4 Weeks
Time frame: 4 weeks
Rate of Remission as Defined by the Decrease in PCDAI < 10 by 4 Weeks
Time frame: 4 weeks
Change in IMPACT-III From Baseline to 4 Weeks
Time frame: 4 weeks
Change From Baseline in the Patient's General Sense of Disease Activity as Recorded in the Individual Daily Diary
Time frame: 4 weeks
Absence of Night Time Stools, if They Were Present on Entry, and Time to Disappearance
Time frame: up to 4 weeks
Time to Normalization of All Other Components in the Diary
Time frame: up to 4 weeks
Change in Hgb, ESR, CRP, Platelet Count, Calprotectin From Baseline and Time to Normalization
Time frame: 2 weeks and 4 weeks
Change in Global Physician Assessment of Disease Activity From Baseline to Study Completion
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
David P Jacobus, MD study chair
Jacobus Pharmaceutical
Kathy L Ales, MD study director
Jacobus Pharmaceutical
George D Ferry, MD principal investigator
Texas Children's Hospital, Baylor College of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 4-Aminosalicylic acid extended release granules in people with Crohn's Disease, run by Jacobus Pharmaceutical at 5 sites in United States.
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 5 inclusion and 13 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 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reduction in the Modified Crohn's Disease Activity Index (mCDAI) Score of >70 Points by 4 Weeks Compared With Baseline (time frame: 4 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 21 Sep 2017.