Crohn's DiseasePhase 2NCT00417690
High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease
A Phase 2 study testing 4-Aminosalicylic acid in people with Crohn's Disease, run by Jacobus Pharmaceutical at 5 sites in 2 countries.
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 4 grams three times daily for 2 weeks followed by 4 grams twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- 4-Aminosalicylic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jan 2007to Oct 2008
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- Crohn's disease involving predominantly 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, including budesonide
- Corticosteroids within the previous 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
- Change in dose during previous 4 weeks in 5-aminosalicylate, probiotic and/or antibiotic, or in chronic azathioprine, 6-mercaptopurine, or methotrexate
- If currently using azathioprine, 6-mercaptopurine or methotrexate, these must have been used steadily for at least 4 months
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- Current experimental drugs or experimental drugs within the last 3 months
- If the severity of the flare has started to decrease spontaneously
- Coexisting diagnosis of primary sclerosing cholangitis,
- Infectious diarrhea,
- Signs of intestinal obstruction or perforation or abscess,
- New fistulization as part of the acute flare or increased activity in chronic fistula(e) as part of the acute flare,
- Increased activity of pre-existing anal or rectal Crohn's disease as part of the flare
- Allergy or sensitivity to salicylates
- Pregnancy or breast-feeding
- Failure of a woman of child-bearing age to agree to use adequate contraception for the 4 week period of the trial, if sexually active
- Severe renal or hepatic disease
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, 28207
The University of Chicago
Chicago, Illinois, 60637
Mount Sinai School of Medicine IBD Research Center
New York, New York, 10028
Israel2 sites
Rambam Medical Center
Haifa, 31096
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
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 4 grams three times daily for 2 weeks followed by 4 grams twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.
- Conditions
- Crohn's Disease
- Being tested
- 4-Aminosalicylic acid, PASER placebo granules
- Keywords
- Crohn's Disease, Acute Flare, Mild to moderate Crohn's Disease, Ileocecal distribution
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-Aminosalicylic acidDrug
Also called PASER Granules, NDC 49938-107-04
Oral granules administered as one 4 g packet three times daily for two weeks followed by one 4 g packet two times daily for two weeks
PASER placebo granulesDrug
Oral granules administered administered as one packet three times daily for two weeks followed by one packet two times daily for two weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Oral granules administered as one 4 g packet three times daily for two weeks followed by one 4 g packet two times daily for two weeks Receives: Drug: 4-Aminosalicylic acid |
| P | Placebo comparator | One packet of oral granules administered three times daily for 2 weeks followed by one packet two times daily for two weeks Receives: Drug: PASER placebo granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response, as defined by a reduction of the CDAI score of >70 points by 4 weeks compared with baseline
Measured: 4 weeks
Secondary outcomes (10)
Rate of remission as defined by the decrease in CDAI > 100 points and total CDAI < 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
Increase in IBDQ to greater than 170 and the time to score above 170
Measured: 4 weeks
The change from baseline in the patient's general sense of disease activity as recorded in the individual daily diary
Measured: up to 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 posted4 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionDec 2007
- 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.
- 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacobus Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David P. Jacobus, MD, Study chair, Jacobus PharmaceuticalKathy L. Ales, MD, Study director, Jacobus PharmaceuticalDaniel Present, MD, Principal investigator, Icahn School of Medicine at Mount SinaiStephen B. Hanauer, MD, Principal investigator, University of Chicago HospitalsJohn Hanson, MD, Principal investigator, Charlotte Gastroenterology & Hepatology, PLLCIris Dotan, MD, Principal investigator, Tel-Aviv Sourasky Medical CenterRami Eliakim, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417690
- Sponsor's protocol ID
- PASER-AFC.001
- Status last verified
- Oct 2008
- First submitted
- 2 Jan 2007
- Last updated
- 15 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2008. 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
- NCT00417690
- Acronym / sponsor ID
- PASER-AFC.001
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, Acute Flare, Mild to moderate Crohn's Disease, Ileocecal distribution
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Efforts at recruitment have halted as recruitment was poor.
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Jacobus PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 4 Jan 2007 (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 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 4 grams three times daily for 2 weeks followed by 4 grams twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.
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 |
|---|---|---|
| A | Experimental | Drug: 4-Aminosalicylic acidOral granules administered as one 4 g packet three times daily for two weeks followed by one 4 g packet two times daily for two weeks |
| P | Placebo comparator | Drug: PASER placebo granulesOne packet of oral granules administered three times daily for 2 weeks followed by one packet two times daily for two weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65
- Crohn's disease involving predominantly 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 (17 listed)
- Concomitant corticosteroids, including budesonide
- Corticosteroids within the previous 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
- Change in dose during previous 4 weeks in 5-aminosalicylate, probiotic and/or antibiotic, or in chronic azathioprine, 6-mercaptopurine, or methotrexate
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 acidAlso: PASER Granules, NDC 49938-107-04Oral granules administered as one 4 g packet three times daily for two weeks followed by one 4 g packet two times daily for two weeks | Drug | A |
| PASER placebo granulesOral granules administered administered as one packet three times daily for two weeks followed by one packet two times daily for two weeks | Drug | P |
Primary outcome
Response, as defined by a reduction of the CDAI score of >70 points by 4 weeks compared with baseline
Time frame: 4 weeks
10 secondary outcomes
Rate of remission as defined by the decrease in CDAI > 100 points and total CDAI < 150 by 4 weeks
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
Increase in IBDQ to greater than 170 and the time to score above 170
Time frame: 4 weeks
The change from baseline in the patient's general sense of disease activity as recorded in the individual daily diary
Time frame: up to 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
The study was stopped early (reason given: Efforts at recruitment have halted as recruitment was poor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2008.
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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
Daniel Present, MD principal investigator
Icahn School of Medicine at Mount Sinai
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 4-Aminosalicylic acid in people with Crohn's Disease, run by Jacobus Pharmaceutical at 5 sites in 2 countries.
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 17 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 15 Oct 2008. 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, Israel. 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?
The study was stopped early (reason given: Efforts at recruitment have halted as recruitment was poor.). 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?
Response, as defined by a reduction of the CDAI 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 15 Oct 2008.