Crohn's DiseaseNCT00004423
Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease
A study testing -aminosalicylic acid in people with Crohn's Disease, run by University of Vermont.
Trial summary
OBJECTIVES: I. Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's disease of the small bowel. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- -aminosalicylic acid
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Dec 1995to Mar 1998
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Active small bowel Crohn's disease established by clinical evaluation and prior radiologic study, endoscopy, surgical findings and/or histopathology
- Crohn's Disease Activity Index (CDAI) must be between 150 and 450
- No ulcerative or infectious colitis or severe perianal disease
--Prior/Concurrent Therapy--
- Biologic therapy: Not specified
- Chemotherapy: Stable dose of no greater than 20 mg per day of prednisone allowed
- Endocrine therapy: No immunosuppressive drugs within the past 3 months No concurrent immunosuppressive drugs
- Radiotherapy: Not specified
- Surgery: No impending surgery No prior ileostomy or colostomy
- Other: No 5-aminosalicylates within the past 2 weeks No concurrent 5-aminosalicylates No concurrent metronidazol or ciprofloxacin
--Patient Characteristics--
- Age: 18 to 80
- Performance status: Ambulatory
- Hematopoietic: Not specified
- Hepatic: No hepatic disease
- Renal: No renal disease
- Other: Not pregnant (negative pregnancy test required) Fertile patients must use effective contraception No documented salicylate allergy
About this study
OBJECTIVES:
- Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's disease of the small bowel.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized, placebo controlled, multicenter study. Patients are randomized to receive either oral 4-aminosalicylic acid (4-ASA) or placebo twice a day for 12 weeks. After 12 weeks patients who improved with 4-ASA and those who received placebo are given the option of receiving 4-ASA for an additional year.
Patients who were randomized to receive 4-ASA and continue treatment after 12 weeks are followed every 3 months for 1 year. Patients who were randomized to receive placebo and begin 4-ASA therapy after 12 weeks are followed monthly for 3 months, then every 3 months for 1 year.
Completion date provided represents the completion date of the grant per OOPD records
- Conditions
- Crohn's Disease
- Being tested
- -aminosalicylic acid
- Keywords
- Crohn's disease, gastrointestinal disorders, rare disease
- Medical subject headings
- Crohn Disease, Gastrointestinal Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
-aminosalicylic acidDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startDec 1995
- Study completionMar 1998
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Investigators
- James A. Vecchio, Study chair, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004423
- Sponsor's protocol ID
- 199/13352
- Other IDs
- UVTCM-FDR001021
- Status last verified
- Jan 2000
- First submitted
- 18 Oct 1999
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease
- ClinicalTrials.gov ID
- NCT00004423
- Acronym / sponsor ID
- 199/13352
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, gastrointestinal disorders, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Dec 1995
- Study completion
- Mar 1998
- First posted
- 19 Oct 1999 (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.
OBJECTIVES:
- Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's disease of the small bowel.
Detailed description
PROTOCOL OUTLINE: This is a randomized, placebo controlled, multicenter study. Patients are randomized to receive either oral 4-aminosalicylic acid (4-ASA) or placebo twice a day for 12 weeks. After 12 weeks patients who improved with 4-ASA and those who received placebo are given the option of receiving 4-ASA for an additional year.
Patients who were randomized to receive 4-ASA and continue treatment after 12 weeks are followed every 3 months for 1 year. Patients who were randomized to receive placebo and begin 4-ASA therapy after 12 weeks are followed monthly for 3 months, then every 3 months for 1 year.
Completion date provided represents the completion date of the grant per OOPD records
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| -aminosalicylic acid | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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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.
James A. Vecchio study chair
University of Vermont
Questions about this trial
What is this clinical trial studying?
A study testing -aminosalicylic acid in people with Crohn's Disease, run by University of Vermont.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 25 Mar 2015. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 25 Mar 2015.