Ulcerative ColitisPhase 2NCT04032652
Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving Asacol
A Phase 2 study testing Rectal dialysis in people with Ulcerative Colitis, run by Endeavor Health.
Trial summary
The investigators plan to develop a novel method of estimating 5-ASA levels in the rectum at a mucosal level using in vivo rectal dialysis technique towards the eventual goal of determining the optimal dosing of Asacol® that would provide therapeutic levels of 5-ASA in the left colon. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Rectal dialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to 5 Dec 2014
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eligible subjects would be healthy males and females
- 18-45 years of age (inclusive)
- Within 20% of normal body weight at screening
- Who are able to give written informed consent.
Who cannot join
- History of any chronic illness
- Evidence of significant organic or psychiatric disease on a brief health questionnaire
- A history or presence of any condition causing malabsorption or an effect on gastrointestinal motility
- A history of any gastrointestinal surgery
- A history of acute or chronic renal insufficiency
- Pre existing liver disease
- A history of severe allergic reaction to salicylates, aminosalicylates or any of the ingredients of Asacol® tablets or a history of multiple food/drug allergies or if they are pregnant or lactating.
- Subjects will be required to refrain from any prescription or nonprescription drug or herbal products except their birth control medications for gastrointestinal disorders for 7 days prior to dosing and during the study, till its completion at the end of the fifth visit.
About this study
Official title: Measurement of Rectal Levels of 5-aminosalicylic Acid (5-ASA) Using a Novel In-vivo Rectal Dialysis Technique in Healthy Volunteers on Asacol
The investigators plan to develop a novel method of estimating 5-ASA levels in the rectum at a mucosal level using in vivo rectal dialysis technique towards the eventual goal of determining the optimal dosing of Asacol® that would provide therapeutic levels of 5-ASA in the left colon.
Read the detailed description
Asacol® is mesalazine in a pH-dependent tablet (Eudragit S) that remains intact until reaching the terminal ileum. The tablet dissolves at a pH 7 or greater, allowing mesalazine release in the terminal ileum and throughout the colon; hence, it would be anticipated that this form of 5-ASA will produce higher concentrations in the left colon in patients with active ulcerative colitis compared to other immediate release forms of 5-ASA. However, preliminary research using dynamic computer modeling and simulation predicted that patients with active ulcerative colitis (characterized by an increased stool frequency) treated with Asacol® and Lialda (another delayed release formulation) will achieve very low 5-ASA levels in the sigmoid colon and rectum. The model predicts that these 5-ASA preparations will be relatively ineffective in treating the left side of the colon in active ulcerative colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- Rectal dialysis
- Keywords
- Pharmacokinetics, Aminosalicylates, Mucosal levels, Rectal dialysis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal dialysisProcedure or surgery
Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels
Rectal dialysisDrug
Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels
| Study group | Role | What they receive |
|---|---|---|
| 1200 mg Asacol once daily for 1 week | Active comparator | Rectal dialysis will be done after 1 week on 1200 mg asacol Receives: Procedure: Rectal dialysis; Drug: Rectal dialysis |
| 2400 mg Asacol once daily for 1 week | Active comparator | Rectal dialysis will be done after 1 week on 2400 mg asacol Receives: Procedure: Rectal dialysis; Drug: Rectal dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of 5-ASA
5-ASA to be measured using rectal dialysis technique in-vivo
Measured: 2 weeks after starting Asacol
Secondary outcomes (1)
Change in Detected 5-ASA With Change in Ingested Asacol Dose
Comparison of 2-week and 5-week 5-ASA as measured thorugh rectal dialysis
Measured: 5 weeks after starting study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study startDec 2012
- Primary completionNov 2014
- Study completion5 Dec 2014
Why it stopped: Insufficient enrollment
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eli D Ehrenpreis, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032652
- Sponsor's protocol ID
- EH 11-364
- Status last verified
- Sep 2019
- First submitted
- 4 Dec 2012
- Last updated
- 15 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Stobaugh DJ, Deepak P, Thorpe M, Hannon B, Ehrenpreis ED. Simulated comparison of topical and oral formulations of 5-aminosalicylate for the treatment of ulcerative colitis. Inflamm Bowel Dis. 2013 Feb;19(2):301-8. doi: 10.1002/ibd.23003.
PubMed 22644716Reissman P, Ehrenpreis ED, Cohen S, Nogueras JJ, Zaitman D, Wexner SD. Electrolyte profiles within the ileoanal pouch: measurement by an in vivo equilibrium dialysis technique. Dig Liver Dis. 2003 Apr;35(4):251-5. doi: 10.1016/s1590-8658(03)00062-8.
PubMed 12801036
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Rectal Levels of 5-aminosalicylic Acid (5-ASA) Using a Novel In-vivo Rectal Dialysis Technique in Healthy Volunteers on Asacol
- ClinicalTrials.gov ID
- NCT04032652
- Acronym / sponsor ID
- EH 11-364
- Conditions
- Ulcerative Colitis
- Keywords
- Pharmacokinetics, Aminosalicylates, Mucosal levels, Rectal dialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- 5 Dec 2014 (actual)
- First posted
- 25 Jul 2019 (actual)
- Results
- Posted 15 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators plan to develop a novel method of estimating 5-ASA levels in the rectum at a mucosal level using in vivo rectal dialysis technique towards the eventual goal of determining the optimal dosing of Asacol® that would provide therapeutic levels of 5-ASA in the left colon.
Detailed description
Asacol® is mesalazine in a pH-dependent tablet (Eudragit S) that remains intact until reaching the terminal ileum. The tablet dissolves at a pH 7 or greater, allowing mesalazine release in the terminal ileum and throughout the colon; hence, it would be anticipated that this form of 5-ASA will produce higher concentrations in the left colon in patients with active ulcerative colitis compared to other immediate release forms of 5-ASA. However, preliminary research using dynamic computer modeling and simulation predicted that patients with active ulcerative colitis (characterized by an increased stool frequency) treated with Asacol® and Lialda (another delayed release formulation) will achieve very low 5-ASA levels in the sigmoid colon and rectum. The model predicts that these 5-ASA preparations will be relatively ineffective in treating the left side of the colon in active ulcerative colitis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1200 mg Asacol once daily for 1 week | Active comparator | Procedure: Rectal dialysis, Drug: Rectal dialysisRectal dialysis will be done after 1 week on 1200 mg asacol |
| 2400 mg Asacol once daily for 1 week | Active comparator | Procedure: Rectal dialysis, Drug: Rectal dialysisRectal dialysis will be done after 1 week on 2400 mg asacol |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Eligible subjects would be healthy males and females
- 18-45 years of age (inclusive)
- Within 20% of normal body weight at screening
- Who are able to give written informed consent.
Key exclusion criteria (8 listed)
- History of any chronic illness
- Evidence of significant organic or psychiatric disease on a brief health questionnaire
- A history or presence of any condition causing malabsorption or an effect on gastrointestinal motility
- A history of any gastrointestinal surgery
- A history of acute or chronic renal insufficiency
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 |
|---|---|---|
| Rectal dialysisRectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels | Procedure or surgery | 1200 mg Asacol once daily for 1 week, 2400 mg Asacol once daily for 1 week |
| Rectal dialysisRectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels | Drug | 1200 mg Asacol once daily for 1 week, 2400 mg Asacol once daily for 1 week |
Primary outcome
Detection of 5-ASA
Time frame: 2 weeks after starting Asacol
5-ASA to be measured using rectal dialysis technique in-vivo
1 secondary outcome
Change in Detected 5-ASA With Change in Ingested Asacol Dose
Time frame: 5 weeks after starting study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22644716Stobaugh DJ, Deepak P, Thorpe M, Hannon B, Ehrenpreis ED. Simulated comparison of topical and oral formulations of 5-aminosalicylate for the treatment of ulcerative colitis. Inflamm Bowel Dis. 2013 Feb;19(2):301-8. doi: 10.1002/ibd.23003.
- Background: PubMed 12801036Reissman P, Ehrenpreis ED, Cohen S, Nogueras JJ, Zaitman D, Wexner SD. Electrolyte profiles within the ileoanal pouch: measurement by an in vivo equilibrium dialysis technique. Dig Liver Dis. 2003 Apr;35(4):251-5. doi: 10.1016/s1590-8658(03)00062-8.
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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.
Eli D Ehrenpreis, MD principal investigator
Endeavor Health
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rectal dialysis in people with Ulcerative Colitis, run by Endeavor Health.
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 4 inclusion and 8 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 2019. 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.
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 15 Oct 2019). 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?
Detection of 5-ASA (time frame: 2 weeks after starting Asacol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04032652, which also lists 2 linked publications.
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 2019.