Ulcerative ColitisNCT00349388
Safety and Compliance of Taking Mesalamine Once a Day in Pediatric Patients
A study testing Asacol in people with Ulcerative Colitis, run by Annette Langseder at 1 site in United States.
Trial summary
To determine whether once a day administration of Mesalamine is at least as safe and efficacious and administration of multiple doses a day in preventing clinical relapse of ulcerative colitis in children and adolescence. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Asacol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jan 2011
- Phase
- Interventional
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 6 to 18 years,
- Must be able to swallow tablets, and
- Biopsy proven ulcerative colitis
Who cannot join
- Allergy or hypersensitivity to Mesalamine or other salicylates
- Use of rectal medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Morristown Memorial Hospital/Goyerb Children's Hospital
Morristown, New Jersey, 07962
About this study
Official title: A Randomized Trial Comparing Once Daily Dosing vs. Multiple Doses a Day of Mesalamine in Pediatric Patients With Quiescent Ulcerative Colitis
To determine whether once a day administration of Mesalamine is at least as safe and efficacious and administration of multiple doses a day in preventing clinical relapse of ulcerative colitis in children and adolescence.
Read the detailed description
Is taking total dose in mg/kg once a day, as safe as taking total dose divided in mg/kg spreadout during the day in preventing clinical relapse of ulcerative colitis in children and adolescence.
- Conditions
- Ulcerative Colitis
- Being tested
- Asacol
- Keywords
- Mesalamine, Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsacolDrug
Also called Mesallamine
Asacol is given once a day versus twice or three times a day
| Study group | Role | What they receive |
|---|---|---|
| Asacol once a day dosing | Experimental | Asacol total dose in mg/kg given once a day Receives: Drug: Asacol |
| Asacol BID/TID dosing | Active comparator | Asacol total dose split BID or TID Receives: Drug: Asacol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Once Daily Dosing Works as Well a Multiple Dosing a Day.
subject tolerated once a day dose Only 1 subject enrolled which was the control arm standard dose twice a day. No subjects enrolled to take dose once a day Therefore, primary outcome cannot be reported
Measured: overall study
Secondary outcomes (1)
Improved Medication Compliance.
Not applicable : unable to measure secondary outcome because no one was enrolled in once a day dose arm. Therefore, no comparisons can be made to see if once a day dosing would have higher compliance than taking medication BID or TID
Measured: overall study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: none enrolled in second arm, therfore no analysis
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Annette Langseder
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Responsible party
- Sponsor-investigator, Annette Langseder, Atlantic Health System
- Investigators
- Joel Rosh, MD, Principal investigator, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349388
- Sponsor's protocol ID
- R05-11-010
- Status last verified
- Jan 2019
- First submitted
- 5 Jul 2006
- Last updated
- 29 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Once Daily Dosing vs. Multiple Doses a Day of Mesalamine in Pediatric Patients With Quiescent Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00349388
- Acronym / sponsor ID
- R05-11-010
- Conditions
- Ulcerative Colitis
- Keywords
- Mesalamine, Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: none enrolled in second arm, therfore no analysis
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Annette LangsederUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- Jul 2006
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 7 Jul 2006 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether once a day administration of Mesalamine is at least as safe and efficacious and administration of multiple doses a day in preventing clinical relapse of ulcerative colitis in children and adolescence.
Detailed description
Is taking total dose in mg/kg once a day, as safe as taking total dose divided in mg/kg spreadout during the day in preventing clinical relapse of ulcerative colitis in children and adolescence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asacol once a day dosing | Experimental | Drug: AsacolAsacol total dose in mg/kg given once a day |
| Asacol BID/TID dosing | Active comparator | Drug: AsacolAsacol total dose split BID or TID |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Ages 6 to 18 years,
- Must be able to swallow tablets, and
- Biopsy proven ulcerative colitis
Key exclusion criteria (2 listed)
- Allergy or hypersensitivity to Mesalamine or other salicylates
- Use of rectal medications
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 |
|---|---|---|
| AsacolAlso: MesallamineAsacol is given once a day versus twice or three times a day | Drug | Asacol BID/TID dosing, Asacol once a day dosing |
Primary outcome
Once Daily Dosing Works as Well a Multiple Dosing a Day.
Time frame: overall study
subject tolerated once a day dose Only 1 subject enrolled which was the control arm standard dose twice a day. No subjects enrolled to take dose once a day Therefore, primary outcome cannot be reported
1 secondary outcome
Improved Medication Compliance.
Time frame: overall study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joel Rosh, MD principal investigator
Atlantic Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asacol in people with Ulcerative Colitis, run by Annette Langseder at 1 site 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 3 inclusion and 2 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 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Yes. Results are posted in the registry (first posted 15 Aug 2014). 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?
Once Daily Dosing Works as Well a Multiple Dosing a Day. (time frame: overall study). 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 29 Jan 2019.