Plain English Summary
Background and study aims
Ulcerative colitis (UC) is a long-term condition where the colon (large intestine) and rectum is inflamed. Ulcers can develop in the lining of the affected region of the bowel, which can then bleed and produce pus. The severity of symptoms vary according to how much of the bowel is affected but include diarrhoea (with or without blood and pus), stomach pain and the urge to empty the bowels more frequently than normal. Sufferers may not have any symptoms, or only very mild symptoms, for long periods (remission) which can then be followed by periods where the symptoms are much more severe (flare-ups or relapses). There is no cure for the condition and treatment concentrates on alleviating symptoms. Medication is usually the first line of treatment. Patients commonly take aminosalicylates (ASA) including mesalazine. These drugs can be very successful in treating UC patients, but getting people to take them regularly can be a challenge. Here, we want to test if measuring (NAc) 5-ASA in the urine can be used to see whether people are taking their MMX-mesalazine (i.e. monitoring adherence).
Who can participate?
Healthy adult volunteers aged over 18.
What does the study involve?
Participants are given 2400 mg of MMX-mesalazine once a day for 4 days. They then stop taking the drug for 3 days. This is followed by them taking 1200 mg of MMX-mesalazine twice a day for a further 4 days. All participants are supervised when taking the drug to ensure full adherence. Daily urine spot samples are taken from each participant throughout the study before they take the medication.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Radboud University Nijmegen Medical Centre (Netherlands)
When is the study starting and how long is it expected to run for?
July 2013 to January 2014
Who is funding the study?
1. Shire (Ireland)
2. Tramedico (Netherlands)
Who is the main contact?
Dr Tessa Romkens
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
42016.091.12
Study information
Scientific title
Urinary excretion levels of MMX-mesalazine in healthy volunteers: a non-randomised study
Acronym
Study hypothesis
1. High-performance liquid chromatography (HPLC) is a feasible, sensitive and reproducible method to measure urinary (NAc-) 5-ASA excretion in volunteers taking MMX-mesalazine.
2. The (Nac)5-ASA urinary excretion cut-off-level for adherence was determined
Ethics approval
Ethics Committee of Radboud University Medical Center, Nijmegen, the Netherlands
Study design
25 healthy volunteers are studied during 14 days, using 2 different dosage schedules of MMX-mesalazine
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Urinary excretion MMX-mesalazine, pharmacokinetics. Now studied in healthy volunteers. To be used in inflammatory bowel disease (IBD) patients in the future.
Intervention
All 25 healthy adult volunteers used MMX-mesalazine ( 2400 mg once daily (OD) (days 1-4), followed by 1200 mg twice daily (BID) (days 8-11), separated by a drug-free interval of 3 days (days 5-7). Daily morning urine spot samples were collected prior to the morning dose.
Intervention type
Drug
Phase
Drug names
MMX-mesalazine
Primary outcome measures
1. Feasibility, sensitivity, and reproducibility of high-performance liquid chromatography (HPLC) to measure urinary (NAc-) 5-ASA excretion in healthy volunteers taking MMX mesalazine
2. Adherence: The cut-off-level for adherence was defined as the total (Nac)5-ASA urinary excretion level, as measured in at least 95% of the subjects, taking 2400 mg MMX-mesalazine OD or BID
Secondary outcome measures
Adverse events
Overall trial start date
24/07/2013
Overall trial end date
13/01/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. > 18 years
2. No comorbidity
3. No relevant co-medication especially NSAIDs or aspirin
4. Not pregnant
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
25
Participant exclusion criteria
1. Pregnancy
2. Relevant co-morbidity
3. Relevant co-medication
Recruitment start date
24/07/2013
Recruitment end date
11/11/2013
Locations
Countries of recruitment
Netherlands
Trial participating centre
Radboud University Nijmegen Medical Centre
Geert Grooteplein-Zuid 10
Nijmegen
6525 GA
Netherlands
Funders
Funder type
Industry
Funder name
Shire
Alternative name(s)
Shire Pharmaceuticals
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
Ireland
Funder name
Tramedico (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary