Urinary excretion levels of MMX-mesalazine in healthy volunteers
| ISRCTN | ISRCTN15765858 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15765858 |
| Secondary identifying numbers | 42016.091.12 |
- Submission date
- 05/02/2015
- Registration date
- 24/02/2015
- Last edited
- 12/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
Department of Gastroenterology & Hepatology
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Urinary excretion levels of MMX-mesalazine in healthy volunteers: a non-randomised study |
| Study objectives | 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(s) | Ethics Committee of Radboud University Medical Center, Nijmegen, the Netherlands |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | MMX-mesalazine |
| Primary outcome measure | 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 study start date | 24/07/2013 |
| Completion date | 13/01/2014 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 25 |
| Key inclusion criteria | 1. > 18 years 2. No comorbidity 3. No relevant co-medication especially NSAIDs or aspirin 4. Not pregnant |
| Key exclusion criteria | 1. Pregnancy 2. Relevant co-morbidity 3. Relevant co-medication |
| Date of first enrolment | 24/07/2013 |
| Date of final enrolment | 11/11/2013 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Nijmegen
6525 GA
Netherlands
Sponsor information
Hospital/treatment centre
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
"ROR" |
https://ror.org/05wg1m734 |
|---|
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Shire Pharmaceuticals
- Location
- Ireland
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | |
| IPD sharing plan |
