Bioavailability of a ColoPulse tablet
| ISRCTN | ISRCTN18301880 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18301880 |
| EudraCT/CTIS number | 2009-013471-21 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/12/2014
- Registration date
- 18/12/2014
- Last edited
- 16/07/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study will test whether the amount of active substance released from a new tablet (ColoPulse tablet) differs in patients with Crohn’s disease compared with healthy volunteers. The influence of food and the time when food is eaten after administration of the tablets will also be investigated. In the healthy volunteers the pH of their gastro-intestinal tract will be investigated with a measuring capsule (IntelliCap).
Who can participate?
Patients (age 18-65) with Crohn’s disease in remission and healthy volunteers (age 18-65) with no gastrointestinal surgery can participate in this study.
What does the study involve?
All participants will have the same tests. They come to the study facility for 2 test-days with at least one week in between. On the test day two tablets are administered simultaneously and breakfast is taken either 1 hour or 3 hours later, depending on the test day. On the second test day the healthy volunteers will also receive the IntelliCap. Data will be collected by a small recorder worn around the waist until excretion of the IntelliCap. For all subjects urine and breath samples will be taken up to 24 hours after taking the tablets. At 5.00 p.m. subjects are allowed to go home. They will take breath and urine samples themselves during the evening and next morning.
What are the possible benefits and risks of participating?
The participants have no direct benefits from participating in this study. No side effects are to be expected.
Where is the study run from?
University Medical Center Groningen, the Netherlands.
When is the study starting and how long is it expected to run for?
Recruitment for this study started in 2010 and was finished in April 2011. The study was performed in March and April 2011.
Who is funding the study?
This study was funded by the University Medical Center Groningen, the Netherlands. IntelliCaps were provided by Medimetrics, the Netherlands.
Who is the main contact?
Marina Maurer (hospital pharmacist)
m.maurer@umcg.nl
Contact information
Scientific
University Medical Centre Groningen
HPC EB70
Hanzeplein 1
Groningen
9713 GZ
Netherlands
Study information
| Study design | Prospective bioavailability study (cross-over) in healthy volunteers and Crohn's patients |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Other |
| Scientific title | BIOavailability of a COloPulse tablet in healthy volunteers and Crohn's patients; influence of gastro-intestinal pH, food and time of food intake |
| Study acronym | BIOCOP-2 |
| Study objectives | In a collaboration of UMCG and RUG a technology has been developed that allows selective delivery of drugs in the terminal ileum/proximal colon (ColoPulse technology, pH-based) after oral intake of a tablet or capsule. The ColoPulse technology has been tested in healthy volunteers. However, before a patient study with active substances can be started, it must be validated that the release profile of the formulation used is correct in the aimed population. This is the purpose of the BIOCOP-2 bioavailability study. In order to obtain additional information about the functioning of the pH-sensitive coating of the 'modified-release' tablet, the gastro-intestinal pH-profile of healthy volunteers will be determined with the help of the determined IntelliCap®. |
| Ethics approval(s) | Ethics boards of the University Medical Center Groningen, 19/11/2010, ref: 2009.188 |
| Health condition(s) or problem(s) studied | Release of a ColoPulse tablet in healthy volunteers and patients with Crohn's disease (in remission) |
| Intervention | Period 1: an oral dose of 50 mg 15N2-ureum immediate release tablet in combination with an oral dose of 50 mg 13C-ureum modified-release tablet at Day 1 in a fasted condition. Non-standardized breakfast after 1 h. Period 2: an oral dose of 50 mg 15N2-ureum immediate release tablet in combination with an oral dose of 50 mg 13C-ureum modified-release tablet at Day 1 in a fasted condition. Standardized breakfast after 3 h. Furthermore, the gastro-intestinal pH-profile of the healthy volunteer will be measured at test day 2 using the IntelliCap. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Local bioavailability in healthy volunteers and patients with Crohn's disease. 2. Time between intake and response in healthy volunteers and patients with Crohn's disease. This is the cumPDR 5%: (lagtime) at the time when release exceeds 5% of the maximum cumPDR (13 C-urea). 3. Pulse time in healthy volunteers and patients with Crohn's disease. This is the difference between times at which the maximum PDR is reached and the lagtime. 4. Description of the gastro-intestinal pH profile of healthy volunteers. |
| Secondary outcome measures | Investigate influence of food and time of food intake on functioning of a ColoPulse dosage form |
| Overall study start date | 01/01/2009 |
| Completion date | 20/04/2011 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 32 |
| Key inclusion criteria | 1. Healthy adults (18-65 years) able to sign informed consent 2. No medication use during the last 3 months that can influence the gastrointestinal flora (e.g., antibiotics) 3. No medication use during the last 4 weeks of drugs that may affect the gastrointestinal transit time (e.g., laxatives, antacids) 4. No use of NSAIDs during the last 4 weeks Patients 1. Adults (18-65 years) able to sign informed consent with Crohn's disease (in remission Harvey Bradshaw index ≤3) (18-65) 2. No medication use during the last 3 months of drugs that may affect the gastrointestinal flora (e.g., antibiotics) 3. No medication use of drugs that may affect the gastrointestinal pH (e.g., antacids) |
| Key exclusion criteria | Healthy volunteers 1. With known gastro-intestinal disorders such as ulcerative colitis, Crohn's disease, spastic colon, colon cancer, ileus, ostomy, gastric and/or intestinal infection 2. Gastrointestinal operation (except appendix operation) 3. Presence Helicobacter pylori Patients 1. Crohn's disease is in the active stage (Harvey Bradshaw ≥ 4) 2. Presence Helicobacter p ylori |
| Date of first enrolment | 25/01/2011 |
| Date of final enrolment | 01/04/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Hanzeplein 1
Groningen
9713 GZ
Netherlands
Sponsor information
Hospital/treatment centre
Hanzeplein 1
Groningen
9713 GZ
Netherlands
"ROR" |
https://ror.org/03cv38k47 |
|---|
Funders
Funder type
Other
No information available
No information available
Results and Publications
| Intention to publish date | 01/01/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/12/2013 | Yes | No | |
| Results article | results | 15/07/2015 | Yes | No |
