Condition category
Not Applicable
Date applied
16/12/2014
Date assigned
18/12/2014
Last edited
16/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marina Maurer

ORCID ID

Contact details

University Medical Centre Groningen
HPC EB70
Hanzeplein 1
Groningen
9713 GZ
Netherlands

Additional identifiers

EudraCT number

2009-013471-21

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

BIOCOP-2

Study hypothesis

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

Ethics boards of the University Medical Center Groningen, 19/11/2010, ref: 2009.188

Study design

Prospective bioavailability study (cross-over) in healthy volunteers and Crohn's patients

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2009

Overall trial end date

20/04/2011

Reason abandoned

Eligibility

Participant 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)

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

32

Participant 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


Recruitment start date

25/01/2011

Recruitment end date

01/04/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen
HPC EB70 Hanzeplein 1
Groningen
9713 GZ
Netherlands

Sponsor information

Organisation

University Medical Center Groningen

Sponsor details

Hanzeplein 1
Groningen
9713 GZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Invesitigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

IntelliCap systems were provided by Medimetrics Personalized Drug Delivery BV Eindhoven (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

01/01/2015

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24096020
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26177019

Publication citations

Additional files

Editorial Notes