The effect on mucosal healing with Pentasa® Sachet 4 g in mild to moderate active small bowel Crohn's disease, evaluated with video capsule endoscopy after 6 and 12 weeks treatment. A pilot study. - N.A.

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-002472-15-SE
• Date of registration: 23/06/2005
• Prospective Registration: Yes
• Primary sponsor: Ferring Laegemidler A/S
• Public title: The effect on mucosal healing with Pentasa® Sachet 4 g in mild to moderate active small bowel Crohn's disease, evaluated with video capsule endoscopy after 6 and 12 weeks treatment. A pilot study. - N.A.
• Scientific title: The effect on mucosal healing with Pentasa® Sachet 4 g in mild to moderate active small bowel Crohn's disease, evaluated with video capsule endoscopy after 6 and 12 weeks treatment. A pilot study. - N.A.
• Date of first enrolment: 22/09/2005
• Target sample size: 10
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002472-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: Other trial design description: investigator blinded, prospective, uncontrolled pilot study If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
Patients who have signed the informed consent form
Patients with performed complete VCE=7 days prior to inclusion and diagnosed clinically active mild to moderate small bowel CD and no stricture on previous exaninations, as previously proven by barium small bowel follow through, enteroclysis and / or patency test capsule and with visualization of the entire small bowel.
Patients between 18 - 70 years of age
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Patients with evidence of other forms of inflammatory bowel disease, idiopathic proctitis or infectious disease.
2. Patients with known strictures from previous examinations with for instance barium small bowel follow through, enteroclysis and / or patency capsule test.
3. Patients with laboratory values outside normal ranges according to the clinic routines.
4. Patients with pacemaker due to lack of VCE interaction data.
5. Patients who cannot undergo study procedures due to swallowing disorders.
6. Planned or actual pregnancy or lactation.

7. Women of child-bearing potential who are not using an effective method of contraception, in the opinion of the investigator.

8. Patients receiving maintenance treatment (p.o.) with total daily doses above 2.0g of sulphasalazine, mesalazine or 4-ASA, for 30 days prior to entry into the study.

9. Chronic use of non-steroidal anti-inflammatory drugs (oral and/or rectal routes) in the seven days prior to inclusion in the study (chronic use is defined as drug intake for a minimum of 3 consecutive days).

10. Intake of corticosteroids (oral and/or rectal routes) within the 30 days prior to enrolment in the study.

11. Patients receiving any immunosuppressive (azathioprine, 6-MP, etc) agents during 30 days prior to study enrolment.

12. Patients receiving any Crohn specific biological agents (TNF-alfa) during the last year prior to study enrolment.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Mild to moderate active Crohn's disease
MedDRA version: 7.1 Level: PT Classification code 10011401

Intervention(s)

Trade Name: Pentasa Sachet 1 g prolonged release granules
Product Name: Pentasa Sachet 1 g
Pharmaceutical Form: Prolonged-release granules
INN or Proposed INN: mesalazine
Other descriptive name: 5-Aminosalicylic acid
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-

Primary Outcome(s)

Secondary Objective: CDAI changes, laboratory changes

Main Objective: To visualize the healing effect on mucosal lesions with Pentasa Sachet 4 g in patients with mild to moderate active small bowel CD.

Primary end point(s): Mucosal changes, (measured as number, type and localization of small bowel mucosal lesions detected by VCE) from baseline (i.e. =7 days prior to inclusion), and after 6 and 12 weeks' treatment with Pentasa Sachet 4 g.

Secondary ID(s)

FE999907 CS004