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TerminatedNCT00245505Updated Mar 12, 2012

The Effect on Mucosal Healing With Pentasa Sachet in Mild to Moderate Active "Drug: Crohn's Disease"

A Phase 3 interventional study of Mesalazine (Mesalamine) in Crohn's Disease, sponsored by Ferring Pharmaceuticals. Terminated at 1 site in Sweden. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-03-12.

Sponsored by Ferring Pharmaceuticals · Phase 3, Interventional, and Treatment

Why this study was terminated
Study terminated due to lack of eligible patients
Phase
Phase 3
Study type
Interventional
Enrollment
3
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to visualize the healing effect on mucosal lesions with Pentasa Sachet 4g in patients with mild to moderate active small bowel CD by video capsule endoscopy.

Read the detailed description

The purpose of this study is to visualize the healing effect on mucosal lesions with Pentasa Sachet 4g in patients with mild to moderate active small bowel CD by video capsule endoscopy

02

Conditions studied

  • Crohn's Disease

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03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 3 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 13 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients who have signed the informed consent form
  2. 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 examinations, as previously proven by barium small bowel follow through, enteroclysis and / or patency test capsule.
  3. Patients between 18 - 70 years of age.

Exclusion criteria

4.3 Exclusion Criteria

  1. Patients with evidence of other forms of inflammatory small bowel bowel disease, idiopathic proctitis or infectious disease.
  2. Patients with known small bowel strictures from previous examinations with for instance barium small bowel follow through, enteroclysis and / or patency capsule test.
  3. Patients with pacemaker due to lack of VCE interaction data.
  4. Patients who cannot undergo study procedures due to swallowing disorders.
  5. Planned or actual pregnancy or lactation.
  6. Women of child-bearing potential who are not using an effective method of contraception, in the opinion of the investigator.
  1. 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.
  1. Chronic use of non-steroidal anti-inflammatory drugs (oral and/or rectal routes) in 30 days prior to inclusion in the study (chronic use is defined as drug intake for a minimum of 3 consecutive days).
  1. Intake of corticosteroids (oral and/or rectal routes) within the 30 days prior to enrolment in the study.
  1. Patients receiving any immunosuppressive (azathioprine, 6-MP, etc) agents during 30 days prior to study enrolment.
  1. Patients receiving any Crohn specific biological agents (TNF-alfa) during the last year prior to study enrolment.
  1. Patients with any other disease or condition which may interfere with study assessments as judged by the investigator.
  1. Alcoholism or drug addiction. 15. Patients participating or having participated in another clinical study in the previous 30 days.
  1. Patients with severe renal/hepatic impairment (see section 5.6) as judged by the investigator.
  1. Patients who are allergic to salicylate or 5-ASA derivatives. 18. Patients who are unlikely to comply with the protocol. 19. Any patient who has previously taken part in this study. 20. Patients who are unable to write or read local language
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Interventions

  • DrugMesalazine (Mesalamine)

    Pentasa (mesalazine) sachets 2 g morning + 2 g evening during 12 weeks treatment

06

What researchers measure

Primary outcomes

  1. 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 4g Pentasa Sachet

    Time frame: 12 weeks

Secondary outcomes

  1. CDAI changes and laboratory changes

    Time frame: 12 weeks

07

Study locations

1 site
  • Department of Medicine, Malmö University Hospital
    Malmo, Malmö SE-205 02, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00245505
Lead sponsor
Ferring Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 28, 2005
Start date
Feb 2009
Primary completion
Jun 2009
Completion
Jul 2009
Last update
Mar 12, 2012

Study contacts

Clinical Development Support
study director · Ferring Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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