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Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment

Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ulcerative Colitis

Intervention: mesalazine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals

Overall contact:
Clinical Development Support, Email: DK0-Disclosure@ferring.com

Summary

For both induction of remission and in maintenance of remission, different doses and treatment durations are used in practice. The aim of this study is to assess how mesalazine is used in clinical practice, at which doses and for how long and how these differences impact the patient disease state and work productivity.

Clinical Details

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Time to dose reduction

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with mild to moderate active ulcerative colitis with disease extension

beyond the rectum (≥ 10 cm) who will receive oral Pentasa treatment (Compact sachets and/or tablets) for the treatment of the current active episode or in whom on oral Pentasa maintenance treatment induction of remission treatment will be initiated by dose escalation. Treatment combined with Pentasa enema (1g/100ml) is allowed.

- Informed consent

Exclusion Criteria:

- Patients receiving treatment with one or more of the following: locally acting

steroids (e. g. budesonide, beclomethasone), systemic steroids, immunosuppressants (e. g. thiopurines), biologicals (e. g. anti-Tumor Necrosis Factor-alpha)

Locations and Contacts

Clinical Development Support, Email: DK0-Disclosure@ferring.com

Gelre Ziekenhuizen (there may be other sites in this country), Zutphen, Netherlands; Recruiting
Additional Information

Starting date: January 2015
Last updated: April 23, 2015

Page last updated: August 23, 2015

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