Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment

NCT ID: NCT02261636

Last Updated: 2022-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-01-14

Brief Summary

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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.

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pentasa

Treatment according to standard clinical practice.

mesalazine

Intervention Type DRUG

Interventions

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mesalazine

Intervention Type DRUG

Other Intervention Names

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Pentasa

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Compliance

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Gelre Ziekenhuizen (there may be other sites in this country)

Zutphen, , Netherlands

Site Status

Countries

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Netherlands

References

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West R, Russel M, Bodelier A, Kuijvenhoven J, Bruin K, Jansen J, Van der Meulen A, Keulen E, Wolters L, Ouwendijk R, Bezemer G, Koussoulas V, Tang T, Van Dobbenburgh A, Van Nistelrooy M, Minderhoud I, Vandebosch S, Lubbinge H. Lower Risk of Recurrence with a Higher Induction Dose of Mesalazine and Longer Duration of Treatment in Ulcerative Colitis: Results from the Dutch, Non-Interventional, IMPACT Study. J Gastrointestin Liver Dis. 2022 Mar 19;31(1):18-24. doi: 10.15403/jgld-3927.

Reference Type RESULT
PMID: 35306553 (View on PubMed)

Other Identifiers

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000157

Identifier Type: -

Identifier Source: org_study_id

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