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CompletedNCT02261636IMPACTUpdated May 20, 2022

Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment

An observational study in Ulcerative Colitis, sponsored by Ferring Pharmaceuticals. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-20.

Sponsored by Ferring Pharmaceuticals · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Ulcerative Colitis
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In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 150 is above the median of 105 across 247 observational studies indexed under Colitis.

Browse Colitis 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.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Out-patient clinics in the Netherlands

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

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No

Groups and cohorts

  • Pentasa

    Treatment according to standard clinical practice.

    Drug: mesalazine

Interventions

  • Drugmesalazine

    Also known as: Pentasa

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What researchers measure

Primary outcomes

  1. Time to dose reduction

    Time frame: From Day 1 up to one year

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Study locations

1 site
  • Gelre Ziekenhuizen (there may be other sites in this country)
    Zutphen, Netherlands
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References and documents

Publications

  • 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. PubMed 35306553 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02261636
Lead sponsor
Ferring Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 10, 2014
Start date
Jan 2015
Primary completion
Jan 14, 2019
Completion
Jan 14, 2019
Last update
May 20, 2022

Study contacts

Global Clinical Compliance
study director · Ferring Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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