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CompletedNCT01966783Updated May 7, 2019

Budesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulcerative Proctitis

A Phase 2 interventional study of Budesonide 2 mg suppository and Budesonide 4 mg suppository in Proctitis, sponsored by Dr. Falk Pharma GmbH. Completed at 2 sites in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-05-07.

Sponsored by Dr. Falk Pharma GmbH · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis.

02

Conditions studied

  • Proctitis

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03

In context

Proctitis

27 studies on the registry are indexed under Proctitis; 6 are open to participants now.

This study's planned enrollment of 320 is above the median of 122 across 23 interventional studies indexed under Proctitis.

Browse Proctitis studies →

Lead sponsor

Dr. Falk Pharma GmbH is the lead sponsor of 39 studies on the registry; 3 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Active ulcerative proctitis
  • Diagnosis confirmed by endoscopy
  • Established disease or new diagnosis

Exclusion criteria

Exclusion Criteria:

  • Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular assoc. colitis, microscopic colitis
  • Presence of proctitis of a different origin
  • Prior bowel resection
  • Presence of symptomatic organic disease of the gastrointestinal tract
  • Asthma, tuberculosis, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, infection if careful medical monitoring is not ensured
  • Local intestinal infection
  • Abnormal hepatic or renal function
  • Oral/rectal/intravenous therapy
  • Existing or intended pregnancy or breast-feeding
  • Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
320 participants (estimated)

Study arms

  • Experimental
    Budesonide dosage 1

    Budesonide 2 mg suppository

    Drug: Budesonide 2 mg suppository

  • Experimental
    Budesonide dosage 2

    Budesonide 4 mg suppository

    Drug: Budesonide 4 mg suppository

  • Active comparator
    Mesalazine

    Mesalazine 1g suppository

    Drug: Mesalazine 1 g suppository

  • Experimental
    Combination

    Budesonide 2 mg suppository/Mesalazine 1 g suppository

    Drug: Budesonide 2 mg suppository/Mesalazine 1 g suppository

Interventions

06

What researchers measure

Primary outcomes

  1. Resolution of clinical symptoms

    Symptoms as reported in the diary

    Time frame: 8 weeks

Secondary outcomes

  1. Rate of clinical and endoscopic remission

    Symptoms as reported in the diary, ulcerative colitis-disease activity index

    Time frame: 8 weeks

  2. Rate of improvement

    Symptoms as reported in the diary, ulcerative colitis-disease activity index

    Time frame: 8 weeks

  3. Rate of patients with clinical remission

    Symptoms as reported in the diary, ulcerative colitis-disease activity index

    Time frame: 8 weeks

  4. Rate of patients with endoscopic remission

    Ulcerative colitis-disease activity index

    Time frame: 8 weeks

07

Study locations

2 sites
  • Charité-Campus Benjamin Franklin Universitätsmedizin Berlin
    Berlin, 12203, Germany
  • Evang. Krankenhaus Kalk, Medical Department
    Cologne, 51103, Germany
08

References and documents

Publications

  • Kruis W, Neshta V, Pesegova M, Alekseeva O, Andreev P, Datsenko O, Levchenko O, Abdulkhakov S, Lozynskyy Y, Mostovoy Y, Soloviev K, Dorofeyev AE, Vieth M, Stiess M, Greinwald R, Mohrbacher R, Siegmund B. Budesonide Suppositories Are Effective and Safe for Treating Acute Ulcerative Proctitis. Clin Gastroenterol Hepatol. 2019 Jan;17(1):98-106.e4. doi: 10.1016/j.cgh.2018.04.027. Epub 2018 Apr 24. PubMed 29702300 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2013, a primary completion of Aug 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2013
First posted
Oct 22, 2013
Start
Sep 2013
Primary completionActual
Aug 2015
CompletionActual
Aug 2015
Last update
May 7, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01966783
Lead sponsor
Dr. Falk Pharma GmbH
Responsible party
Sponsor
First posted
Oct 22, 2013
Start date
Sep 2013
Primary completion
Aug 2015
Completion
Aug 2015
Last update
May 7, 2019

Study contacts

Wolfgang Kruis, Professor
principal investigator · Evang. Krankenhaus Kalk, Medical Department
Britta Siegmund, Professor
principal investigator · Charité-Campus Benjamin Franklin Universitätsmedizin Berlin

Oversight

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

Not currently enrolling

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