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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

Who can participate

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

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 corticosteroids 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
04

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

  • DrugBudesonide 2 mg suppository

    per day

  • DrugBudesonide 4 mg suppository

    per day

  • DrugMesalazine 1 g suppository

    per day

  • DrugBudesonide 2 mg suppository/Mesalazine 1 g suppository

    per day

05

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

06

Study locations

2 sites
  • Charité-Campus Benjamin Franklin Universitätsmedizin Berlin
    Berlin, 12203, Germany
  • Evang. Krankenhaus Kalk, Medical Department
    Cologne, 51103, Germany
07

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 ↗
08

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
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