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

Proctitis Clinical Trial

Official title:

Randomized, Double-blind, Multicentre Study to Compare the Efficacy and Safety of Budesonide Versus Mesalazine Suppository Versus a Combination Therapy of Budesonide/Mesalazine Suppositories in Patients With Acute Ulcerative Proctitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01966783
• Other study ID #: BUS-2/UCA
• Secondary ID: 2012-003362-41
• Status: Completed
• Phase: Phase 2
• Start date: September 2013
• Est. completion date: August 2015

Study information

• Verified date: May 2019
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Active ulcerative proctitis

• Diagnosis confirmed by endoscopy

• Established disease or new diagnosis

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

Related Conditions & MeSH terms

• Proctitis

Intervention

Drug:
• Budesonide 2 mg suppository
per day
• Budesonide 4 mg suppository
per day
• Mesalazine 1 g suppository
per day
• Budesonide 2 mg suppository/Mesalazine 1 g suppository
per day

Locations

Country	Name	City	State
Germany	Charité-Campus Benjamin Franklin Universitätsmedizin Berlin	Berlin
Germany	Evang. Krankenhaus Kalk, Medical Department	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of clinical symptoms	Symptoms as reported in the diary	8 weeks
Secondary	Rate of clinical and endoscopic remission	Symptoms as reported in the diary, ulcerative colitis-disease activity index	8 weeks
Secondary	Rate of improvement	Symptoms as reported in the diary, ulcerative colitis-disease activity index	8 weeks
Secondary	Rate of patients with clinical remission	Symptoms as reported in the diary, ulcerative colitis-disease activity index	8 weeks
Secondary	Rate of patients with endoscopic remission	Ulcerative colitis-disease activity index	8 weeks