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

Information source: Dr. Falk Pharma GmbH
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Proctitis

Intervention: Budesonide 2 mg suppository (Drug); Budesonide 4 mg suppository (Drug); Mesalazine 1 g suppository (Drug); Budesonide 2 mg suppository/Mesalazine 1 g suppository (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Dr. Falk Pharma GmbH

Official(s) and/or principal investigator(s):
Wolfgang Kruis, Professor, Principal Investigator, Affiliation: Evang. Krankenhaus Kalk, Medical Department
Britta Siegmund, Professor, Principal Investigator, Affiliation: Charité-Campus Benjamin Franklin Universitätsmedizin Berlin

Overall contact:
Ralf Mohrbacher, MSc, Phone: ++49-761-1514-0, Ext: 156, Email: mohrbacher@drfalkpharma.de

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Resolution of clinical symptoms

Secondary outcome:

Rate of clinical and endoscopic remission

Rate of improvement

Rate of patients with clinical remission

Rate of patients with endoscopic remission

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Ralf Mohrbacher, MSc, Phone: ++49-761-1514-0, Ext: 156, Email: mohrbacher@drfalkpharma.de

Charité-Campus Benjamin Franklin Universitätsmedizin Berlin, Berlin 12203, Germany; Recruiting
Britta Siegmund, Professor, Phone: ++40 30 450514, Ext: 322, Email: britta.siegmund@charite.de
Britta Siegmund, Professor, Principal Investigator

Evang. Krankenhaus Kalk, Medical Department, Cologne 51103, Germany; Recruiting
Wolfgang Kruis, Professor, Phone: ++49 221 8289, Ext: 5289, Email: kruis@evkk.de
Wolfgang Kruis, Professor, Principal Investigator

Additional Information

Starting date: September 2013
Last updated: February 9, 2015

Page last updated: August 23, 2015

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