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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01966783
First received: October 9, 2013
Last updated: January 20, 2016
Last verified: January 2016
  Purpose
The purpose of this study is to investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis.

Condition Intervention Phase
Proctitis Drug: Budesonide 2 mg suppository Drug: Budesonide 4 mg suppository Drug: Mesalazine 1 g suppository Drug: Budesonide 2 mg suppository/Mesalazine 1 g suppository Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome Measures:
  • Resolution of clinical symptoms [ Time Frame: 8 weeks ]
    Symptoms as reported in the diary


Secondary Outcome Measures:
  • Rate of clinical and endoscopic remission [ Time Frame: 8 weeks ]
    Symptoms as reported in the diary, ulcerative colitis-disease activity index

  • Rate of improvement [ Time Frame: 8 weeks ]
    Symptoms as reported in the diary, ulcerative colitis-disease activity index

  • Rate of patients with clinical remission [ Time Frame: 8 weeks ]
    Symptoms as reported in the diary, ulcerative colitis-disease activity index

  • Rate of patients with endoscopic remission [ Time Frame: 8 weeks ]
    Ulcerative colitis-disease activity index


Estimated Enrollment: 320
Study Start Date: September 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Budesonide dosage 1
Budesonide 2 mg suppository
Drug: Budesonide 2 mg suppository
per day
Experimental: Budesonide dosage 2
Budesonide 4 mg suppository
Drug: Budesonide 4 mg suppository
per day
Active Comparator: Mesalazine
Mesalazine 1g suppository
Drug: Mesalazine 1 g suppository
per day
Experimental: Combination
Budesonide 2 mg suppository/Mesalazine 1 g suppository
Drug: Budesonide 2 mg suppository/Mesalazine 1 g suppository
per day

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01966783

Locations
Germany
Charité-Campus Benjamin Franklin Universitätsmedizin Berlin
Berlin, Germany, 12203
Evang. Krankenhaus Kalk, Medical Department
Cologne, Germany, 51103
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
Principal Investigator: Wolfgang Kruis, Professor Evang. Krankenhaus Kalk, Medical Department
Principal Investigator: Britta Siegmund, Professor Charité-Campus Benjamin Franklin Universitätsmedizin Berlin
  More Information

Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT01966783     History of Changes
Other Study ID Numbers: BUS-2/UCA
2012-003362-41 ( EudraCT Number )
Study First Received: October 9, 2013
Last Updated: January 20, 2016

Additional relevant MeSH terms:
Proctitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Rectal Diseases
Intestinal Diseases
Budesonide
Mesalamine
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 19, 2017