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Completed

NCT Number: NCT01966783

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

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

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Key information

Conditions

Proctitis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charité-Campus Benjamin Franklin Universitätsmedizin Berlin, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide 2 mg suppository

Drug

per day

Budesonide 4 mg suppository

Drug

per day

Mesalazine 1 g suppository

Drug

per day

Budesonide 2 mg suppository/Mesalazine 1 g suppository

Drug

per day

Primary outcomes

  1. Resolution of clinical symptoms

    Time frame: 8 weeks

    Symptoms as reported in the diary

Secondary outcomes

  1. Rate of clinical and endoscopic remission

    Time frame: 8 weeks

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

  2. Rate of improvement

    Time frame: 8 weeks

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

  3. Rate of patients with clinical remission

    Time frame: 8 weeks

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

  4. Rate of patients with endoscopic remission

    Time frame: 8 weeks

    Ulcerative colitis-disease activity index

Sponsors and collaborators

Lead sponsor

Dr. Falk Pharma GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 22, 2013
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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