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Recruitment has now finished

 

Bauch

Symptoms: 

Bloody diarrhoea or convulsive abdominal pain

Age

Age: 

18-75 

Drug

Treatment:

 8-week combined treatment of oral mesalazine and novel budesonide suppositories vs. mesalazine monotherapy

Which disease is treated?

Acute ulcerative colitis – chronic inflammation of the intestine mucosa (state of disease: mild to moderate) 

The ulcerative colitis is a chronic inflammatory bowel disease that exclusively affects the large intestine and usually occurs episodically. Symptoms of ulcerative colitis are bloody diarrhea, often mixed with mucus. Patients also complain of convulsive abdominal pain. Depending on the severity of the disease, affected persons can live without symptoms for many months, while in the case of acute phases hospitalizations may be necessary. 

Trial Phase: III

Study Design: Randomized · Double-blind · Placebo-controlled · Multi-centre

What is the primary objective of the study?

  • To prove the superiority of combined treatment of oral mesalazine and novel budesonide suppositories vs. oral mesalazine monotherapy in regard to early response after 4 weeks of treatment in patients with acute ulcerative colitis (UC). 
Colitis

What is the duration of the study?  

  • The treatment period is 8 weeks. 

Who can participate in this study?  

  • Man or woman between 18 and 75 years of age with acute ulcerative colitis (mild to moderate),
  • New diagnosis or established disease, 
  • diagnosis confirmed by total colonoscopy and biopsy during screening phase of the clinical trial 

 

Who cannot participate in this study?  

Patients who meet one of the following criteria: 

  • Crohn’s disease, indeterminate colitis, ischemic colitis, diverticular disease-associated colitis, microscopic colitis 
  • Presence of colitis of a different origin (e.g. infectious or parasitic, drug-induced), 
  • Previous colonic surgery (except appendectomy, haemorrhoidectomy, and endoscopic removal of polyps), 
  • Existing or intended pregnancy or women currently breastfeeding 
  • Participation in another clinical trial within the last 30 days prior to screening and having received study medication or simultaneous participation in another clinical trial or previous participation in this trial and having received study medication. 

The trial was conducted in the following countries  

  • Bulgaria 
  • Germany 
  • Latvia 
  • Poland 
  • Russian Federation 
  • Ukraine