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Symptoms: Bloody diarrhoea or convulsive abdominal pain

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Age: 18-75

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Treatment: 8 weeks with
suppositories/rectal foam

Which disease is treated?

Acute ulcerative proctitis – 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:

RANDOMISED • DOUBLE-BLIND DOUBLE-DUMMY • MULTI CENTRE

Why is the study carried out?

The aim of this study is to compare the efficacy and safety of a once-daily treatment with a new suppository compared to a once-daily treatment with rectal foam in patients with acute ulcerative proctitis

 

What are the objectives of the study?

  • To prove the non-inferiority of an 8-week daily treatment with a new budesonide suppository compared to established budesonide rectal foam in patients with acute ulcerative proctitis.
  • To assess safety and tolerability in the form of adverse events and laboratory parameters
  • To assess patients’ acceptance and preference of the investigational medicinal products
Colitis

What is the duration of the study?

The treatment period is 8 weeks.

WHO CAN PARTICIPATE IN THIS STUDY?

  • Men or women between 18 and 75 years with diagnosed acute ulcerative proctitis (mild to moderately active).
  • The diagnosis must be confirmed by colonoscopy or sigmoidoscopy during the study.

WHO CANNOT PARTICIPATE IN THIS STUDY?

Patients who meet one of the following criteria:

  • Other chronic bowel diseases such as Crohn’s disease, indeterminate colitis, ischemic colitis, diverticular associated colitis, microscopic colitis.
  • Presence of proctitis of a different origin (e.g. infectious or parasitic, drug-induced)
  • Previous colonic surgery (except appendectomy, haemorrhoidectomy, and endoscopic removal of polyps)
  • Presence of a symptomatic organic disease of the gastrointestinal tract (with the exception of non-bleeding hemorrhoids or hiatus hernia)
  • Local intestinal infection (i.e. pathogenic bacteria or Clostridium dif cile toxin in stool culture)
  • Oral/rectal/intravenous corticosteroids therapy within the last 4 weeks before the start of the study.
  • 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.

In which countries trial sites are planned?

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We offer our service in the following countries:

  • Germany
  • Poland

Further countries:

  • Hungary
  • Latvia
  • Russia
  • Slovakia
  • Ukraine