CompletedPhase 3

SOIBD Collagenous Colitis Maintenance Study

Germany, Sweden92 participantsStarted 2008-04

Plain-language summary

This study aims to demonstrate the superiority of budesonide compared to placebo as maintenance therapy in keeping patients in remission over a one-year period

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Signed informed consent,
✓. Patients aged \>= 18 years,
✓. Histologically established diagnosis of collagenous colitis (CC) defined as:
✓. Thickened sub-epithelial collagen layer \>= 10 µm on well-orientated sections,
✓. Increased amount of inflammatory cells indicating chronic inflammation in the lamina propria,
✓. History of non-bloody, watery diarrhoea for more than 2 weeks prior screening in patients with newly diagnosed collagenous colitis, or history of clinical relapse for more than 1 week prior screening in patients with previously established collagenous colitis,
✓. A mean of \>= 3 stools/day, thereof a mean of \>= 1 watery stools/day, during the week prior baseline,
✓. Women of child-bearing potential and being heterosexually active have to apply appropriate contraceptive methods, e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a condom and spermicide), or partner has undergone vasectomy. The investigator is responsible for determining whether the subject has adequate birth control for study participation.

Exclusion criteria

✕. Other significant abnormalities at colonoscopy that may have been the cause of diarrhoea, with the exception of colonic diverticulosis and polyps \< 2 cm,
✕. Infectious cause of diarrhoea,
✕. Untreated active celiac disease,
✕. Clinical suspicion of drug-induced collagenous colitis,
✕. Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder,
✕. Abnormal hepatic function (ALT or ALP \> 2.5 x upper limit of normal \[ULN\]), liver cirrhosis, or portal hypertension,
✕. Local intestinal infection,
✕. Radiation therapy towards the abdominal or pelvic region,

What they're measuring

Proportion of patients being in remission over 52 weeks.

Timeframe: 52 weeks

Trial details

NCT IDNCT01278082

SponsorDr. Falk Pharma GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-03

View on ClinicalTrials.gov More Induction and Maintaining Remission of Collagenous Colitis trials