Double-blind, Randomised, Placebo-controlled, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Budesonide Capsules Versus Placebo for Maintenance of Remission in Patients With Collagenous Colitis

Dr. Falk Pharma GmbH2 sites in 2 countries92 target enrollmentApril 2008

ConditionsInduction and Maintaining Remission of Collagenous Colitis

InterventionsBudesonide Placebo

DrugsBudesonide Placebo

Overview

Phase: Phase 3
Intervention: Budesonide
Conditions: Induction and Maintaining Remission of Collagenous Colitis
Sponsor: Dr. Falk Pharma GmbH
Enrollment: 92
Locations: 2
Primary Endpoint: Proportion of patients being in remission over 52 weeks.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

September 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dr. Falk Pharma GmbH

Responsible Party

Sponsor

Eligibility Criteria

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,
•Diabetes mellitus, infection, glaucoma, tuberculosis, peptic ulcer disease, or hypertension if careful medical monitoring is not ensured,
•Known established cataract,