SOIBD Collagenous Colitis Maintenance Study

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Induction and Maintaining Remission of Collagenous Colitis

Intervention / Treatment
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* Drug: Budesonide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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, Diabetes mellitus, infection, glaucoma, tuberculosis, peptic ulcer disease, or hypertension if careful medical monitoring is not ensured, Known established cataract, Known hereditary problems of galactose or fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase insufficiency, Lapp lactase deficiency, or congenital lactase deficiency, Established osteoporosis with T-score < -2.5, Pregnancy or lactation, History of cancer in the last five years, History of significant bowel resection, Therapy with immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate) in the last 3 months, Treatment with oral, rectal, or intravenous corticosteroids including budesonide in the last month, Known intolerance/hypersensitivity to study drug or drugs of similar chemical structure or pharmacological profile, Patients who are unable to adhere to the study visit schedule and other protocol requirements according to the judgement of the investigator, Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Alternating daily dosing with 2 x 3 mg budesonide capsules OD and 1 x 3 mg budesonide capsule OD every second day | Drug: Budesonide<br>* Alternating daily dosing with 2 x 3 mg budesonide capsules OD and 1 x 3 mg budesonide capsule OD every second day<br>* Other names: Budenofalk 3mg capsules;|
| Placebo Comparator: B<br>Alternating daily dosing with 2 placebo capsules OD and 1 placebo capsule OD every second day. | Drug: Placebo<br>* Alternating daily dosing with 2 placebo capsules OD and 1 placebo capsule OD every second day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients being in remission over 52 weeks. | Remission is defined as a mean of < 3 stools/day, thereof a mean of < 1 watery stools/day | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients in remission at wk 4, 13, 26, and 39. | Remission is defined as a mean of < 3 stools/day, thereof a mean of < 1 watery stools/day | 39 weeks | 
| Adverse events (AEs) |  | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized, double-blind, Placebo-controlled, budesonide, collagenous colitis, acute treatment, maintaining remission