Randomised, double-blind, placebo-controlled, multi-centre trial on the efficacy and safety of budesonide for induction of remission in incomplete microscopic colitis

Phase 3

Completed

Conditions: Incomplete microscopic colitis
inflammation large intestine
10017969

Registration Number: NL-OMON45182

Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1

Inclusion Criteria

1. Signed informed consent,
2. Man or woman between 18 and 80 years of age,
3. Histologically established diagnosis of incomplete microscopic colitis (MCi) defined as the following findings in at least two segments of the colon:
* increased lymphoplasmacellular infiltrate in the lamina propria and
* thickened subepithelial collagenous band > 5 *m and < 10 *m and/or
* abnormal intraepithelial lymphocytes > 5 and < 20 per 100 epithelial cells,
4. History of chronic non-bloody, watery diarrhoea for at least 4 weeks,
5. Clinically active disease (defined as a mean of * 3 stools/day, thereof a mean of * 1 watery stool/day during the week prior to randomisation),
6. Women of child-bearing potential have to apply during the entire duration of the study a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, some IUDs, sexual abstinence or vasectomised
partner. The investigator is responsible for determining whether the patient uses adequate birth control for study participation.

Exclusion Criteria

1. Other significant abnormalities in colonoscopy that may have been the cause of diarrhoea except for colonic diverticulosis and non-dysplastic polyps < 2 cm,
2. Infectious cause of diarrhoea (local routine stool samples, Clostridium difficile included) or history of infectious diarrhoea within the last 3 months prior inclusion or local intestinal infection,
3. Clinical suspicion of drug-induced diarrhoea,
4. Prior and present MC (i.e., all histological criteria for collagenous colitis or lymphocytic colitis fulfilled),
5. History of bowel resection,
6. Radiation therapy of the abdominal or pelvic region,
7. Positive antibody titres for celiac disease (tGT IgA + serum IgA),
8. Untreated active thyroid dysfunction,
9. Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder reducing life expectancy,
10. Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal [ULN]), liver cirrhosis, or portal hypertension,
11. Tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured,
12. History of colorectal cancer,
13. History of cancer (other than colorectal) in the last 5 years,
14. Therapy with immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate) within 3 months prior to baseline,
15. Treatment with budesonide or other steroids within 4 weeks prior to baseline,
16. Treatment with antibiotics within 4 weeks prior to baseline,
17. Treatment with anti-diarrhoeal drugs (e.g., loperamide, ispaghula, codeine,
and opium), cholestyramine, bulking agents, and spasmolytics within 2 weeks prior to baseline,
18. Known intolerance/hypersensitivity/resistance to the trial drug or drugs of similar chemical structure or pharmacological profile,
19. Current or intended pregnancy or breast-feeding,
20. Doubt about the patient*s cooperation, e.g. because of addiction to alcohol or drugs,
21. Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Rate of clinical remission at final/withdrawal visit (clinical remission<br /><br>defined as a mean of < 3 stools/day and a mean of < 1 watery stool/day during<br /><br>the week prior to the visit)</p><br>

Secondary Outcome Measures

Name	Time	Method

Updated 4/15/2024

Randomised, double-blind, placebo-controlled, multi-centre trial on the efficacy and safety of budesonide for induction of remission in incomplete microscopic colitis

Recruitment & Eligibility

Study & Design

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