Double-blind, double-dummy, randomised, placebo-controlled, multi-centre phase III study on the efficacy and tolerability of a 8-week treatment with 9 mg budesonide vs. 3 g mesalazine vs. placebo in patients with lymphocytic colitis

Phase 1

• Conditions: Induction of remission in lymphocytic colitis; MedDRA version: 19.0Level: LLTClassification code 10025268Term: Lymphocytic colitisSystem Organ Class: 100000004856; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2008-005994-36-DE
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-04
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1.Signed informed consent,
2.Man or woman >/= 18 years to = 90 years,
3.History of non-bloody, watery diarrhoea for at least 12 weeks prior to randomisation in patients with newly diagnosed lymphocytic colitis, or history of clinical relapse for more than 1 week prior to randomisation in patients with previously established lymphocytic colitis,
4.At least 28 stools within the last 7 days prior to baseline, thereof at least 20 watery/soft stools,
5.Complete colonoscopy (or proctosigmoidoscopy) within the last 12 weeks before screening,
6.Histologically confirmed diagnosis of lymphocytic colitis:
a. > 20 intraepithelial lymphocytes (IELs)/100 epithelial cells,
b. Signs of inflammation of the lamina propria,
c. Normal (i.e., < 10 µm) sub-epithelial collagen layer on well-orientated sections,
7.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, sexual abstinence or vasectomised partner. The investigator is responsible for determining whether the subject has adequate birth control for study participation.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52

Exclusion Criteria

1.Evidence of infectious diarrhoea (i.e., pathogenic bacteria in stool culture or rectal biopsies),
2.Diarrhoea as a result of the presence of other symptomatic organic disease(s) of the gastrointestinal tract or endoscopic-histological findings (i.e., collagenous colitis, ulcerative colitis, ischemic colitis, radiation colitis, Crohn’s disease, tumours, polyps > 2 cm),
3.Celiac disease (blood tests and/or oesophagogastroduodenoscopy with histological examination to be performed),
4.Suspicion of drug-induced lymphocytic colitis,
5.History of significant bowel resection,
6.History of radiation therapy towards the abdominal or pelvic region,
7.Post-diverticulitis stenosis,
8.Known hereditary problems of galactose or fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase insufficiency, Lapp lactase deficiency, or congenital lactase deficiency,
9.History of cancer in the last five years,
10.Severe co-morbidity substantially reducing life expectancy,
11.Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal [ULN]), liver cirrhosis, or portal hypertension,
12.Abnormal renal function (Cystatin C > ULN),
13.Local intestinal infection,
14.Known established cataract,
15.Hemorrhagic diathesis,
16.Active peptic ulcer disease,
17.Asthma, diabetes mellitus, infection, osteoporosis, glaucoma, tuberculosis, or hypertension if careful medical monitoring is not ensured,
18.Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder,
19.Known intolerance/hypersensitivity to study drugs or drugs of similar chemical structure or pharmacological profile,
20.Treatment with anti-diarrhoeals (e.g. loperamide), Boswellia serrata extract, cholestyramine. or bulking agents within the last 14 days before baseline,
21.Treatment with immunomodulators (e.g. azathioprine, 6-mercaptopurine, thioguanine or methotrexate) within 3 months before baseline,
22.Treatment with budesonide, mesalazine, steroids, or oral antibiotics within 4 weeks before baseline,
23. Treatment with ketoconazole or other CYP3A inhibitors within the last 3 weeks before baseline
24.Doubt about the patient’s cooperation, e.g. because of addiction to alcohol or drugs,
25.Existing or intended pregnancy or breast-feeding,
26.Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.
27. Live vaccination within the last 4 weeks before the baseline visit
28. Diagnosis of chickenpox, herpes zoster or measles within the last 3 months before the baseline visit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified