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
- Conditions
- Induction of remission in lymphocytic colitisMedDRA version: 19.0Level: LLTClassification code 10025268Term: Lymphocytic colitisSystem Organ Class: 100000004856Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
- Registration Number
- EUCTR2008-005994-36-SE
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
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 randomisation in patients with newly diagnosed lymphocytic colitis, or history of clinical relapse for more than 1 week prior 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 enteric duration of the highly effective method of birth control, which is defined as those which result in alow 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
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.Doubt about the patient’s cooperation, e.g. because of addiction to alcohol or drugs,
24.Existing or intended pregnancy or breast-feeding,
25.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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of the trial is to compare the efficacy of 9 mg budesonide/day and 3 g mesalazine/day compared to placebo for the induction of remission in lymphocytic colitis;Secondary Objective: - To compare the efficacy of 3 g mesalazine/day vs. 9 mg budesonide/day for the induction of remission in lymphocytic colitis,<br>- To study safety and tolerability of 9 mg budesonide/day and 3 g mesalazine/day vs. placebo in the form of adverse events and laboratory parameters,<br>- To assess patients’ quality of life<br>;Primary end point(s): Rate of clinical remission, defined as a maximum of 21 stools, thereof not more than 6 watery stools in the last 7 days prior the visit at week 8 (LOCF);Timepoint(s) of evaluation of this end point: Patient Visit V5 after 8 weeks of treatment
- Secondary Outcome Measures
Name Time Method