Induction of remission in lymphocytic colitis MedDRA version: 19.0 Level: LLT Classification code 10025268 Term: Lymphocytic colitis System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Salofalk® Granu-Stix® 1,5 g
Pharmaceutical Form: Gastro-resistant granules
INN or Proposed INN: MESALAZINE
CAS Number: 89-57-6
Concentration unit: g gram(s)
Concentration type: equal
Conce
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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., =65 years) yes F.1.3.1 Number of subjects for this age range 52
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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, - 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, - To assess patients’ quality of life ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Double-blinded phase: • Number (%) of patients with a maximum of 21 stools, thereof not more than 6 watery stools in the last 7 days prior the visit at week 2, 4, 6 and 8, • Number (%) of patients with a maximum of 21 stools in the last 7 days prior the visit at week 2, 4, 6, 8, and 8 (LOCF), • Number (%) of patients with a maximum of 6 watery stools in the last 7 days prior the visit at week 2, 4, 6, 8, and 8 (LOCF), • Number (%) of patients with baseline mean of > 3 stools/day, who have a mean of ? 3 stools/day AND a reduction of at least 1 stool from baseline in the last 7 days prior the visit at week 2, 4, 6, 6 (LOCF), 8, and 8 (LOCF), • Times to resolution of symptoms defined as the first of 7 consecutive days with: o ? 3 stools/day on average, or o 3 stools/day) in each week, • Number of days in each week with watery, soft, soft or solid, or solid stool consistency, respectively, • Average frequency of stools/day in each week, • Quality of life (by GIQLI, SHS) • Physician’s Global Assessment (PGA) • Change of disease activity from baseline to week 8 /LOCF) Open-label phase: • Number (%) of patients experiencing clinical remission, defined as a maximum of 21 stools, thereof not more than 6 watery stools in the last 7 days prior to the visit at week 4 (LOCF) of the open-label phase, • Change of disease activity from start to open-label phase to week 4 /LOCF) • Change of quality of life (by GIQLI, SHS) from start of open-label phase to week 4 (LOCF) • Physician's Global Assessment (PGA);Timepoint(s) of evaluation of this end point: Each visit | — |
Countries
Belgium, Czech Republic, Denmark, Germany, Hungary, Lithuania, Netherlands, Spain, Sweden
Contacts
Public ContactProject Manager
Dr. Falk Pharma GmbH
Outcome results
None listed