collagenous colitis MedDRA version: 20.0 Level: LLT Classification code 10048928 Term: Colitis collagenous System Organ Class: 100000004856
Conditions
Interventions
Trade Name: CLIPPER - 5 MG COMPRESSE GASTRORESISTENTI A RILASCIO PROLUNGATO 30 COMPRESSE
Product Name: CLIPPER
Product Code: [-]
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: BECLO
Sponsors
I.R.C.C.S. POLICLINICO SAN DONATO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or Female patients =18 and =85 years. • History of watery diarrhea without blood for at least 12 weeks before the start of treatment (baseline) in patients with newly diagnosed CC, or history of clinical recurrence lasting more than one month prior to screening in patients with known diagnosis of CC . • At least 21 evacuations during the 7 days preceding the start of treatment (baseline), of which at least one evacuation a day of liquid / semiformate stools during the 7 days preceding the start of treatment. • Complete colonoscopy performed in the last 12 weeks before the start of treatment (baseline) with histological diagnosis of CC according to histopathological criteria defined by Langner et al. in 2015. Only patients with confirmed diagnosis of CC will be enrolled in the study. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
Exclusion criteria: • Infectious chronic diarrhea (ie detection of bacterial pathogens / parasites in stool or rectal biopsies). • Diarrhoea caused by other symptomatic organic diseases of the gastrointestinal tract or traceable to defined endoscopic-histological findings (ie ulcerative colitis, ischemic colitis, post-actinic colitis, Crohn's disease, tumors, polyps> 2 cm). • Celiac disease (serological tests, eg. Total IgA and anti-transglutaminase IgA must be performed) or active hyperthyroidism when the effectiveness of the treatment is not optimal ( blood tests, for example. TSH-r must be performed). • Suspected drug-induced CM or drug-induced diarrhea (eg. Olmesartan, metformin) [Verhaegh 2016]. • Previous extended colon resections. • Previous radiation therapy directed to the abdominal and pelvic region. • diverticular disease in acute or complicated phase (eg. post-diverticulitis stenosis). • Known hereditary forms of intolerance to lactose or fructose, of glucose-galactose impaired absorption, of sucrase-isomaltase insufficiency, , of Lapp lactase deficiency or congenital deficiency of lactase. • History of invasive cancer in the last five years. • Severe comorbidities that substantially reduce life expectancy. • Abnormal liver function (ALT or ALP> 2.5 x ULN), liver cirrhosis or portal hypertension; impaired renal function. • Known cataracts. • Hemorrhagic diathesis. • Peptic disease in the active phase. • Asthma, diabetes, infections, osteoporosis, glaucoma, tuberculosis or uncontrolled hypertension despite the specific therapy. • cardiovascular, renal, endocrine or severe psychiatric disorders. • Known intolerance / hypersensitivity to the IMP or to drugs with similar chemical structure or pharmacological profile. • Treatment with anti-diarrheal drugs (eg. Loperamide), Boswellia serrata extract, cholestyramine or bulking agents within 14 days before the start of treatment (baseline). • Treatment with immunomodulators (eg, Thiopurines or methotrexate) or anti-TNF in the 3 months preceding the start of treatment (baseline). • Treatment with budesonide, BDP, mesalazine, steroids or oral antibiotics within 4 weeks before the start of treatment (baseline). • treatment with ketoconazole or other CYP3A -inhibitors within 3 weeks before the start of treatment (baseline). • Addiction to alcohol or drugs in the previous years. • Pregnant or breast-feeding. • Participation in another clinical trial within 30 days prior or previous participation in this same trial. • reduction of surrenal function • Concomitant infections with Mycobacterium tubercolosis, mycotic or viral.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the efficacy of BDP 5 mg extended release tablets, administered once daily for 8 weeks, in inducing a clinical response, defined as a reduction of at least 50% in the frequency of bowel movements with respect to the number of evacuations to ' start of treatment (baseline), evaluated in the 7 days preceding the visit at week 8;Secondary Objective: • To assess the safety and tolerability of BDP in patients with CC • To evaluate the efficacy of BDP in inducing a clinical response, defined as a reduction of at least 50% in the frequency of bowel movements with respect to the number of evacuations beginning of treatment (baseline) and evaluated in the 7 days preceding the visit a week 4 • To evaluate the efficacy of BDP in inducing clinical remission, defined as having a maximum of 21 evacuations (=3 on average per day), including a maximum of 6 watery stools, during the week before the visits at weeks 4 and 8. • To evaluate the efficacy of BDP in patients with CC, at 24:24 weeks after discontinuation of BDP. • To evaluate the efficacy of BDP in the treatment of clinical relapses in patients who have responded to previous treatment with BDP • To evaluate the efficacy of BDP on the resolution of the histological lesions at week 8. • Evaluate the BDP impact on the quality of life of patients;Primary end point(s): At least 50% reduction of evacuation frequency compared to the start of treatment (baseline);Timepoint(s) of evaluation of this end point: In the 7 days preceding week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): At least 50% reduction of evacuation frequency compared to the start of treatment (baseline); Clinical remission rate, defined as a maximum of 21 evacuations including no more than 6 evacuations of watery stools ; Time to symptoms resolution (the first of seven consecutive days with no more than 3 evacuations per day or less than 1 evacuation of watery stools per day or no more than 3 evacuations per day of which less than 1 evacuation of watery stools per day ); Impact on stools consistency (watery, half-watery/solid) as per Bristol stool scale; Impact on quality of life as per Short Health Scale (SHS); Rate of patients with hystologic remission; Rate of patients with hystologic improvement ; primary non-responders rate; Rate of primary responders in clinical remission and rate of primary responders in clinical relapse; Rate of clinical remission and clinical response in primary responders having a clinical relapse, and time to relapse; Impact on the Physician’s Global Assessment (PGA); Impact on abdominal pain;Timepoint(s) of evaluation of this end point: In the 7 days preceding week 4; At weeks 4 and 8; All study duration; All study duration; Weeks 4 and 8; Week 8; Week 8; Weeks 4 and 8; Weeks 12 and 24; All study duration; Study end; All study duration | — |
Countries
Italy
Outcome results
None listed