Ulcerative Colitis extending proximally beyond the rectum with bleeding, verified by endoscopic examination MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis
Conditions
Interventions
Trade Name: Clipper
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Beclomethasone diproprionate
CAS Number: 5534-09-8
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Chiesi Farmaceutici SpA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pre-inclusion criteria at screening visit: - male or female = 18 and = 70 years old; - women of child-bearing potential using effective contraceptive methods; - history and documented diagnosis of ulcerative colitis, dated from more than 3 months; Rectal bleeding score = 1; - Stable dosage of ongoing oral mesalazine therapy (maximum dosage 3.2 g/day) For patients under treatment with other oral medication containing 5 ASA maximum allowed dosage at study entry is: balsalazide (6.7 g/day), or olsalazine (2 g/day) or sulfasalazine (3 g/day) in the last 14 days; - Able to understand and to follow the protocol; - Having given written informed consent for study participation; Inclusion criteria at randomization (end of run-in period) - Endoscopic score = 1 in one or more colon segments; - DAI score = 3 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria at screening: - Women of childbearing potential not using adequate contraceptive methods; - Pregnant women or breast-feeding women; - Severe ulcerative colitis or toxic megacolon; - Infectious Colitis; - Ischemic Colitis; - Colitis induced by drug or radiotherapy; - Chron's disease; - Major gastro-intestinal surgery other than appendectomy; - Evolutive active peptic ulcer or medical history of peptic ulcer complications; - Non compensated diabetes mellitus; - Non controlled arterial hypertension (SBP = 160 mm Hg and or DBP = 100 mm Hg) - Hyperthyroidism; - Medical history of concomitant cancer or other disease which, according to Investgators' opinion could interfere with the evaluation of the test drug; - Poorly controlled pulmonary infections (tubercolosis, active mycotic infections); - Patients receiving oral or injectable corticosteroids (oral budesonide included) within 30 days from screening visit, rectal corticosteroids (suppositories, enema, foams), inhaled corticosteroids in the 14 days prior to screening visit; - Change in the dose of oral Mesalazine treatment, in the 14 days prior the screening visit or at a dosage superior to 3.2 g/day or balsalazide (6.7 g/day), olsalazine (2 g/day), or sulfasalazine (3 g/day); - Patients being treated with H2-receptor antagonists or proton pump inhibitor (PPIs) in the previous 2 weeks ; - Use of immunomodulators or immunodepressants in the previous 3 months; - Patients treated with TNF-alfa antagonists in the previous 6 months; - Antibiotic treatment that cannot be stopped before randomization; - History of drug or alcohol abuse; - Patients who took part to another trial in the previous 3 months- Exclusion criteria at randomization (end of run-in period) - Severe ulcerative colitis (DAI > 10); - Positive ova and parasitic stool examination; - Ulcerative Colitis with endoscopic store 1.5 mg/dL); - Any abnormal laboratory test which could interfere with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy objective of the trial is to demonstrate that the response to the treatment, measured in terms of DAI after 4 weeks of treatment, is not inferior in BDP group, compared to the one detected in the Prednisone group. The primary safety objective is to demonstrate a better safety profile in terms of steroid toxicity and reduction of endogenous cortisol production of BDP treatment compared to Prednisone treatment after 4 weeks of treatment;Secondary Objective: Evaluation of efficacy of the 2 treatments in terms of improvements of disease related symptoms, general condition and disease severity, measured at week 4 and week 8; Evaluation of the overall safety profile of the two treatment regimens after 4 and 8 weeks of treatment.;Primary end point(s): The primary variable will be the percentage of patients with clinical response, defined as a DAI score < 3 or reduced of at least 3 points for patients with a baseline DAI = 7 after 4 weeks of treatment with test drugs. The secondary variables will be: percentage of patients with clinical response after 4 weeks of treatment without steroid-related adverse event (AEs), including cortisol levels < 5 mcg/dL (or< 150 nmol/L); percentage of patients with DAI score = 1 after 4 weeks of treatment; change in DAI total score after 4 weeks of treatment; change in endoscopic store after 4 weeks of treatment; change in CAI total score after 4 and 8 weeks of treatment; changes in CRP, ESR, after 4 and 8 weeks of treatment. The primary safety variable will be the percentage of patients with adverse events related to steroidal treatment including morning serum cortisol < 5 mcg/dL (or < 150 nmol/L) during the second 4 weeks of treatment (after visit 4 to Visit 6); changes from baseline to visits after 4 and 8 weeks of treatment (from Visit 2 to 4). The secondary varables will be: percentage of patients with adverse events related to steroid treatment including morning serum cortisol < 5 mcg/dL (or < 150 | — |
Countries
Belgium, Italy, Poland, Spain
Outcome results
None listed