Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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3 July 2017 |
Main ID: |
EUCTR2014-005635-14-LV |
Date of registration:
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23/02/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis
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Scientific title:
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Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis - Budesonide 9 mg capsules in active UC |
Date of first enrolment:
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10/07/2015 |
Target sample size:
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60 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005635-14 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Hungary
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Latvia
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Lithuania
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Contacts
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Name:
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Clinical Research and Development
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Address:
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Leinenweberstraße 5
79108
Freiburg
Germany |
Telephone:
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+4976115140 |
Email:
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Affiliation:
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Dr. Falk Pharma GmbH |
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Name:
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Clinical Research and Development
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Address:
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Leinenweberstraße 5
79108
Freiburg
Germany |
Telephone:
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+4976115140 |
Email:
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Affiliation:
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Dr. Falk Pharma GmbH |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Signed informed consent,
2. Men or women aged 18 to 75 years,
3. Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology,
4. Established disease (presence of blood and/or mucus in the stools) or new diagnosis (presence of blood in the stools for at least 14 days prior to baseline visit),
5. Clinical Activity Index (CAI) > 4 and = 12 and Endoscopic Index (EI) = 4,
6. Insufficient response or intolerance to a previous or current treatment with mesazaline -containing or -releasing drugs
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 54 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria: 1. Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete microscopic colitis), diverticular disease associated colitis,
2. Toxic megacolon or fulminant colitis,
3. Colon resection,
4. Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening),
5. Malabsorption syndromes,
6. Celiac disease,
7. Bleeding hemorrhoids,
8. Active peptic ulcer disease
9. Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding,
10. Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, psychiatric disorders or infection if careful medical monitoring is not ensured,
11. Any severe infectious disease (e.g., tuberculosis, AIDS),
12. Severe co-morbidity substantially reducing life expectancy,
13. History of colorectal cancer,
14. History of cancer (other than colorectal) in the last 5 years, except for basal cell carcinoma,
15. Immunosuppressants, TNF-alpha-antagonists or anti-integrin therapy within 3 months and/or corticosteroids (oral, inhalative, intravenous [IV] or topical rectal) within 4 weeks prior to baseline,
16. Current relapse occurred under maintenance treatment with > 2.4 g mesalazine per day,
17. Abnormal renal function (Serum Cystatin C > upper limit of normal [ULN]) at screening visit,
18. Abnormal hepatic function (ALT, AST or AP > 2.5 x ULN) or liver cirrhosis at screening visit,
19. Known intolerance/hypersensitivity/resistance to the IMP or drugs of similar chemical structure or pharmacological profile, or to any of the other constituents of the IMP,
20. Doubt about the patient’s cooperation, e.g., because of addiction to alcohol, drugs or medicines,
21. Existing or intended pregnancy or breast-feeding,
22. Participation in another clinical trial within the last 30 days prior to screening visit, simultaneous participation in another clinical trial, or previous participation in this trial and having received IMP.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Patients with active ulcerative colitis MedDRA version: 18.0
Level: LLT
Classification code 10045365
Term: Ulcerative colitis
System Organ Class: 100000004856
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Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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Intervention(s)
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Product Name: Budesonide 9 mg capsules, hard (BUX-PV) Pharmaceutical Form: Capsule, hard INN or Proposed INN: BUDESONIDE CAS Number: 51333-22-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 9-
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Primary Outcome(s)
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Primary end point(s): Rate of clinical remission at final/withdrawal visit
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Main Objective: The primary objective is to evaluate the efficacy of a 8-week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis.
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Timepoint(s) of evaluation of this end point: After 8 weeks of treatment
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Secondary Objective: Secondary objectives are to study safety and tolerability in the form of adverse events and laboratory parameters.
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Secondary Outcome(s)
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Secondary end point(s): • Rate of clinical improvement at final/withdrawal visit
• Number of stools per week
• Number of bloody stools per week
• Number of days with urgency per week
• Time to first resolution of clinical symptoms
• Rate of endoscopic remission/improvement at final/withdrawal visit
• Rate of histological remission/improvement at final/withdrawal visit
• Course of faecal calprotectin
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Timepoint(s) of evaluation of this end point: Each visit, if not otherwise defined.
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Secondary ID(s)
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BUX-3/UCA
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Source(s) of Monetary Support
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Dr. Falk Pharma GmbH
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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